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Drug Info - Manufacturer

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- Chloroprocaine Hci Injection, Solution

Nesacaine 1% and 2% Injections, in multidose vials with methylparaben as preservative, are indicated for the production of local anesthesia by infiltration and peripheral nerve block. They are not to...

0.9% Sodium Chloride Injection, Solution

This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be...

10 Tree Mix- Acer Negundo Pollen, Betula Nigra Pollen, Black Walnut, Carya Ovata Pollen, Fraxinus Americana Pollen, Platanus Occidentalis Pollen, Populus Deltoides Subsp. Monilifera Pollen, Quercus Rubra Pollen, Salix Nigra Bark And Ulmus Crassifolia Pollen Injection, Solution4 Weed Mix- Amaranthus Retroflexus Pollen, Chenopodium Album Pollen, Plantago Lanceolata Pollen, Xanthium Strumarium Pollen Injection, Solutionbirch Mix- Betula Nigra, Betula Populifolia Injection, Solutionmixed Aspergillus- Aspergillus Niger, Aspergillus Repens, Aspergillus Oryzae, Aspergillus Terreus Injection, Solutionmixed Feathers- Gallus Gallus Feather, Anas Platyrhynchos Feather, Anser Anser Feather Injection, Solutionmixed Molds- Alternaria Alternata, Cladosporium Sphaerospermum, Aspergillus Niger, Aspergillus Repens, Aspergillus Oryzae, Aspergillus Terreus, Penicillium Chrysogenum, Penicillium Notatum Injection, Solutionmixed Penicillium- Penicillium Chrysogenum, Penicillium Notatum Injection, Solution

Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the o...

28 Remedy Repair- Dimethicone Cream

Indications & Usage: After using 28 REMEDY Intensive Serum (or Eye Repair Concentrate), dispense an appropriate amount on your palm and use fingers to gently spread on your face and neck along the...

4 Weed Mix- Amaranthus Retroflexus Pollen, Chenopodium Album Pollen, Plantago Lanceolata Pollen And Xanthium Strumarium Pollen Injection, Solution9 Tree Mix- Acer Saccharum Pollen, Alnus Rhombifolia Pollen, Betula Lenta Pollen, Carya Ovata Pollen, Fraxinus Americana Pollen, Platanus Occidentalis Pollen, Populus Alba Pollen, Quercus Alba Pollen And Ulmus Crassifolia Pollen Injection, Solution

These products are for diagnostic use only. Diagnostic allergenic extracts are indicated for use in skin testing to establish the clinical relevance of specific allergens to which the patient has been...

5 Grass Mix- Phleum Pratense Pollen, Dactylis Glomerata Pollen, Poa Pratensis Pollen, Agrostis Gigantea Pollen, Anthoxanthum Odoratum Pollen Injection, Solution3 Grass Mix- Bromus Inermis Pollen, Cynodon Dactylon, Cynodon Dactylon Injection, Solution4 Weed Mix- Amaranthus Retroflexus Pollen, Chenopodium Album Pollen, Plantago Lanceolata Pollen, Xanthium Strumarium Pollen ....... Americana Pollen, Platanus Occidentalis Pollen, Populus Alba Pollen, Quercus Alba Pollen, Ulmus Crassifolia Pollen Injection, Solutionmixed Ragweed- Ambrosia Artemisiifolia, Ambrosia Trifida Pollen Injection, Solutionwestern Weed Mix- Ambrosia Acanthicarpa Pollen, Ambrosia Psilostachya Pollen, Artemisia Tridentata Pollen, Bassia Scoparia Pollen, Salsola Kali Pollen Injection, Solution

Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants, in situations wher...

50% Magnesium Sulfate Injection, Solution

Magnesium Sulfate Injection, USP is suitable for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemi...

6% Hetastarch In 0.9% Sodium Chloride Injection, Solution

6% Hetastarch in 0.9% Sodium Chloride Injection is indicated in the treatment of hypovolemia when plasma volume expansion is desired. It is not a substitute for blood or plasma. The adjunctive use of ...

A

A. Dust- House Dust Injection, Solutionmattress Dust Injection, Solution

Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic sympto...

Abacavir And Lamivudine Tablet, Film Coated

Abacavir and lamivudine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection....

Abacavir And Lamivudine- Abacavir Sulfate And Lamivudine Tablet, Film Coated

Abacavir and Lamivudine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection....

Abacavir Solution

Abacavir oral solution in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection....

Abacavir Sulfate Tablet, Film Coated

Abacavir tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection....

Abacavir Sulfate, Lamivudine And Zidovudine Tablet

Abacavir, lamivudine and zidovudine tablet is indicated in combination with other antiretrovirals or alone for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Limitations of U...

Abacavir, Lamivudine And Zidovudine- Abacavir , Lamivudine And Zidovudine Tablet

Abacavir, lamivudine and zidovudine tablet is indicated in combination with other antiretrovirals or alone for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Limitations of Us...

Abacavir- Abacavir Sulfate Solution

Abacavir oral solution, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection....

Abacavir- Abacavir Sulfate Tablet, Film Coated

Abacavir tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection....

Abelcet- Amphotericin B, Dimyristoylphosphatidylcholine, Dl- And Dimyristoylphosphatidylglycerol, Dl- Injection

ABELCET is indicated for the treatment of invasive fungal infections in patients who are refractory to or intolerant of conventional amphotericin B therapy. This is based on open-label treatment of ...

Abilify Maintena- Aripiprazole Kit

ABILIFY MAINTENA (aripiprazole) is indicated for: Treatment of schizophrenia in adults [see Clinical Studies (14.1)] Maintenance monotherapy treatm...

Abilify Mycite- Aripiprazole Tablet

ABILIFY MYCITE, a drug-device combination product comprised of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor intended to track drug ingestion, is indicated for the: Treat...

Abilify- Aripiprazole Tablet

1.1 Schizophrenia ABILIFY is indicated for the treatment of schizophrenia. The efficacy of ABILIFY was established in four 4-6 week trials in adults and one 6-week trial in adolescents (13 to 17 years...

Abilify- Aripiprazole Tabletabilify- Aripiprazole Solutionabilify- Aripiprazole Tablet, Orally Disintegratingabilify- Aripiprazole Injection, Solution

ABILIFY Oral Tablets, Orally-Disintegrating Tablets, and Oral Solution are indicated for the treatment of: Schizophrenia [see Clinical Studies (14.1)] ...

Abiraterone Acetate Tablet

Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC)...

Abiraterone Acetate Tablet, Film Coated

Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC)...

Abiraterone Acetate Tablet, Film Coatedabiraterone Acetate Tablet

Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC)...

Abiraterone Acetate Tabletabiraterone Acetate Tablet, Film Coated

Abiraterone acetate is indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive pr...

Abiraterone Acetate- Abiraterone Tablet

Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC)...

Abiraterone- Abiraterone Acetate Tablet

Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC)...

Abraxane- Paclitaxel Injection, Powder, Lyophilized, For Suspension

1.1 Metastatic Breast Cancer ABRAXANE is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemothera...

Absorica- Isotretinoin Capsule

ABSORICA is a retinoid indicated for the treatment of severe recalcitrant nodular acne in patients 12 years of age and older. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The n...

Abstral Fentanyl- Fentanyl Citrate Tablet, Orally Disintegrating

ABSTRAL is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving, and who are tolerant to, around-the-clock opioid therapy for thei...

Abstral- Fentanyl Citrate Tablet

ABSTRAL (fentanyl) sublingual tablets are indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therap...

Abstral- Fentanyl Tablet

ABSTRAL (fentanyl) sublingual tablets are indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid thera...

Ac Control Daily Mask- Glycerin Solution

Indications & Usage: 1. After washing, prepare for mask treatment and tone skin by moisturizing your skin 2. Wear the mask, follow the cutting leave the eyes and mouth a space 3. Leave the mask 10...

Acam2000 (smallpox- Vaccinia Vaccine, Live Injection, Powder, Lyophilized, For Solution

ACAM2000 is indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection....

Acanya- Clindamycin Phosphate And Benzoyl Peroxide Gel

ACANYA Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older....

Acarbose Tablet

Acarbose is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus....

Accolate- Zafirlukast Tablet, Coated

ACCOLATE is indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older....

Accolate- Zafirlukast Tablet, Film Coated

ACCOLATE is indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older....

Accupril- Quinapril Hydrochloride Tablet, Film Coated

Hypertension ACCUPRIL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes a...

Accuretic- Quinapril Hydrochloride And Hydrochlorothiazide Tablet, Film Coated

Hypertension ACCURETIC is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes ...

Acd A- Citric Acid Monohydrate, Dextrose Monohydrate, And Trisodium Citrate Dihydrate Injection, Solution

ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is an anticoagulant for blood collection for use only with apheresis devices. [See Dosage and Administration (2).]...

Acd Solution Modified Solution

ACD solution modified is to be used in the labeling of red blood cells for intravenous administration with Cr-51 Sodium Chromate....

Acd-a- Anticoagulant Citrate Dextrose Solution A Solution

For use with automated pheresis equipment only. Use according to equipment manufacturer s instructions. This unit should be used for pheresis only....

Acebutolol Hydrochloride Capsule

Hypertension Acebutolol HCl capsules are indicated for the management of hypertension in adults. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diu...

Aceon- Perindopril Erbumine Tablet

1.1 Hypertension ACEON is indicated for the treatment of patients with essential hypertension. ACEON may be used alone or given with other classes of antihypertensives, especially thiazide diuretics....

Acetadote- Acetylcysteine Injection, Solution

ACETADOTE is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ing...

Acetaminophen And Codeine Phosphate Liquid

Acetaminophen and codeine phosphate oral solution is indicated for the management of mild to moderate pain where treatment with an opioid is appropriate and for which alternative treatments are inadeq...

Acetaminophen And Codeine Phosphate- Acetaminophen And Codeine Phosphate Solution

Acetaminophen and codeine phosphate oral solution is indicated for the relief of mild to moderate pain....

Acetaminophen And Codeine Phosphate- Acetaminophen And Codeine Phosphate Tablet

Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain....

Acetaminophen And Codeine- Acetaminophen And Codeine Phosphate Tablet

Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain....

Acetaminophen And Codeine- Acetaminophen And Codeine Phosphate Tabletacetaminophen And Codeine- Acetaminophen And Codeine Phosphate Tablet

Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain....

Acetaminophen And Codeine- Codeine Phosphate And Apap Tablet

Acetaminophen and Codeine Phosphate Tablets, USP are indicated for the relief of mild to moderately severe pain....

Acetaminophen, Butalbital And Caffeine Tablet

Butalbital, acetaminophen and caffeine tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this co...

Acetaminophen, Caffeine And Dihydrocodeine Bitartrate Tablet

Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate...

Acetaminophen, Caffeine And Dihydrocodeine Bitartrate- Acetaminophen, Caffeine And Dihydrocodeine Bitartrate Tablet

Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets are indicated for the relief of moderate to moderately severe pain....

Acetaminophen, Caffeine, Dihydrocodeine Bitartrate Capsule

Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate capsules are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequat...

Acetazolamide Capsule

For adjunctive treatment of: chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocula...

Acetazolamide Capsule, Extended Release

For adjunctive treatment of: chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intr...

Acetazolamide Injection, Powder, Lyophilized, For Solution

For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary gl...

Acetazolamide Tablet

For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary gl...

Acetazolamide- Acetazolamide Sodium Injection, Powder, Lyophilized, For Solution

For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary gl...

Acetylcysteine Inhalant

Acetylcysteine, administered orally, is indicated as an antidote to prevent or lessen hepatic injury which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen. It ...

Acetylcysteine Injection

Acetylcysteine Injection is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen. Overdose incide...

Acetylcysteine Injection, Solution

Acetylcysteine Injection is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen. Overdose incide...

Acetylcysteine Solution

Acetylcysteine, administered orally, is indicated as an antidote to prevent or lessen hepatic injury which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen. It ...

Aciphex Sprinkle- Rabeprazole Sodium Capsule, Delayed Release

ACIPHEX Sprinkle is indicated for treatment of Gastroesophageal Reflux Disease (GERD) in pediatric patients 1 to 11 years of age for up to 12 weeks....

Aciphex- Rabeprazole Sodium Tablet, Delayed Release

1.1 Healing of Erosive or Ulcerative GERD in Adults ACIPHEX delayed-release tablets are indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerativ...

Acitretin Capsule

Acitretin Capsules, USP are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, Acitretin Capsules, USP should be prescribed only...

Actemra- Tocilizumab Injection, Solution, Concentrateactemra- Tocilizumab Injection, Solutionactemra Actpen- Tocilizumab Injection, Solution

1.1 Rheumatoid Arthritis (RA) ACTEMRA (tocilizumab) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to on...

Acthar- Repository Corticotropin Injection

1.1 Infantile spasms Acthar Gel (repository corticotropin injection) is indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age. 1.2 Multiple Scl...

Acthib- Haemophilus Influenzae Type B Strain 1482 Capsular Polysaccharide Tetanus Toxoid Conjugate Antigen Kit

ActHIB is a vaccine indicated for the prevention of invasive disease caused by Haemophilus influenzae type b. ActHIB is approved for use in children 2 months through 5 years of age....

Acticlate Cap- Doxycycline Hyclate Capsule

1.1 Rickettsial Infections ACTICLATE and ACTICLATE CAP are indicated for treatment of Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsial pox, and tick fevers ca...

Acticlate- Doxycycline Hyclate Tablet, Coated

1.1 Rickettsial Infections ACTICLATE and ACTICLATE CAP are indicated for treatment of Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsial pox, and tick fevers ca...

Actigall- Ursodiol Capsule

Actigall is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of inc...

Actimmune- Interferon Gamma-1b Injection, Solution

ACTIMMUNE is indicated for reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD). ACTIMMUNE is indicated for delaying time to disease progressio...

Active Fe- .beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Iron Pentacarbonyl, Magnesium Oxide, Zinc Oxide, And Cupric Oxide Tablet

ACTIVE FE is an oral prescription multi-vitamin/multi-mineral dietary supplement for the use in improving the nutritional status of patients with iron deficiency. 1 1 This statement has not been ...

Activella- Estradiol And Norethindrone Acetate Tablet, Film Coated

1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause . 1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Limitation of Use When prescrib...

Activella- Estradiol/norethindrone Acetate Tablet, Film Coated

1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Limitation of Use When presc...

Actonel- Risedronate Sodium Tablet, Film Coated

1.1 Postmenopausal Osteoporosis ACTONEL is indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, ACTONEL reduc...

Actoplus Met Xr- Pioglitazone And Metformin Hydrochloride Tablet, Film Coated, Extended Release

ACTOPLUS MET XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both pioglitazone and metformin is appropriate [...

Actoplus Met- Pioglitazone And Metformin Hydrochloride Tablet, Film Coated

ACTOPLUS MET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both pioglitazone and metformin is appropriate [see...

Actoplus Met- Pioglitazone Hydrochloride And Metformin Hydrochloride Tablet, Film Coated

ACTOPLUS MET is a thiazolidinedione and biguanide combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already t...

Actos- Pioglitazone Hydrochloride Tablet

1.1 Monotherapy and Combination Therapy ACTOS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [s...

Actos- Pioglitazone Tablet

Monotherapy and Combination Therapy ACTOS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinica...

Acular Ls- Ketorolac Tromethamine Solution/ Drops

ACULAR LS ophthalmic solution is indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery....

Acular- Ketorolac Tromethamine Solution/ Drops

ACULAR ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. ACULAR ophthalmic solution is also indicated for the treatment of postop...

Acunistat-30- Lidocaine Hydrochloride, Ketorolac Tromethamine Kit

Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peri...

Acunistat-60- Lidocaine Hydrochloride, Ketorolac Tromethamine Kit

Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peri...

Acunivive 15- Ketorolac Tromethamine Injection, Solution

Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration cons...

Acunivive 30- Ketorolac Tromethamine Injection, Solution

Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration cons...

Acunivive 60- Ketorolac Tromethamine Injection, Solution

Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration cons...

Acunivive 90- Ketorolac Tromethamine Kit

Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration cons...

Acuvail- Ketorolac Tromethamine Solution/ Drops

ACUVAIL ophthalmic solution is indicated for the treatment of pain and inflammation following cataract surgery....

Acyclovir Capsule

Herpes Zoster Infections Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes Acyclovir is indicated for the treatment of initial episodes and the management o...

Acyclovir Capsuleacyclovir Tablet

Herpes Zoster Infections: Acyclovir capsules, USP and acyclovir tablets, USP are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir capsules, USP and acyclovir ta...

Acyclovir- Acyclovir Ointment

Acyclovir Ointment USP 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients....

Acyclovir- Acyclovir Sodium Injection, Solution

Herpes Simplex Infections in Immunocompromised Patients Acyclovir Sodium Injection is indicated for the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV-1 and HSV-2) in imm...

Aczone 7.5- Dapsone Gel

ACZONE (dapsone) Gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older....

Aczone- Dapsone Gel

ACZONE Gel, 5%, is indicated for the topical treatment of acne vulgaris....

Adacel Tdap (clostridium Tetani Toxoid Antigen (formaldehyde Inactivated), Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated), Bordetella Pertussis Toxoid Antigen (glutaraldehyde Inactivated), Bordetella Pertussis Filamentous Hemagglutinin Antigen- Formaldehyde Inactivated, Bordetella Pertussis Pertactin Antigen, And Bordetella Pertussis Fimbriae 2/3 Antigen Injection, Suspension

Adacel is a vaccine indicated for active booster immunization against tetanus, diphtheria and pertussis. Adacel is approved for use in individuals 10 through 64 years of age....

Adapalene And Benzoyl Peroxide Gel

Adapalene and benzoyl peroxide gel 0.1% / 2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older....

Adapalene Cream

Adapalene Cream, 0.1% is indicated for the topical treatment of acne vulgaris....

Adcetris- Brentuximab Vedotin Injection, Powder, Lyophilized, For Solution

1.1 Previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy ADCETRIS is indicated for the treatment of adult patients with previously untreated Stage II...

Adcirca- Tadalafil Tablet

1.1 Pulmonary Arterial Hypertension ADCIRCA is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness inc...

Adderall Xr- Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate Capsule, Extended Release

1.1 Attention Deficit Hyperactivity Disorder ADDERALL XR is indicated for the treatment of attention deficit hyperactivity disorder (ADHD). The efficacy of ADDERALL XR in the treatment of ADHD was ...

Adderall- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate Tablet

Adderall is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD) A diagnosis of Attention Deficit Hyperact...

Additive Formula 3- Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine Solution

Use only with Trima Accel red blood cell (RBC) apheresis collections. [See Dosage and Administration (2).]...

Addyi- Flibanserin Tablet, Film Coated

ADDYI is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or in...

Adefovir Dipivoxil Tablet

Adefovir dipivoxil tablets are indicated for the treatment of chronic hepatitis B in patients 12 years of age and older with evidence of active viral replication and either evidence of persistent elev...

Adempas- Riociguat Tablet, Film Coated

1.1 Chronic-Thromboembolic Pulmonary Hypertension Adempas is indicated for the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH), (WHO Group 4) after...

Adenocard- Adenosine Solution

Intravenous Adenocard (adenosine injection) is indicated for the following. Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypas...

Adenosine Injection

Adenosine Injection, USP is indicated for the following: Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Par...

Adenovirus Type 4 And Type 7 Vaccine, Live Kit

Adenovirus Type 4 and Type 7 Vaccine, Live, Oral is a vaccine indicated for active immunization for the prevention of febrile acute respiratory disease caused by Adenovirus Type 4 and Type 7. Adenovi...

Adhansia Xr- Methylphenidate Hydrochloride Capsule, Extended Release

ADHANSIA XRTM is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)]....

Adipex-p- Phentermine Hydrochloride Tablet

ADIPEX-P is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exog...

Adipex-p- Phentermine Hydrochloride Tabletadipex-p- Phentermine Hydrochloride Capsule

ADIPEX-P is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity...

Adlyxin- Lixisenatide Kitadlyxin- Lixisenatide Injection, Solution

ADLYXIN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: ADLYXIN has not been studied in patients with chron...

Admelog- Insulin Lispro Injection, Solution

ADMELOG is indicated to improve glycemic control in adults and pediatric patients 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus....

Adoxa- Doxycycline Capsule

To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline capsules and other antibacterial drugs, doxycycline capsules should be used only to treat or preven...

Adriamycin- Doxorubicin Hydrochloride Injection, Powder, Lyophilized, For Solution

1.1 Adjuvant Breast Cancer Adriamycin (DOXOrubicin HCl) for Injection, USP is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement...

Adriamycin- Doxorubicin Hydrochloride Injection, Solution

1.1 Adjuvant Breast Cancer Adriamycin (DOXOrubicin HCl) Injection, USP and Adriamycin (DOXOrubicin HCl) for Injection, USP is indicated as a component of multi-agent adjuvant chemotherapy for treatmen...

Adrucil- Fluorouracil Injection, Solution

Adrucil (fluorouracil injection) is indicated for the treatment of patients with: 1.1 Adenocarcinoma of the Colon and Rectum 1.2 Adenocarcinoma of the Breast 1.3 Gastric Adenocarcinoma 1.4 ...

Adult Infuvite Multiple Vitamins For Infusion- Asorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin 5-phosphate Sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol Acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin Injection, Solution

INFUVITE ADULT is indicated as a daily multivitamin maintenance supplement for adults and children aged 11 and older receiving parenteral nutrition. INFUVITE ADULT is also indicated in other situation...

Adult Infuvite Multiple Vitamins- Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 Phosphate Sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol Acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin Injection, Solution

INFUVITE ADULT is a combination of vitamins indicated for the prevention of vitamin deficiency in adults and children aged 11 and older receiving parenteral nutrition. The physician should not await t...

Advair Diskus- Fluticasone Propionate And Salmeterol Powder

1.1 Treatment of Asthma ADVAIR DISKUS is indicated for the twice-daily treatment of asthma in patients aged 4 years and older. ADVAIR DISKUS should be used for patients not adequately controlled on a...

Advair Hfa- Fluticasone Propionate And Salmeterol Xinafoate Aerosol, Metered

ADVAIR HFA is indicated for the twice-daily treatment of asthma in patients aged 12 years and older. ADVAIR HFA should be used for patients not adequately controlled on a long-term asthma control med...

Advanced Skin Lightening Cream- Hydroquinone Lotion

To gradually lighten hyperpigmentation of the skin such as age spots, liver spots, freckles or hyperpigmentation that can occur as a result of pregnancy or from the use of oral contraceptives....

Advate (antihemophilic Factor- Recombinant Kit

ADVATE [Antihemophilic Factor (Recombinant)] is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for: Control and pre...

Advicor- Niacin And Lovastatin Tablet, Extended Release

Therapy with lipid-altering agents should be only one component of multiple risk-factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercho...

Adynovate (antihemophilic Factor- Recombinant Pegylated Kit

ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is a human antihemophilic factor indicated in children and adults with hemophilia A (congenital factor VIII deficiency) for: On-demand treat...

Afinitor- Everolimus Tabletafinitor Disperz- Everolimus Tablet, For Suspension

1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer AFINITOR is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast canc...

Afirmelle- Levonorgestrel And Ethinyl Estradiol Kit

Afirmelle is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical ...

Afluria (influenza A Virus A/california/7/2009 X-181 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/texas/50/2012 X-223 (h3n2) Antigen (propiolactone Inactivated), And Influenza B Virus B/massachusetts/2/2012 Bx-51b Antigen- Propiolactone Inactivated Injection, Suspension

AFLURIA is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. AFLURIA is approved f...

Afrezza- Insulin Human Powder, Meteredafrezza- Insulin Human Kit

AFREZZA is a rapid acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Limitations of Use AFREZZA is not a substitute for long-acting insulin. A...

Africa Bird Homme All In One Fresh Controller- Dimethicone Cream

How to Use: After washing the face, gently spread over the entire face and neck....

Africa Bird Homme All In One Moisturizer- Glycerin Cream

How to Use: After washing the face, gently spread over the entire face and neck....

Agrylin- Anagrelide Hydrochloride Capsule

AGRYLIN is indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate a...

Airduo Respiclick- Fluticasone Propionate And Salmeterol Powder, Metered

AIRDUO RESPICLICK is indicated for the treatment of asthma in patients aged 12 years and older. AIRDUO RESPICLICK should be used for patients not adequately controlled on a long term asthma contro...

Ak-fluor- Fluorescein Sodium Injection

AK-FLUOR 10% (100 mg/mL) and 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature....

Akovaz- Ephedrine Sulfate Injection

AKOVAZ (ephedrine sulfate injection) is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia....

Aktipak- Erythromycin And Benzoyl Peroxide Gel

Aktipak is indicated for the topical treatment of acne vulgaris....

Akynzeo- Netupitant And Palonosetron Capsuleakynzeo- Fosnetupitant And Palonosetron Injection

AKYNZEO capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy,...

Albendazole 200 Mg- Albendazole Tablet, Film Coated

1.1 Neurocysticercosis Albendazole tablets are indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium. 1.2 Hy...

Albendazole Tablet

1.1 Neurocysticercosis Albendazole Tablets are indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium. 1.2 Hy...

Albendazole Tablet, Film Coated

1.1 Neurocysticercosis Albendazole is indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium. 1.2 Hydatid Dis...

Albenza- Albendazole Tablet, Film Coated

1.1 Neurocysticercosis ALBENZA is indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium. 1.2 Hydatid Disease...

Albuked (albumin- Human Solution

Emergency Treatment of Hypovolemic Shock Albuked 20 is hyperoncotic and on intravenous infusion will expand the plasma volume by an additional amount, three to four times the volume actually administe...

Albumin (human)- Albumin Human Solution

1.1 Hypovolemia ALBUMIN (HUMAN) 5% is indicated in the emergency treatment of hypovolemia with or without shock. Its effectiveness in reversing hypovolemia depends largely upon its ability to draw i...

Albuminar-25 (albumin- Human Solution

SHOCK Albumin is indicated in the emergency treatment of shock and in other similar conditions where the restoration of blood volume is urgent. If there has been considerable loss of red blood cells,...

Albuminex- Albumin Human Solution

1.1 Hypovolemia ALBUMINEX 25% is indicated for restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate e.g. hypovolem...

Alburx (albumin- Human Solution

General Principles17 Volume Deficit Since the oncotic pressure of AlbuRx 25, Albumin (Human) 25% solution is about four times higher than that of normal human serum, it will expand the plasma vol...

Albutein (albumin- Human Injection, Solution

1.1 Hypovolemia For restoration and maintenance of circulating blood volume where hypovolemia is demonstrated and colloid use is appropriate. When hypovolemia is long standing and hypoalbuminemia exi...

Albuterol Aerosol, Metered

Albuterol Inhalation Aerosol is indicated for the prevention and relief of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease, and for the prevention of exerc...

Albuterol Sulate Hfa- Albuterol Sulfate Aerosol, Metered

1.1 Bronchospasm Albuterol Sulfate HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients aged 4 years and older with reversible obstructive airway disease. ...

Albuterol- Albuterol Aerosol, Metered

Albuterol Inhalation Aerosol is indicated for the prevention and relief of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease, and for the prevention of exerc...

Albuterol- Albuterol Aerosol, Spray

Albuterol Inhalation Aerosol is indicated in patients 12 years of age and older, for the prevention and relief of bronchospasm in patients with reversible obstructive airway disease, and for the preve...

Albuterol- Albuterol Sulfate Tablet

Albuterol tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease....

Aldactazide- Spironolactone And Hydrochlorothiazide Tablet, Film Coated

Spironolactone, an ingredient of ALDACTAZIDE, has been shown to be a tumorigen in chronic toxicity studies in rats (see Precautions section). ALDACTAZIDE should be used only in those conditions descri...

Aldactone- Spironolactone Tablet, Film Coated

1.1 Heart Failure ALDACTONE is indicated for treatment of NYHA Class III IV heart failure and reduced ejection fraction to increase survival, manage edema, and reduce the need for hospitalization fo...

Aldara- Imiquimod Cream

1.1 Actinic Keratosis ALDARA Cream is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults. ...

Aldurazyme- Laronidase Injection, Solution, Concentrate

ALDURAZYME (laronidase) is indicated for patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and for patients with the Scheie form who have moderate to severe symptoms. ...

Alecensa- Alectinib Hydrochloride Capsule

ALECENSA is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test....

Alendronate Sodium Solution

1.1 Treatment of Osteoporosis in Postmenopausal Women Alendronate sodium is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, alendronate increases bone mas...

Alendronate Sodium Tablet

1.1 Treatment of Osteoporosis in Postmenopausal Women Alendronate sodium tablets are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, alendronate sodium ta...

Alendronate- Alendronate Sodium Tablet

1.1 Treatment of Osteoporosis in Postmenopausal Women Alendronate sodium tablets, USP are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, alendronate sodi...

Alfuzosin Hydrochloride Extended Release- Alfuzosin Hydrochloride Tablet

Alfuzosin hydrochloride is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. 1.1 Important Limitations of Use Alfuzosin hydrochloride is not indicated for the treat...

Alfuzosin Hydrochloride Tablet

Alfuzosin hydrochloride extended-release tablets, USP are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. 1.1 Important Limitations of Use Alfuzosin hydrochlorid...

Alfuzosin Hydrochloride Tablet, Extended Release

Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. 1.1 Important Limitations of Use Alfuzosin hydrochloride exten...

Alfuzosin Hydrochloride Tablet, Film Coated, Extended Release

Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. 1.1 Important Limitations of Use Alfuzosin hydrochloride exten...

Alfuzosin Hydrochloride- Alfuzosin Hydrochloride Tablet, Extended Release

Alfuzosin hydrochloride is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. 1.1 Important Limitations of Use Alfuzosin hydrochloride is not indicated for the treatm...

Alfuzosin Hydrochloride- Alfuzosin Tablet, Extended Release

Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. 1.1 Important Limitations of Use Alfuzosin hydrochloride exte...

Alimta- Pemetrexed Disodium Injection, Powder, Lyophilized, For Solution

1.1 Non-Squamous Non-Small Cell Lung Cancer (NSCLC) ALIMTA is indicated: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-sq...

Alinia- Nitazoxanide Tabletalinia- Nitazoxanide Powder, For Suspension

Diarrhea caused by Giardia lamblia or Cryptosporidium parvum: ALINIA for Oral Suspension (patients 1 year of age and older) and ALINIA Tablets (patients 12 years and older) are indicated for t...

Aliqopa- Copanlisib Injection, Powder, Lyophilized, For Solution

ALIQOPA is indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies. Accelerated approval was granted for this ...

Aliskiren Tablet, Film Coated

1.1 Hypertension Aliskiren tablets are indicated for the treatment of hypertension in adults to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular even...

Aliskiren- Aliskiren Hemifumarate Tablet, Film Coated

1.1 Hypertension Aliskiren is indicated for the treatment of hypertension in adults and children 6 years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal an...

Alkeran- Melphalan Hydrochloride Kit

ALKERAN for Injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate....

Alkeran- Melphalan Tablet, Film Coated

ALKERAN Tablets are indicated for the palliative treatment of multiple myeloma and for the palliation of non-resectable epithelial carcinoma of the ovary....

All In One Dual Mask- Glycerin Patch

Indications & Usage: 1. After washing, prepare for mask treatment and tone skin by moisturizing your skin 2. Wear the mask sheet (upper), follow the cutting leave the eyes a space - How to put ear...

All Purpose- Colloidal Oatmeal 1.5% Cream

Temporarily protects and helps relieve minor skin irritation and itching due to eczema, insect bites, rashes and dry skin....

Allergenic Extract

Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts...

Allergenic Extractsindividual Treatment Vial

When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to...

Allocord- Human Cord Blood Hematopoietic Progenitor Cell Injection, Solution

ALLOCORD, HPC (Hematopoietic Progenitor Cell), Cord Blood, is an allogeneic cord blood hematopoietic progenitor cell therapy indicated for use in unrelated donor hematopoietic progenitor stem cell tra...

Allopurinol Sodium Injection, Powder, Lyophilized, For Solution

Allopurinol Sodium for Injection is indicated for the management of patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and...

Allopurinol Tablet

THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol reduces serum and urinary uric acid concentrations. Its use should be individualized f...

Allopurinol Tabletallopurinol Tablet

THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol tablets USP reduces serum and urinary uric acid concentrations. Its use should be ind...

Allzital- Butalbital And Acetaminophen Tablet

ALLZITAL tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatme...

Almond Injection, Solutionapple Injection, Solutionapricot Injection, Solutionasparagus Injection, Solutionavocado Injection, Solutionbanana Injection, Solutionbarley Injection, Solutionkidney Bean Injection, Solutionstring Bean Injection, Solutionbeef Injection, Solutionbrazil Nut Injection, Solutionbroccoli Injection, Solutionbuckwheat Injection, Solutioncabbage Injection, Solutioncantaloupe Injection, Solution

These products are for diagnostic use only. Diagnostic allergenic extracts are indicated for use in skin testing to establish the clinical relevance of specific allergens to which the patient has been...

Almotriptan Malate Tablet, Film Coated

1.1 Acute Treatment of Migraine Attacks Adults Almotriptan malate tablets are indicated for the acute treatment of migraine attacks in patients with a history of migraine with or without aura. Adoles...

Almotriptan Malate- Almotriptan Tablet, Film Coated

1.1 Acute Treatment of Migraine Attacks Adults Almotriptan tablets (almotriptan malate) are indicated for the acute treatment of migraine attacks in patients with a history of migraine with or witho...

Almotriptan Tablet, Film Coated

1.1 Acute Treatment of Migraine Attacks Adults Almotriptan tablets, USP are indicated for the acute treatment of migraine attacks in patients with a history of migraine with or without aura. Adolesce...

Alocril- Nedocromil Sodium Solution/ Drops

ALOCRIL ophthalmic solution is indicated for the treatment of itching associated with allergic conjunctivitis....

Alodox- Doxycyline Hyclate Tablet

To reduce the development of drug-resistant bacteria and maintain the effectivenessof Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline HyclateTablets should be used only to treat...

Alogliptin And Metformin Hydrochloride Tablet, Film Coated

1.1 Monotherapy and Combination Therapy Alogliptin and metformin HCl tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellit...

Alogliptin And Pioglitazone- Alogliptin Benzoate And Pioglitazone Hydrochloride Tablet, Film Coated

1.1 Monotherapy and Combination Therapy Alogliptin and pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when tr...

Alogliptin Tablet, Film Coated

1.1 Monotherapy and Combination Therapy Alogliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (1...

Alomide- Lodoxamide Tromethamine Solution/ Drops

ALOMIDE (lodoxamide tromethamine ophthalmic solution) 0.1% is indicated in the treatment of the ocular disorders referred to by the terms vernal keratoconjunctivitis, vernal conjunctivitis, and vern...

Alora- Estradiol Transdermal System Patch

Alora is indicated in: Treatment of moderate to severe vasomotor symptoms associated with the menopause. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the me...

Alosetron Hydrochloride Tablet

Alosetron hydrochloride tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: chronic IBS symptoms (generally lasting 6 months or longer)...

Alosetron Hydrochloride Tablet, Film Coated

Alosetron hydrochloride tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: chronic IBS symptoms (generally lasting 6 months or longer), ...

Alosetron Hyochloride Tablet

Alosetron hydrochloride tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: chronic IBS symptoms (generally lasting 6 months or longer...

Aloxi- Palonosetron Hydrochloride Injection

1.1 Chemotherapy-Induced Nausea and Vomiting in Adults ALOXI is indicated for: Moderately emetogenic cancer chemotherapy -- prevention of acute and delayed nausea and vomiting associated with initial...

Alphanine Sd (coagulation Factor Ix- Human Kit

AlphaNine SD is indicated for the prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B. AlphaNine SD contains low, non-therapeutic levels of Factors II, VII, an...

Alprazolam Er- Alprazolam Tablet, Extended Release

Alprazolam extended-release tablets are indicated for the treatment of panic disorder, with or without agoraphobia. This claim is supported on the basis of two positive studies with alprazolam extende...

Alprazolam Extended Release- Alprazolam Tablet, Extended Release

Alprazolam extended-release tablets, USP are indicated for the treatment of panic disorder, with or without agoraphobia. This claim is supported on the basis of two positive studies with alprazolam ex...

Alprazolam Extended-release- Alprazolam Tablet, Extended Release

Alprazolam extended-release tablets are indicated for the treatment of panic disorder, with or without agoraphobia. This claim is supported on the basis of two positive studies with alprazolam extende...

Alprazolam Solution, Concentrate

Anxiety Disorders Alprazolam IntensolTM Oral Solution is indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III...

Alprazolam Tablet

Anxiety Disorders Alprazolam tablets are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of ...

Alprostadil Injection, Solution, Concentrate

Alprostadil injection USP is indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in n...

Altabax- Retapamulin Ointment

ALTABAX is indicated for use in adults and pediatric patients aged 9 months and older for the topical treatment of impetigo (up to 100 cm2 in total area in adults or 2% total body surface area in pe...

Altacaine- Tetracaine Hydrochloride Solution

For procedures in which a rapid and short acting topical ophthalmic anesthetic is indicated such as in tonometry, gonioscopy, removal of corneal foreign bodies, conjunctival scraping for diagnostic pu...

Altace- Ramipril Capsule

1.1 Hypertension ALTACE is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primaril...

Altafluor- Fluorescein Sodium And Benoxinate Hydrochloride Solution

Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%/0.4% is indicated for ophthalmic procedures requiring a disclosing agent in combination with a topical ophth...

Altavera- Levonorgestrel And Ethinyl Estradiol Kit

Altavera is indicated for use by females of reproductive potential to prevent pregnancy....

Altoprev- Lovastatin Tablet, Extended Release

Therapy with lipid-altering agents should be one component of multiple risk factor intervention in individuals who require modifications of their lipid profile. Drug therapy is recommended as an adjun...

Alunbrig- Brigatinib Tablet, Coated

ALUNBRIG is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib....

Alunbrig- Brigatinib Tablet, Film Coatedalunbrig- Brigatinib Kit

ALUNBRIG is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib....

Alyacen 1/35- Norethindrone And Ethinyl Estradiol Kit

ALYACEN 7/7/7 and ALYACEN 1/35 Tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are...

Alyacen 7/7/7- Norethindrone And Ethinyl Estradiol Kit

ALYACEN 7/7/7 and ALYACEN 1/35 Tabletsare indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Tabl...

Alyacen 7/7/7- Norethindrone And Ethinyl Estradiol Kitalyacen 1/35- Norethindrone And Ethinyl Estradiol Kit

ALYACEN 7/7/7 and ALYACEN 1/35 Tabletsare indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Tabl...

Alyq- Tadalafil Tablet, Film Coated

1.1 Pulmonary Arterial Hypertension ALYQ is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness includ...

Amabelz- Estradiol And Norethindrone Acetate Tablet

1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Limitation of Use When prescr...

Amantadine Capsule

Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules a...

Amantadine Hcl- Amantadine Hydrochloride Capsule

Amantadine Hydrochloride Capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine Hydrochloride Capsu...

Amantadine Hcl- Amantadine Hydrochloride Capsule, Liquid Filled

Amantadine Hydrochloride Capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine Hydrochloride Capsu...

Amantadine Hydrochloride Capsule

Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules a...

Amaryl- Glimepiride Tablet

AMARYL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1)]. Limitations of Use AMARYL should not be used...

Ambien Cr- Zolpidem Tartrate Tablet, Coated

Ambien CR (zolpidem tartrate extended-release tablets) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time afte...

Ambien- Zolpidem Tartrate Tablet, Film Coated

Ambien (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Ambien has been shown to decrease sleep latency for up to 35 days ...

Ambisome- Amphotericin B Injection, Powder, Lyophilized, For Solution

AmBisome is indicated for the following: Empirical therapy for presumed fungal infection in febrile, neutropenic patients. Treatment of Cryptococcal Meningitis in HIV-infected patients (see D...

Ambrisentan Tablet, Film Coated

Ambrisentan is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): To improve exercise ability and delay clinical worsening. Studies establishing effectiveness incl...

Ameluz- Aminolevulinic Acid Hydrochloride Gel

AMELUZ gel, in combination with photodynamic therapy (PDT) using BF-RhodoLED lamp, a narrowband, red light illumination source, is indicated for lesion-directed and field-directed treatment of act...

Amerge- Naratriptan Hydrochloride Tablet, Film Coated

AMERGE is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use Use only if a clear diagnosis of migraine has been established. If a patient has no resp...

American Cockroach Injection, Solution

Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic sympto...

Americana Whey Protein Supplement- Whey Protein Concentrated Powder

Americana Whey is a source of essential branched-chain amino acids (BCASS) leucine, isoleucine, and valine. Americana Whey helps forming blood vessels, supporting immune systems and regulating metabol...

Amethia Lo- Levonorgestrel/ethinyl Estradiol And Ethinyl Estradiol Kit

AMETHIATM Lo (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy....

Amethia- Ethinyl Estradiol And Levonorgestrel Kit

AMETHIA tablets are indicated for use by women to prevent pregnancy....

Amethyst- Levonorgestrel And Ethinyl Estradiol Tablet

Amethyst (levonorgestrel and ethinyl estradiol tablets, USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contrac...

Amicar- Aminocaproic Acid Solutionamicar- Aminocaproic Acid Tablet

AMICAR is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be requir...

Amicar- Aminocaproic Acid Tablet

AMICAR is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be requir...

Amidate- Etomidate Injection, Solution

AMIDATE is indicated by intravenous injection for the induction of general anesthesia. When considering use of AMIDATE, the usefulness of its hemodynamic properties (see CLINICAL PHARMACOLOGY) should...

Amidate- Etomidate Injection, Solutionamidate- Etomidate Injection, Solution

AMIDATE is indicated by intravenous injection for the induction of general anesthesia. When considering use of AMIDATE, the usefulness of its hemodynamic properties (see CLINICAL PHARMACOLOGY) should ...

Amiloride Hydrochloride And Hydrochlorothiazide Tablet

Amiloride hydrochloride and hydrochlorothiazide tablets are indicated in those patients with hypertension or with congestive heart failure who develop hypokalemia when thiazides or other kaliuretic ...

Amiloride Hydrochloride Tablet

Amiloride hydrochloride tablets are indicated as adjunctive treatment with thiazide diuretics or other kaliuretic-diuretic agents in congestive heart failure or hypertension to: a. help restore norma...

Amiloride Hydrocloride Tablet

Amiloride HCl is indicated as adjunctive treatment with thiazide diuretics or other kaliuretic-diuretic agents in congestive heart failure or hypertension to: a. help restore normal serum potassium l...

Aminocaproic Acid Injection, Solution

Aminocaproic Acid Injection is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, fresh whole blood transfusions, fibrinogen infusions, and other...

Aminocaproic Acid Solution

Aminocaproic acid oral solution is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergen...

Aminocaproic Acid Tablet

Aminocaproic Acid Tablets is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency mea...

Aminocaproic Acid Tabletaminocaproic Acid Syrup

Aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures ma...

Aminosyn Ii- Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyltyrosine, And Glycine Injection, Solution

Aminosyn II, Sulfite-Free, (an amino acid injection) infused with dextrose by peripheral vein infusion is indicated as a source of nitrogen in the nutritional support of patients with ad...

Aminosyn-pf- Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Glycine, Histidine, Proline, Serine, Taurine, And Tyrosine Injection, Solution

Aminosyn-PF 7%, Sulfite-Free, (an amino acid injection pediatric formula) is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN...

Amiodarone Hcl- Amiodarone Hydrochloride Tablet

Because of its life-threatening side effects and the substantial management difficulties associated with its use (see WARNINGS below), amiodarone is indicated only for the treatment...

Amiodarone Hydrochloride Injection

Amiodarone injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patient...

Amiodarone Hydrochloride Injection, Solution

Amiodarone Hydrochloride Injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (...

Amitiza- Lubiprostone Capsule, Gelatin Coated

Enter section text here 1.1 Chronic Idiopathic Constipation Amitiza is indicated for the treatment of chronic idiopathic constipation in adults. 1.2 Irritable Bowel Syndrome with Constipation ...

Amitriptyline Hydrochloride Tablet

For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states....

Amitriptyline Hydrochloride Tablet, Film Coated

For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states....

Amitriptyline Hydrochloride Tablet, Film Coatedamitriptyline Hydrochloride Tablet, Film Coated

For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states....

Amitriptyline Hydrochloride- Amitriptyline Hydrochloride Tablet

For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states....

Amlobenz Capsule

{template} 1.1 Hypertension Amlodipine besylate and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either...

Amlodipine And Atorvastatin Tablet, Film Coated

Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine 1.1 Hypertension Amlodipine is indicated for the tr...

Amlodipine And Benazepril Hydrochloride Capsule

1.1 Hypertension Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent....

Amlodipine And Olmesartan Medoxomil Tablet

Amlodipine and Olmesartan Medoxomil Tablets is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the ri...

Amlodipine And Olmesartan Medoxomil Tablet, Film Coated

Amlodipine and olmesartan medoxomil tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the r...

Amlodipine And Olmesartan Medoxomil- Amlodipine And Olmesartan Medoxomil Tablet, Film Coated

Amlodipine and olmesartan medoxomil tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the r...

Amlodipine And Olmesartan Medoxomil- Amlodipine Besylate And Olmesartan Medoxomil Tablet, Film Coated

Amlodipine and olmesartan medoxomil tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the r...

Amlodipine And Valsartan Tabletamlodipine And Valsartan Tablet

1.1 Hypertension Amlodipine and Valsartan Tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovasc...

Amlodipine And Valsartan- Amlodipine Besylate And Valsartan Tablet, Film Coated

1.1 Hypertension Amlodipine and valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfata...

Amlodipine Besylate And Atorvastatin Calcium Tablet, Film Coated

Amlodipine besylate and atorvastatin calcium tablets (amlodipine and atorvastatin) is indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine 1.1 Hy...

Amlodipine, Valsartan And Hydrochlorothiazide Tablet

Amlodipine, valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovas...

Amlodipine, Valsartan And Hydrochlorothiazide Tablet, Film Coated

Amlodipine, valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovas...

Amlodipine, Valsartan, Hydrochlorothiazide- Amlodipine Besylate Valsartan Hydrochlorothiazide Tablet, Film Coated

Amlodipine/valsartan/hydrochlorothiazide is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events,...

Amlodipine, Valsartan, Hydrochlorothiazide- Amlodipine Valsartan And Hydrochlorothiazide Tablet, Film Coated

Amlodipine, valsartan, hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascul...

Amlodipine- Amlodipine Besylate Tablet

1. Hypertension Amlodipine is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. 2. Coronary Artery Disease (CAD) Chronic St...

Ammonia N 13 Injection

Ammonia N 13 Injection, USP is indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in p...

Ammonia N 13 N 13- Ammonia N-13 Injection

Ammonia N 13 Injection, USP is indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in p...

Ammonia N 13- Ammonia N-13 Injection

Ammonia N 13 Injection is indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patien...

Ammonia N 13- Ammonia N-13 Injection, Solution

Ammonia N 13 Injection is indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patie...

Ammonia N 13- Nh3n13 Injection

Ammonia N 13 Injection USP is indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in pa...

Ammonul- Sodium Phenylacetate And Sodium Benzoate Injection, Solution, Concentrate

AMMONUL is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea ...

Amoxicillan And Clavulanate Potassium Tablet, Film Coated

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets, USP and other antibacterial drugs, amoxicillin and clavulanate pot...

Amoxicillan Capsule

Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY -lactamase-negative) strains of the designated microorganisms in the conditions listed below: Infections of the ear, ...

Amoxicillan Tablet

Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY -lactamase-negative) strains of the designated microorganisms in the conditions listed below: Infections of the ear, ...

Amoxicillin And Clavulanate Potassium Extended Release- Amoxicillin And Clavulanate Potassium Tablet, Film Coated, Extended Release

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Extended Release Tablets and other antibacterial drugs, Amoxicillin and Cla...

Amoxicillin And Clavulanate Potassium Powder, For Suspension

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension, USP and other antibacterial drugs, amoxicillin and cla...

Amoxicillin And Clavulanate Potassium- Amoxicillin And Clavulanate Potassium Powder, For Suspensionamoxicillin And Clavulanate Potassium- Amoxicillin And Clavulanate Potassium Tablet, Chewable

Amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) is indicated in the treatment of infections caused by susceptible strains of the...

Amoxicillin And Clavulanate Potassium- Amoxicillin And Clavulanate Potassium Suspension

Amoxicillin and clavulanate potassium for oral suspension, USP, 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. p...

Amoxicillin And Clavulanate Potassium- Amoxicillin And Clavulanate Potassium Tablet, Film Coated

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets USP, and other antibacterial drugs, amoxicillin and clavulanate pot...

Amoxicillin- Amoxicillin Capsule

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat or prevent infections that ar...

Amoxicillin- Amoxicillin Capsule

Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY -lactamase negative) strains of the designated microorganisms in the conditions listed below:Infections of the ear,...

Amoxicillin- Amoxicillin Capsuleamoxicillin- Amoxicillin Tablet, Film Coatedamoxicillin- Amoxicillin Tablet, Chewableamoxicillin- Amoxicillin Suspension

Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY -lactamase-negative) strains of the designated microorganisms in the conditions listed below: Infections of the ear, ...

Amoxicillin- Amoxicillin Powder, For Suspension For Suspension

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or...

Amoxicillin- Amoxicillin Tablet, Film Coated Tablet

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin tablets, USP and other antibacterial drugs, amoxicillin tablets, USP should be used only to treat inf...

Amphadase- Hyaluronidase Injection

1.1 Subcutaneous Fluid Administration Amphadase is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration. 1.2 Dispersion and Absorption of Injected Drugs ...

Amphotec- Amphotericin B Injection, Lipid Complex

AMPHOTEC is indicated for the treatment of invasive aspergillosis in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate in effective doses, and i...

Amphotericin B Injection, Powder, Lyophilized, For Solution

Amphotericin B for Injection USP should be administered primarily to patients with progressive, potentially life-threatening fungal infections. This potent drug should not be used to treat noninvasive...

Ampyra- Dalfampridine Tablet, Film Coated, Extended Release

AMPYRA is indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed [see Clinical Studies (14)]....

Amrix- Cyclobenzaprine Hydrochloride Capsule, Extended Release

AMRIX (cyclobenzaprine hydrochloride extended-release capsules) is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal cond...

Amyvid- Florbetapir F 18 Injection, Solution

Amyvid is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate -amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for A...

An Adc Face Up Special Program- Oatmeal Solution

Indications & usage:1. Open the wine colored pack to the dotted line(please be careful not to spill any of the liquid inside)2. Open the small transparent vial and pour it into the pack (please be...

An Adc Whitening Essence- Oatmeal Cream

Indications & usage:1. Apply a thin layer all over the face, being generous on the splotchy, discolored areas.2. Apply lightly in the morning and amply at night; your skin will feel very moisturiz...

Anagrelide Capsule

Anagrelide capsules are indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to...

Anagrelide Hydrochloride Capsule

Anagrelide capsules USP are indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis an...

Anascorp (centruroides (scorpion) Immune F(ab)2- Equine Injection, Powder, Lyophilized, For Solution

ANASCORP [Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection] is an equine-derived antivenom indicated for treatment of patients with clinical signs of scorpion envenomation....

Anastrozole Tablet

1.1 Adjuvant Treatment Anastrozole tablets are indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. 1.2 First-Line Treatment Anastrozole ta...

Anastrozole- Anastrozole Tablets Tablet

1.1 Adjuvant Treatment Anastrozole is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. 1.2 First-Line Treatment Anastrozole is indicated ...

Ancobon- Flucytosine Capsule

ANCOBON is indicated only in the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus. Candida: Septicemia, endocarditis and urinary system infections have been...

Androderm- Testosterone Patch

ANDRODERM is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): testic...

Androgel- Testosterone Gel

1.1 Testosterone Replacement Therapy AndroGel, an androgen, is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Prim...

Androxy- Fluoxymesterone Tablet

Males ANDROXY Tablets are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired) Testicu...

Anectine- Succinylcholine Chloride Injection, Solution

Succinylcholine chloride is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation....

Anesthesia S/i-40- Propofol, Isopropyl Alcohol Kit

DIPRIVAN Injectable Emulsion is an IV sedative-hypnotic agent that can be used as described in the table below. Safety, effectiveness and dosing guidelines for DIPRIVAN Injectable Emulsion ...

Anesthesia S/i-60- Propofol, Sterile Isopropyl Alcohol Kit

DIPRIVAN Injectable Emulsion is an IV sedative-hypnotic agent that can be used as described in the table below. Safety, effectiveness and dosing guidelines for DIPRIVAN Injectable Emulsion ...

Angeliq- Drospirenone And Estradiol Tablet, Film Coated

1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause Angeliq 0.25 mg drospirenone (DRSP)/0.5 mg estradiol (E2) is indicated for the treatment of moderate to severe vasomotor s...

Angiomax- Bivalirudin Injection

Angiomax is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced t...

Angiomax- Bivalirudin Injection, Powder, Lyophilized, For Solution

Angiomax is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced t...

Animal Allergens, Ap Horse Hair And Dander- Ap Horse Hair And Dander Injection, Solutionanimal Allergens, Ap Cattle Hair And Dander- Cattle Hair And Dander Injection, Solutionanimal Allergens, Ap Dog Hair And Dander Canis Spp- Animal Allergens, Dog Dander Canis Spp Injection, Solutionanimal Allergens, Dog Hair And Dander Canis Spp.- Dog Hair Canis Spp. Injection, Solutionanimal Allergens, Feather Mix- Feather Mix Injection, Solutionanimal Allergens, Guinea Pig Hair And Dander- Guinea Pig Hair And Dander Injection, Solutionfood - Animal Products And Poultry Products, Beef Bovine Spp.- Beef Bovine Spp. Injection, Solutionfood - Animal Products And Poultry Products, Chicken Meat Gallus Sp.- Chicken Meat Gallus Sp. Injection, Solution

20,21,22,23Allergenic extracts are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific environmental allergens. The sele...

Animal Allergens, Ap Horse Hair And Dander- Ap Horse Hair And Dander Injection, Solutionanimal Allergens, Ap Cattle Hair And Dander- Cattle Hair And Dander Injection, Solutionanimal Allergens, Ap Dog Hair And Dander Canis Spp- Animal Allergens, Dog Dander Canis Spp Injection, Solutionanimal Allergens, Dog Hair And Dander Canis Spp.- Dog Hair Canis Spp. Injection, Solutionanimal Allergens, Feather Mix- Feather Mix Injection, Solutionanimal Allergens, Guinea Pig Hair And Dander- Guinea Pig Hair And Dander Injection, Solutionfood - Animal Products And Poultry Products, Beef Bovine Spp.- Beef Bovine Spp. Injection, Solutionfood - Animal Products And Poultry Products, Chicken Meat Gallus Sp.- Chicken Meat Gallus Sp. Injection, Solutionfood - Animal Products And Poultry Products, Egg, White Gallus Sp.- Egg, White Gallus Sp. Injection, Solutionfood - Animal Products And Poultry Products, Egg, Yolk Gallus Sp.- Egg, Yolk Gallus Sp. Injection, Solutionfood - Animal Products And Poultry Products, Pork Sus Sp.- Pork Sus Sp. Injection, Solutionfood - Dairy Products, Casein, Cow Milk- Casein, Cow Milk Injection, Solutionfood - Dairy Products, Milk, Whole Cow- Milk, Whole Cow Injection, Solution

Certain diagnostics carry labeling which states Allergenic Extract for Diagnostic Use Only. Data to support the therapeutic use of products labeled with this statement have not been established. 14In ...

Animal Allergens, Ap Horse Hair And Dander- Ap Horse Hair And Dander Injection, Solutionanimal Allergens, Ap Cattle Hair And Dander- Cattle Hair And Dander Injection, Solutionanimal Allergens, Feather Mix- Feather Mix Injection, Solutioninsects Whole Body Cockroach Mix Injection, Solutioninsects Whole Body, Fire Ant ....... Injection, Solutionpollens - Weeds, Giant, Short, Western Ragweed Mix- Giant, Short, Western Ragweed Mix Injection, Solutionpollens - Weeds, Kochia Scoparia- Kochia Scoparia Injection, Solutionpollens - Weeds, Marshelder/poverty Mix Injection, Solutionpollens - Weeds, Weed Mix 2630- Weed Mix 2630 Injection, Solution

Certain diagnostics carry labeling which states Allergenic Extract for Diagnostic Use Only. Data to support the therapeutic use of products labeled with this statement have not been established.15 In ...

Annovera- Segesterone Acetate And Ethinyl Estradiol Ring

ANNOVERA is indicated for use by females of reproductive potential to prevent pregnancy. Limitation of Use: ANNOVERA has not been adequately studied in females with a BMI >29 kg/m2....

Annovera- Segesterone Acetate, Ethinyl Estradiol Ring

ANNOVERA is indicated for use by females of reproductive potential to prevent pregnancy. Limitation of Use: ANNOVERA has not been adequately studied in females with a BMI >29 kg/m ...

Anoro Ellipta- Umeclidinium Bromide And Vilanterol Trifenatate Powder

ANORO ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Important Limitations of Use ANORO ELLIPTA is NOT indicated for the relief of ac...

Antabuse- Disulfiram Tablet

Disulfiram Tablets USP are an aid in the management of selected chronic alcohol patients who want to remain in a state of enforced sobriety so that supportive and psychotherapeutic treatment may be ap...

Antara- Fenofibrate Capsule

1.1 Primary Hypercholesterolemia and Mixed Dyslipidemia Antara is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), t...

Antara- Fenofibrate Capsule

Treatment of Hypercholesterolemia Antara is indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides, and Apo B, and to increase HDL-C in adult patients with primary hy...

Anthim- Obiltoxaximab Solution

1.1 Inhalational Anthrax ANTHIM is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs. AN...

Antivenin- Latrodectus Mactans Kit

Antivenin (Latrodectus mactans) is used to treat patients with symptoms due to bites by the black widow spider (Latrodectus mactans). Early use of the Antivenin is emphasized for prompt relief. Local ...

Antizol- Fomepizole Injection

Antizol is indicated as an antidote for ethylene glycol (such as antifreeze) or methanol poisoning, or for use in suspected ethylene glycol or methanol ingestion, either alone or in combination wit...

Antizol- Fomepizole Injection, Solution

Antizol is indicated as an antidote for ethylene glycol (such as antifreeze) or methanol poisoning, or for use in suspected ethylene glycol or methanol ingestion, either alone or in combination with h...

Anzemet- Dolasetron Mesylate Tablet, Film Coated

ANZEMET Tablets are indicated for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy, including initial and repeat courses in adults and children 2 years ...

Apidra- Insulin Glulisine Injection, Solutionapidra Solostar- Insulin Glulisine Injection, Solution

APIDRA is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus....

Aplenzin Er- Bupropion Hydrobromide Tablet, Extended Release

Aplenzin (bupropion hydrobromide extended-release tablets) is indicated for the treatment of major depressive disorder. The efficacy of bupropion in the treatment of a major depressive episode was ...

Aplenzin- Bupropion Hydrobromide Tablet, Extended Release

1.1 Major Depressive Disorder APLENZIN (bupropion hydrobromide extended-release tablets) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistic...

Aplisol- Tuberculin Purified Protein Derivative Injection

Tuberculin PPD is indicated as an aid in the detection of infection with Mycobacterium tuberculosis. The standard tuberculin test employs the intradermal (Mantoux) test using a 5 TU dose of tuberculin...

Apokyn- Apomorphine Hydrochloride Injection

APOKYN (apomorphine hydrochloride injection) is indicated for the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) in patie...

Apple Injection, Solutionapricot Injection, Solutionavocado Injection, Solutionbanana Injection, Solutionblackberry Injection, Solutionblueberry- Blue Ridge Blueberry Injection, Solutioncantaloupe Injection, Solutioncherry Food (cherry) Injection, Solution Osage Orange Var Bois Darc Pollen (maclura Pomifera Pollen) Injection, Solution Lake Trout (trout) Injection, Solution Tuna Injection, Solution Turkey Food (turkey) Injection, Solution Black Walnut Food- Black Walnut Injection, Solution [allergy Laboratories, Inc.]osage Orange Var Bois Darc Pollen- Maclura Pomifera Pollen Injection, Solutionlake Trout- Trout Injection, Solutiontuna Injection, Solutionturkey Food- Turkey Injection, Solutionblack Walnut Food- Black Walnut Injection, Solution

Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergen...

Aprepitant Capsuleaprepitant Kit

1.1 Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Aprepitant capsules, in combination with other antiemetic agents, are indicated for the prevention of: acute and delayed nausea a...

Apri 28 Day- Desogestrel And Ethinyl Estradiol Kit

Apri (desogestrel and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are ...

Apri- Desogestrel And Ethinyl Estradiol Kit

Apri (desogestrel and ethinyl estradiol) Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highl...

Apriso- Mesalamine Capsule, Extended Release

APRISO capsules are indicated for the maintenance of remission of ulcerative colitis in patients 18 years of age and older....

Aptiom- Eslicarbazepine Acetate Tabletaptiom- Eslicarbazepine Acetate Kit

APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older....

Aptivus- Tipranavir Capsule, Liquid Filledaptivus- Tipranavir Solution

APTIVUS, co-administered with ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infected patients who are treatment-experienced and infected with HIV-1 strains resistant to mor...

Arabic Gum Injection, Solutionkaraya Gum Injection, Solutiontragacanth Gum Injection, Solutiondog Flea Injection, Solutioncat Flea Injection, Solution

Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts...

Aralast Np (alpha-1-proteinase Inhibitor- Human Kit

ARALAST NP is an Alpha1-Proteinase Inhibitor (Alpha1-PI) indicated for chronic augmentation therapy in adults with clinically evident emphysema due to severe congenital deficiency of Alpha1-PI (alpha1...

Aranesp- Darbepoetin Alfa Injection, Solutionaranesp- Darbepoetin Alfa Solution

1.1 Anemia Due to Chronic Kidney Disease Aranesp is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis...

Arava- Leflunomide Tablet, Film Coated

ARAVA is indicated for the treatment of adults with active rheumatoid arthritis (RA)....

Argatroban Injection

1.1 Heparin Induced Thrombocytopenia Argatroban Injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HI...

Argatroban Injection, Solution

1.1 Heparin-Induced Thrombocytopenia Argatroban Injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT). 1.2 ...

Argatroban Solution

1.1 Heparin-Induced Thrombocytopenia Argatroban Injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT). 1.2 Percutaneous Cor...

Aricept- Donepezil Hydrochloride Solution

ARICEPT is indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild to moderate Alzheimer's Disease, as well as in patients with severe A...

Aricept- Donepezil Hydrochloride Tablet, Film Coated

ARICEPT is indicated for the treatment of dementia of the Alzheimer s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer s disease....

Aricept- Donepezil Hydrochloride Tablet, Film Coatedaricept Odt- Donepezil Hydrochloride Tablet, Orally Disintegrating

ARICEPT is indicated for the treatment of dementia of the Alzheimer s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer s disease....

Aripiprazole Solution

Aripiprazole oral solution is indicated for the treatment of: Schizophrenia [see Clinical Studies (14.1)] Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder [see Clinica...

Aripiprazole- Aripiprazole Orally Disintegrating Tablet

Aripiprazole orally disintegrating tablets are indicated for the treatment of: Schizophrenia [see CLINICAL STUDIES (14.1)] Additional pediatric use information is approved for Otsuka America Ph...

Aripiprazole- Aripiprazole Tablet

Aripiprazole oral tablets are indicated for the treatment of: Schizophrenia [see CLINICAL STUDIES (14.1)]Additional pediatric use information is approved for Otsuka Americ...

Arixtra- Fondaparinux Sodium Injection, Solution

1.1 Prophylaxis of Deep Vein Thrombosis ARIXTRA is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): in patients undergoing hip fracture su...

Arranon- Nelarabine Injection

ARRANON is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has n...

Arthrotec- Diclofenac Sodium And Misoprostol Tablet, Film Coated

ARTHROTEC is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their comp...

Artiss Fibrin Sealant- Fibrinogen Human, Human Thrombin Solution

ARTISS is a fibrin sealant indicated to: Adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to 1 year of...

Arzerra- Ofatumumab Injection, Solution

Chronic Lymphocytic Leukemia (CLL) ARZERRA (ofatumumab) is indicated: in combination with chlorambucil, for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy...

Asacol Hd- Mesalamine Tablet, Delayed Release

Asacol HD is indicated for the treatment of moderately active ulcerative colitis in adults. Limitations of Use:Safety and effectiveness of Asacol HD beyond 6 weeks have not been established....

Asacol- Mesalamine Tablet, Delayed Release

Asacol tablets are indicated for the treatment of mildly to moderately active ulcerative colitis and for the maintenance of remission of ulcerative colitis....

Asceniv- Human Immunoglobulin G Liquid

ASCENIV (immune globulin intravenous, human slra) is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI) in adults a...

Asclera- Polidocanol Injection, Solution

Asclera (polidocanol) is indicated to sclerose uncomplicated spider veins (varicose veins 1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower e...

Ascomp With Codeine- Butalbital, Aspirin, Cafeine, And Codeine Phosphate Capsule

ASCOMP with CODEINE is a combination of butalbital, a barbiturate, aspirin, a nonsteroidal anti-inflammatory drug, caffeine, a methylxanthine, and codeine phosphate, an opioid agonist, and is indicate...

Ascomp With Codeine- Butalbital, Aspirin, Caffeine And Codeine Phosphate Capsule

ASCOMP with Codeine is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when non-opioid analgesic and alternative treatments are inadequate. Limitatio...

Ascor- Ascorbic Acid Injection

ASCOR is indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients, age 5 months and older, for whom oral administration is not possible, insuffici...

Ascorbic Acid Injection, Solution

Ascorbic acid is recommended for the prevention and treatment of scurvy. Its parenteral administration is desirable for patients with an acute deficiency or for those whose absorption of orally ingest...

Ash Pollen Mix- Fraxinus Pennsylvanica, Fraxinus Americana Solutionbirch Pollen Mix- Betula Lenta, Betula Nigra And Betula Populifolia Solutionpine Pollen Mix- Pinus Taeda, Pinus Strobus And Pinus Echinata Solution11 Tree Pollen Mix (fagus Grandifolia, Platanus Occidentalis, Ulmus Americana, Juglans Nigra, Salix Nigra, Populus Deltoides, Que ....... Pollen Mix- Acer Saccharum And Acer Negundo Solutioneastern 7 Tree Pollen Mix- Ulmus Americana, Fagus Grandifolia, Populus Deltoides, Quercus Rubra, Betula Nigra, Carya Ovata And Fraxinus Americana Solutioneastern 8 Tree Pollen Mix- Ulmus Americana, Fagus Grandifolia, Populus Deltoides, Quercus Rubra, Betula Nigra, Carya Ovata, Fraxinus Americana And Acer Saccharum Solution

Non-Standardized Allergenic Extracts are indicated for: Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens. Immunotherapy ...

Ashlyna- Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol Kit

Ashlynais indicated for use by women to prevent pregnancy....

Asparlas- Calaspargase Pegol Injection, Solution

1.1 Acute Lymphoblastic Leukemia ASPARLAS is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients ...

Aspergillus Fumigatus Injection, Solutionalternaria Alternata Injection, Solutionaspergillus Flavus Injection, Solutionaspergillus Repens Injection, Solutionaspergillus Niger Injection, Solutionaspergillus Terreus Injection, Solutionbotrytis Cinerea Injection, Solution.......ction, Solutionoat Smut Injection, Solutionwheat Smut Injection, Solutionwheat Bunt Injection, Solutionwheat Stem Rust Injection, Solutioncurvularia Inequalis Injection, Solutionfusarium Compactum Injection, Solutionphoma Glomerata Injection, Solution

Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts...

Aspirin And Omeprazole Delayed-release Tab- Aspirin And Omeprazole Tablet, Film Coated

aspirin and omeprazole delayed-release tablets, a combination of aspirin and omeprazole, is indicated for patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular ev...

Astagraf Xl- Tacrolimus Extended-release Capsules Capsule, Coated, Extended Release

ASTAGRAF XL is indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants in adult and pediatric patients who can swallow capsules in...

Astelin- Azelastine Hydrochloride Spray, Metered

Astelin Nasal Spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis such as rhinorrhea, sneezing, and nasal pruritus in adults and children 5 years and older, and for th...

Atacand Hct- Candesartan Cilexetil And Hydrochlorothiazide Tablet

ATACAND HCT is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION)....

Atacand Hct- Candesartan Cilexetil And Hydrochlorothiazide Tabletatacand Hct- Candesartan Cilexetil Hydrochlorothiazide Tablet

ATACAND HCT is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myoca...

Atazanavir Capsule, Gelatin Coated

Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 6 years and older weighing at least 15 kg. Limitations of Use: Ataz...

Atazanavir Sulfate Capsule

Atazanavir sulfate capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 6 years and older weighing at least 15 kg. Limitations of Us...

Atazanavir Sulfate- Atazanavir Capsule

Atazanavir capsule is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 6 years and older weighing at least 15 kg. Limitations of Use: Ataz...

Atenolol And Chlorthalidone Tablet

Atenolol and chlorthalidone tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, prim...

Atenolol- Atenolol Tablet

Hypertension Atenolol is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic. Angina Pe...

Atenolol- Atenolol Tablet

Hypertension Atenolol tablets are indicated in the management of hypertension. They may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic. A...

Atenolol- Atenolol Tablet

Hypertension Atenolol is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic. Angina Pe...

Atgam- Equine Thymocyte Immune Globulin Injection, Solution

1.1 Renal Allograft Rejection Renal transplant rejection: ATGAM is indicated for the management of allograft rejection in renal transplant patients; when administered with conventional therapy at th...

Atnaa Atropine And Pralidoxime Chloride Auto-injector- Atropine And Pralidoxime Chloride Kit

The ATNAA is indicated for the treatment of poisoning by susceptible organophosphorous nerve agents having anticholinesterase activity....

Atomoxetine Capsule

1.1 Attention-Deficit/Hyperactivity Disorder (ADHD) Atomoxetine capsules are indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). The efficacy of atomoxetine capsules was es...

Atomoxetine Hydrochloride Capsule

1.1 Attention-Deficit/Hyperactivity Disorder (ADHD) Atomoxetine capsules are indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). The efficacy of atomoxetine capsules was...

Atomoxetine- Atomoxetine Hydrochloride Capsule

1.1 Attention-Deficit/Hyperactivity Disorder (ADHD) Atomoxetine capsules are indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). The efficacy of atomoxetine capsules was ...

Atorvastatin Calcium Tablet

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercho...

Atorvastatin Calcium- Atorvastatin Calcium Propylene Glycol Solvate Tablet, Film Coated

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercho...

Atorvastatin Calcium- Atorvastatin Calcium Tablet, Film Coated

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercho...

Atorvastatin Calcium- Atorvastatin Calcium, Film Coated Tablet

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercho...

Atovaquone And Proguanil Hcl- Atovaquone And Proguanil Hydrochloride Tablet, Film Coated

1.1 Prevention of Malaria Atovaquone and Proguanil Hydrochloride tablets are indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resista...

Atovaquone And Proguanil Hydrochloride Tablet

Prevention of Malaria: Atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of P. falciparum malaria, including in areas where chloroquine resistance has been reported (see...

Atovaquone And Proguanil Hydrochloride Tablet, Film Coated

1.1 Prevention of Malaria Atovaquone and proguanil hydrochloride tabletsare indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been re...

Atovaquone And Proguanil Hydrochloride Tablet, Film Coatedatovaquone And Proguanil Hydrochloride Pediatric Tablet, Film Coated

1.1 Prevention of Malaria Atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been r...

Atovaquone Oral Suspension- Atovaquone Suspension

1.1 Prevention of Pneumocystis jirovecii Pneumonia Atovaquone oral suspension is indicated for the prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents (aged 13 years and old...

Atracurium Besylate Injection, Solution

Atracurium Besylate Injection, USP is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical venti...

Atridox- Doxycycline Hyclate Kit

ATRIDOX is indicated for use in the treatment of chronic adult periodontitis for a gain in clinical attachment, reduction in probing depth, and reduction in bleeding on probing....

Atripla Access- Efavirenz, Emtricitabine, And Tenofovir Disoproxil Fumarate Tablet, Film Coated

ATRIPLA is indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg....

Atripla- Efavirenz, Emtricitabine, And Tenofovir Disoproxil Fumarate Tablet, Film Coated

ATRIPLA is indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg....

Atropen Auto-injector- Atropine Injection

The ATROPEN Auto-Injector is indicated for the treatment of poisoning by susceptible organophosphorous nerve agents having cholinesterase activity as well as organophosphorous or carbamate insectici...

Atropine Sulfate Injection

Atropine sulfate is given parenterally as a preanesthetic medication to decrease salivation and bronchial secretions. It is useful in pylorospasm and other spastic conditions of the gastrointestinal t...

Atropine Sulfate Injection, Solution

Atropine is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus, carbamate, or muscarin...

Atropine Sulfate- Atropine Sulfate Injection

Atropine Sulfate Injection, USP, may be given parenterally as a pre-anesthetic medication in surgical patients to reduce salivation and bronchial secretions. It may also be used to suppress vagal acti...

Atropine Sulfate- Atropine Sulfate Injection, Solution

Atropine Sulfate Injection, USP, is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus ...

Atropine- Atropine Sulfate Solution/ Drops

Atropine Sulfate Ophthalmic Solution, USP 1% is indicated for: 1.1 Cycloplegia 1.2 Mydriasis 1.3 Penalization of the healthy eye in the treatment of amblyopia...

Atryn (antithrombin- Recombinant Injection, Powder, Lyophilized, For Solution

ATryn is a recombinant antithrombin indicated for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients1. It is not indicated for treat...

Atryn- Antithrombin Recombinant Injection, Powder, Lyophilized, For Solution

ATryn is a recombinant antithrombin indicated for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients1. It is not indicated for treat...

Aubagio- Teriflunomide Tablet, Film Coated

AUBAGIO is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, ...

Aubra Eq- Levonorgestrel And Ethinyl Estradiol Kit

Aubra EQ is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical a...

Aubra- Levonorgestrel And Ethinyl Estradiol Kit

Aubra is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical acci...

Aunt Ks- Oatmeal, Colloidal Powderaunt Ks- Oatmeal Colloidal Powderaunt Ks- Oatmeal, Collodial Powder

Uses: Helps treat and prevent diaper rash...

Auryxia- Ferric Citrate Tablet, Coated

1.1 Hyperphosphatemia in Chronic Kidney Disease on Dialysis Auryxia is indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis. 1.2 Iron Defic...

Av-phos 250 Neutral- Sodium Phosphate, Dibasic, Anhydrous, Potassium Phosphate, Monobasic, And Sodium Phosphate, Monobasic, Monohydrate Tablet

As a phosphorus supplement, each tablet supplies 25% of the U.S. Recommended Daily Allowance (U.S. RDA) of phosphorus for adults and children over 4 years of age. Av-Phos 250 Neutral increases urinary...

Avalide- Irbesartan And Hydrochlorothiazide Tablet, Film Coated

AVALIDE (irbesartan-hydrochlorothiazide) tablets are indicated for the treatment of hypertension. AVALIDE may be used in patients whose blood pressure is not adequately controlled on monotherapy. AV...

Avalide- Irbesartan And Hydrochlorothiazide Tabletavalide- Irbesartan And Hydrochlorothiazide Tablet, Film Coated

AVALIDE (irbesartan-hydrochlorothiazide) Tablets is indicated for the treatment of hypertension. AVALIDE may be used in patients whose blood pressure is not adequately controlled on monotherapy. A...

Avandamet- Rosiglitazone Maleate And Metformin Hydrochloride Tablet, Film Coated

After consultation with a healthcare professional who has considered and advised the patient of the risks and benefits of rosiglitazone, AVANDAMET is indicated as an adjunct to diet and exercise to ...

Avandia 2mg- Rosiglitazone Maleate Tablet, Film Coatedavandia 4mg- Rosiglitazone Maleate Tablet, Film Coated

AVANDIA is a thiazolidinedione antidiabetic agent indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use: ...

Avandia- Rosiglitazone Maleate Tablet, Film Coated

1.1 Monotherapy and Combination TherapyAVANDIA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 1.2 Important Limitations of Use...

Avastin- Bevacizumab Injection, Solution

1.1 Metastatic Colorectal Cancer Avastin, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first-or second-line treatment of patients with metastatic colorectal c...

Aveed- Testosterone Undecanoate Injection

Aveed is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired...

Avelox- Moxifloxacin Hydrochloride Injection, Solutionavelox- Moxifloxacin Hydrochloride Tablet, Film Coated

1.1 Community Acquired Pneumonia AVELOX is indicated in adult patients for the treatment of Community Acquired Pneumonia caused by susceptible isolates of Streptococcus pneumoniae (including multi-dr...

Avelox- Moxifloxacin Hydrochloride Tablet, Film Coated

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVELOX and other antibacterial drugs, AVELOX should be used only to treat or prevent infections that are proven o...

Averteax- Benzyl Alcohol Cream

Indications are for pain and itching associated with fever blisters and cold sores. For the temporary Relief of Pain and itching associated with fever blisters and cold sores....

Aviane 28 Day- Levonorgestrel And Ethinyl Estradiol Kit

Aviane is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical acc...

Aviane- Levonorgestrel And Ethinyl Estradiol Kit

Aviane (levonorgestrel and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives a...

Avodart- Dutasteride Capsule, Liquid Filled

1.1 Monotherapy AVODART (dutasteride) soft gelatin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: improve sympt...

Avonex- Interferon Beta-1a Kitavonex Pen- Interferon Beta-1a Injection, Solutionavonex- Interferon Beta-1a Injection, Powder, Lyophilized, For Solution

AVONEX is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in ...

Avycaz- Ceftazidime, Avibactam Powder, For Solution

1.1 Complicated Intra-abdominal Infections (cIAI) AVYCAZ (ceftazidime and avibactam) in combination with metronidazole, is indicated for the treatment of complicated intra-abdominal i...

Axert- Almotriptan Malate Tablet, Coated

1.1 Acute Treatment of Migraine Attacks Adults AXERT (almotriptan malate) is indicated for the acute treatment of migraine attacks in patients with a history of migraine with or without aura. A...

Axiron- Testosterone Solution

AXIRON is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): te...

Axumin- Fluciclovine F-18 Injection, Solution

Axumin is indicated for positron emission tomography (PET) in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment....

Ayuna- Levonorgestrel And Ethinyl Estradiol Kit

Ayuna is indicated for use by females of reproductive potential to prevent pregnancy....

Azacitidine Azacitidine- Azacitidine Injection, Powder, Lyophilized, For Solution

1.1 Myelodysplastic Syndromes (MDS) Azacitidine for injection is indicated for treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anem...

Azacitidine For- Azacitidine Injection, Powder, Lyophilized, For Solution

1.1 Myelodysplastic Syndromes (MDS) Azacitidine for injection is indicated for treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anem...

Azacitidine Injection, Powder, Lyophilized, For Solution

1.1 Myelodysplastic Syndromes (MDS) Azacitidine for Injection is indicated for treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory an...

Azactam- Aztreonam Injection, Powder, For Solution

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AZACTAM (aztreonam for injection, USP) and other antibacterial drugs, AZACTAM should be used only to treat or pre...

Azasan- Azathioprine Tablet

AZASAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms. Ren...

Azasite- Azithromycin Monohydrate Solution/ Drops

AzaSite is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms: CDC coryneform group G* Haemophilus influenzae Staph...

Azathioprine Sodium Injection, Powder, Lyophilized, For Solution

Azathioprine Sodium for Injection, USP is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis ...

Azathioprine Tablet

Azathioprine tablets are indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs an...

Azathioprine- Azathioprine Tablet

Azathioprine tablets are indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs an...

Azelaic Acid Gel

Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Although some reduction of erythema which was present in patients with pa...

Azelaic Acid Gel- Azelaic Acid Gel

Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Although some reduction of erythema which was present in patients with pa...

Azelastine Hydrochloride Spray, Metered

Azelastine hydrochloride nasal solution is indicated for the treatment of the symptoms of seasonal allergic rhinitis such as rhinorrhea, sneezing, and nasal pruritus in adults and children 5 years and...

Azelex- Azelaic Acid Cream

AZELEX cream is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris....

Azilect- Rasagiline Mesylate Tablet

AZILECT (rasagiline tablets) is indicated for the treatment of Parkinson s disease (PD)....

Azithromycin Dihydrate Tablet, Film Coated

Azithromycin Tablets, USP are indicated for the treatment of patients with mild to moderate infections (pneumonia: see WARNINGS) caused by susceptible strains of the designated microorgan...

Azithromycin Dihydrate- Azithromycin Tablet, Film Coated

Azithromycin tablets, are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the ...

Azithromycin For Suspension

Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific c...

Azithromycin Injection, Powder, Lyophilized, For Solution

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AZITHROMYCIN and other antibacterial drugs, AZITHROMYCIN should be used only to treat infections that are proven ...

Azithromycin Monohydrate Tablet

Azithromycin tablets are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the s...

Azithromycin- Azithromycin Anhydrous Tablet, Film Coated

Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific c...

Azithromycin- Azithromycin Dihydrate Injection, Powder, Lyophilized, For Solution

Azithromycin for Injection is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions li...

Azithromycin- Azithromycin For Injection Injection, Powder, Lyophilized, For Solution Injection

Azithromycin for injection is indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below. As re...

Azithromycin- Azithromycin Monohydrate Injection, Powder, Lyophilized, For Solution

Azithromycin for injection is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions li...

Azithromycin- Azithromycin Monohydrate Powder, For Suspension

Azithromycin is indicated for the treatment of patients with mild to moderate infections (pneumonia: see WARNINGS) caused by susceptible strains of the designated microorganisms in the specific cond...

Azithromycin- Azithromycin Monohydrate Tablet, Film Coated

Azithromycin tablets are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the s...

Azithromycin- Azithromycin Tablet, Film Coated

Azithromycin tablets are indicated for the treatment of patients with mild to moderate infections (pneumonia: see WARNINGS) caused by susceptible strains of the designated microorganisms in the specif...

Aztreonam Injection, Powder, Lyophilized, For Solution

To reduce the development of drug-resistant bacteria and maintain the effectiveness of aztreonam for injection, USP and other antibacterial drugs, aztreonam for injection should be used only to treat ...

Azulfidine En-tabs- Sulfasalazine Tablet, Delayed Release

AZULFIDINE EN-tabs Tablets are indicated: a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; b) for the prolongation of the remission ...

Azulfidine- Sulfasalazine Tablet

AZULFIDINE Tablets are indicated: a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and b) for the prolongation of the remission peri...

Azurette- Desogestrel/ethinyl Estradiol And Ethinyl Estradiol Kit

Azurette (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral cont...

B

B-12 Compliance- Cyanocobalamin, Isopropyl Alcohol Kit

Cyanocobalamin is indicated for Vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions: Addisonian (pernicious) anemia Gastrointestinal pathology, dysfu...

Babybig- Human Botulinum Neurotoxin A/b Immune Globulin Injection, Powder, Lyophilized, For Solution

BabyBIG , Botulism Immune Globulin Intravenous (Human), is indicated for the treatment of infant botulism caused by toxin type A or B in patients below one year of age....

Baclofen (intrathecal)- Baclofen Injection

Baclofen injection (intrathecal) is indicated for use in the management of severe spasticity. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long ...

Baclofen Injection

Baclofen injection is indicated for use in the management of severe spasticity in adult and pediatric patients age 4 years and above. Patients should first respond to a screening dose of intrathecal b...

Baclofen Injection, Solution

Baclofen injection is indicated for use in the management of severe spasticity in adult and pediatric patients age 4 years and above. Patients should first respond to a screening dose of intrathecal ...

Baclofen Tablet

Baclofen is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular ri...

Baclofen- Baclofen Tablet

Baclofen is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular ri...

Bactrim Ds- Sulfamethoxazole And Trimethoprim Tablet

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bactrim (sulfamethoxazole and trimethoprim) tablets and other antibacterial drugs, Bactrim (sulfamethoxazole and ...

Bactrim Ds- Sulfamethoxazole And Trimethoprim Tabletbactrim- Sulfamethoxazole And Trimethoprim Tablet

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bactrim (sulfamethoxazole and trimethoprim) tablets and other antibacterial drugs, Bactrim (sulfamethoxazole and ...

Bactroban- Mupirocin Calcium Cream

BACTROBAN cream is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible isolates of Staphylococcus aureus (S. au...

Bactroban- Mupirocin Calcium Ointment

BACTROBAN nasal ointment is indicated for the eradication of nasal colonization with methicillin resistant Staphylococcus aureus (MRSA) in adult and pediatric patients (aged 12 years and older) an...

Balanced Salt- Calcium Chloride, Magnesium Chloride, Potassium Chloride, Sodium Acetate, Sodium Chloride, Sodium Citrate Solution

For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes....

Balanced Salt- Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, And Sodium Citrate Solution

For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes....

Balcoltra- Levonorgestrel And Ethinyl Estradiol Kit

Balcoltra is indicated for use by females of reproductive potential to prevent pregnancy....

Balsalazide Disodium Capsule

Balsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. Safety and effectiveness of balsalazide beyond 8 w...

Baqsimi- Glucagon Powder

BAQSIMI is indicated for the treatment of severe hypoglycemia in patients with diabetes ages 4 years and above....

Basaglar- Insulin Glargine Injection, Solution

BASAGLAR is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Limitations of Use BASAGLAR is not re...

Bavencio- Avelumab Injection, Solution, Concentrate

1.1 Metastatic Merkel Cell Carcinoma BAVENCIO (avelumab) is indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication...

Baxdela- Delafloxacin Meglumine Tabletbaxdela- Delafloxacin Meglumine Injection, Powder, Lyophilized, For Solution

1.1 Acute Bacterial Skin and Skin Structure Infections BAXDELA is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of...

Bcg Vaccine- Bacillus Calmette-guerin Substrain Tice Live Antigen Injection, Powder, Lyophilized, For Solution

BCG VACCINE (TICE strain) is indicated for the prevention of tuberculosis in persons not previously infected with M. tuberculosis who are at high risk for exposure. As with any vaccine, immunization...

Bekyree- Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol Kit

Bekyree (desogestrel and ethinyl estradiol tablets USP and ethinyl estradiol tablets USP) are indicated for the prevention of pregnancy in women who elect to use this product as a method of contracept...

Belbuca- Buprenorphine Hydrochloride Film, Soluble

BELBUCA is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations o...

Beleodaq- Belinostat Injection, Powder, Lyophilized, For Solution

Beleodaq is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate a...

Belrapzo- Bendamustine Hydrochloride Injection

1.1 Chronic Lymphocytic Leukemia (CLL) BELRAPZO is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not ...

Belsomra- Suvorexant Tablet, Film Coated

BELSOMRA (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance....

Belviq Xr Extended Release Extended Release- Lorcaserin Hydrochloride Tablet, Film Coated, Extended Release

BELVIQ XR (lorcaserin hydrochloride) extended-release tablet is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients wit...

Belviq- Lorcaserin Hydrochloride Hemihydrate Tabletbelviq Xr- Lorcaserin Hydrochloride Hemihydrate Tablet, Film Coated, Extended Release

BELVIQ/BELVIQ XR is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of: ...

Benazepril Hydrochloride And Hydrochlorothiazide Tablet

Benazepril hydrochloride and hydrochlorothiazide tablets are indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension (see DOS...

Bendamustine Hydrochloride Injection

1.1 Chronic Lymphocytic Leukemia (CLL) Bendamustine Hydrochloride Injection is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies othe...

Bendeka- Bendamustine Hydrochloride Injection, Solution

1.1 Chronic Lymphocytic Leukemia (CLL) BENDEKA (bendamustine hydrochloride) injection is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line t...

Benefix (coagulation Factor Ix- Recombinant Kit

BeneFIX , Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adult and pediatric patients with hemophilia B (congenital factor IX deficiency or Christmas disease) f...

Benlysta- Belimumab Injection, Powder, Lyophilized, For Solutionbenlysta- Belimumab Solution

BENLYSTA (belimumab) is indicated for the treatment of patients aged 5 years and older with active, autoantibody positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. Limi...

Benzaclin- Clindamycin Phosphate And Benzoyl Peroxide Gel

BenzaClin Topical Gel is indicated for the topical treatment of acne vulgaris....

Benzamycin- Erythromycin And Benzoyl Peroxide Kit

Benzamycin Topical Gel is indicated for the topical treatment of acne vulgaris....

Benzodox 30 Kit- Doxycycline Tablets And Advanced Acne Wash Kit

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline tablets and other antibacterial drugs, doxycycline tablets should be used only to treat or prevent infect...

Benzodox 60 Kit- Doxycycline Tablets And Advanced Acne Wash Kit

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline tablets and other antibacterial drugs, doxycycline tablets should be used only to treat or prevent infect...

Benzonatate Capsule

Benzonatate is indicated for the symptomatic relief of cough....

Benzonatate- Benzonatate Capsule

Benzonatate capsules are indicated for the symptomatic relief of cough....

Benzonatate- Benzonatate Capsule

Benzonatate capsules are indicated for the symptomatic relief of cough....

Benzphetamine Hydrochloride Tablet

hydrochloride tablets are indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an ini...

Benzphetamine Hydrochloride Tablet, Film Coated

Benzphetamine Hydrochloride Tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients...

Benzphetamine Hydrochloride- Benzphetamine Hydrochloride Tablets Tablet, Film Coated

Benzphetamine hydrochloride tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients...

Berinert- Human C1-esterase Inhibitor Kit

BERINERT is a plasma-derived concentrate of C1 Esterase Inhibitor (Human) indicated for the treatment of acute abdominal, facial, or laryngeal hereditary angioedema (HAE) attacks in adult and pediatri...

Besivance- Besifloxacin Suspension

BESIVANCE (besifloxacin ophthalmic suspension) 0.6%, is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria: Aerococcus viridans* CDC co...

Besponsa- Inotuzumab Ozogamicin Injection, Powder, Lyophilized, For Solution

BESPONSA is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)....

Betapace- Sotalol Hydrochloride Tabletbetapace Af- Sotalol Hydrochloride Tablet

1.1 Life-Threatening Ventricular Arrhythmias Betapace/Betapace AF is indicated for the treatment of life-threatening, documented ventricular arrhythmias, such as sustained ventricular tachycardia (VT...

Betaseron- Interferon Beta-1b Kit

BETASERON is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, ...

Bethanechol Chloride Tablet

Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention....

Bethanechol Chloride- Bethanechol Chloride 5 Mg Tabletbethanechol Chloride- Bethanechol Chloride 10 Mg Tabletbethanechol Chloride- Bethanechol Chloride 25 Mg Tabletbethanechol Chloride- Bethanechol Chloride 50 Mg Tablet

Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention....

Betoptic Pilo- Betaxolol Hydrochloride And Pilocarpine Hydrochloride

Betoptic Pilo Ophthalmic Suspension is indicated for the reduction of elevated intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension who are insufficiently respons...

Bevyxxa- Betrixaban Capsule, Gelatin Coated

BEVYXXA is indicated for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or...

Biaxin- Clarithromycin Tablet, Film Coatedbiaxin- Clarithromycin Tablet, Film Coated, Extended Releasebiaxin- Clarithromycin Granule, For Suspension

BIAXIN Filmtab (clarithromycin tablets, USP) and BIAXIN Granules (clarithromycin for oral suspension, USP) are indicated for the treatment of mild to moderate infections caused by susceptible strains ...

Bicalutamide Tablet

Bicalutamide tablets 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the pros...

Bicalutamide Tablet, Film Coated

Bicalutamide tablets 50 mg daily are indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prost...

Bicnu- Carmustine Kit

BiCNU (carmustine for injection) is indicated as palliative therapy as a single agent or in established combination therapy in the following: Brain tumors glioblastoma, brainstem glioma, medulloblas...

Bidil- Hydralazine Hydrochloride And Isosorbide Dinitrate Tablet, Film Coated

1.1 Treatment of Heart Failure in Self-identified Black Patients BiDil is indicated for the treatment of heart failure as an adjunct to standard therapy in self-identified black patients to improve s...

Bijuva- Estradiol And Progesterone Capsule

1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause....

Biltricide- Praziquantel Tablet, Film Coated

Biltricide is indicated in patients aged 1 year and older for the treatment of the following infections: Schistosomiasis due to all species of schistosoma (for example, Schistosoma mekongi, Schis...

Bimatoprost Solution

Bimatoprost ophthalmic solution 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness....

Bimatoprost Solution/ Drops

Bimatoprost ophthalmic solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension....

Bioferr 90- Dual-iron Tablet, Film Coated

BioFerr 90 is indicated for the treatment of all anemias that are responsive to oral iron therapy. These include: hypochromic anemia associated with pregnancy, chronic and/or acute blood loss, meta...

Bismuth Subsalicylate/metronidazole/tetracycline Hydrochloride- Bismuth Subsalicylate Chewable Tablets/metronidazole Tablets/tetracycline Hydrochloride Capsules Kit

The components of Bismuth Subsalicylate Chewable Tablets/ Metronidazole Tablets/Tetracycline Hydrochloride Capsules (bismuth subsalicylate, metronidazole, and tetracycline hydrochloride), in combinati...

Bivalirudin In 0.9% Sodium Chloride- Bivalirudin In 0.9% Sodium Chloride Injection Injection

Bivalirudin Injection is an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI)....

Bivalirudin Injection

Bivalirudin for Injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and ...

Bivigam (immune Globulin Intravenous- Human 10% Liquid

1.1 Primary Humoral Immunodeficiency BIVIGAM is an Immune Globulin Intravenous (Human), 10% Liquid, indicated for the treatment of patients with primary humoral immunodeficiency (PI).This includes, bu...

Bivigam- Human Immunoglobulin G Injection, Solution

1.1 Primary Humoral Immunodeficiency BIVIGAM is an Immune Globulin Intravenous (Human), 10% Liquid, indicated for the treatment of patients with primary humoral immunodeficiency (PI).This includes, bu...

Bivigam- Human Immunoglobulin G Injection, Solutionbivigam- Human Immunoglobulin G Injection, Solution

1.1 Primary Humoral Immunodeficiency BIVIGAM is an Immune Globulin Intravenous (Human), 10% Liquid, indicated for the treatment of patients with primary humoral immunodeficiency (PI). Th...

Bleomycin Injection

Bleomycin for injection should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with...

Bleomycin Injection, Powder, Lyophilized, For Solution

Bleomycin for Injection, USP should be considered a palliative treatment. It has been shown to be useful in the management of the Squamous Cell Carcinoma Head and neck (including mouth, tongue, ton...

Bleomycin Powder, For Solution

Bleomycin for Injection, USP should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations...

Bleomycin- Bleomycin Sulfate Injection, Powder, Lyophilized, For Solution

Bleomycin for Injection, USP should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinati...

Bleomycin- Bleomycin Sulfate Powder, For Solution

Bleomycin for Injection, USP should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations...

Bleph-10- Sulfacetamide Sodium Solution/ Drops

BLEPH -10 solution is indicated for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of ...

Blephamide- Sulfacetamide Sodium And Prednisolone Acetate Ointment

BLEPHAMIDE ophthalmic ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk o...

Blephamide- Sulfacetamide Sodium And Prednisolone Acetate Suspension/ Drops

A steroid/anti-infective combination is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a ri...

Blincyto- Blinatumomab Kit

1.1 MRD-positive B-cell Precursor ALL BLINCYTO is indicated for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal re...

Bloxiverz- Neostigmine Methylsulfate Injection

BLOXIVERZ is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery....

Bonjesta- Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Extended Release

BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use BONJESTA has not been studied in women with hyp...

Boostrix- Tetanus Toxoid, Reduced Diphtheria Toxoid And Acellular Pertussis Vaccine, Adsorbed Suspension

BOOSTRIX is indicated for active booster immunization against tetanus, diphtheria, and pertussis. BOOSTRIX is approved for use as a single dose in individuals aged 10 years and older....

Bortezomib Injection, Powder, Lyophilized, For Solution

1.1 Multiple Myeloma Bortezomib for Injection is indicated for the treatment of patients with multiple myeloma. 1.2 Mantle Cell Lymphoma Bortezomib for Injection is indicated for the treatment o...

Bosentan Tablet

Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): in adults to improve exercise ability and to decrease clinical worsening. Studies establishi...

Bosentan Tablet, Coated

Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): in adults to improve exercise ability and to decrease clinical worsening. Studies establishi...

Bosentan Tablet, Film Coated

Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): in adults to improve exercise ability and to decrease clinical worsening. Studies establishing ...

Bosulif- Bosutinib Monohydrate Tablet, Film Coated

BOSULIF is indicated for the treatment of adult patients with: Newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). This indication is approved ...

Botox Cosmetic- Onabotulinumtoxina Injection, Powder, Lyophilized, For Solution

BOTOX Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of: moderate to severe glabellar lines associated with corrugator and/or procerus...

Botox- Onabotulinumtoxina Injection, Powder, Lyophilized, For Solution

1.1 Bladder Dysfunction Overactive Bladder BOTOX (onabotulinumtoxinA) for injection is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urg...

Brevital Sodium- Methohexital Sodium Injection, Powder, Lyophilized, For Solution

BREVITAL can be used in adults as follows: 1.For intravenous induction of anesthesia prior to the use of other general anesthetic agents. 2.For intravenous induction of anesthesia and as an adjunct t...

Brilinta- Ticagrelor Tablet

BRILINTA is indicated to reduce the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction (MI). For at le...

Brineura- Cerliponase Alfa Kit

Brineura is indicated to slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripept...

Brisdelle- Paroxetine Capsule

BRISDELLE is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Limitation of Use: ...

Briviact- Brivaracetam Tablet, Film Coatedbriviact- Brivaracetam Solutionbriviact- Brivaracetam Injection, Suspension

BRIVIACT is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. As the safety of BRIVIACT injection in pediatric patients has not been established, BRIVIACT inj...

Bromocriptine Mesylate Capsule

Hyperprolactinemia-Associated Dysfunctions: Bromocriptine mesylate tablets and capsules are indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or ...

Bromocriptine Mesylate Tablet

Hyperprolactinemia-Associated Dysfunctions Bromocriptine mesylate tablets, USP are indicated for the treatment of dysfunctions associated with hyperprolactinemia includin...

Bromocriptine Mesylate Tabletbromocriptine Mesylate Capsule

Hyperprolactinemia-Associated Dysfunctions Bromocriptine mesylate tablets and capsules are indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or w...

Bromocriptine Mesylate- Bromocriptine Mesylate Tablet

Hyperprolactinemia-Associated Dysfunctions Bromocriptine mesylate tablets are indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galact...

Bronchial Asthma Relief- Ephedrine Hcl, Guaifenesin Tablet

for temporarily relief of mild symptoms of intermittent asthma: wheezing tightness of chest shortness of breath helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways o...

Bss- Balanced Salt Solution Solution

For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes....

Budeprion Sr- Bupropion Hydrochloride Tablet, Extended Release

Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder. The efficacy of bupropion in the treatment of a major depressive episode was establi...

Budeprion Xl Xl- Bupropion Hydrochloride Tablet, Film Coated, Extended Release

INDICATIONS AND USAGEMajor Depressive Disorder: Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder. The efficacy of bupropion in the tre...

Budeprion- Bupropion Hydrochloride Tablet, Extended Release

Major Depressive Disorder: Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder. The efficacy of bupropion in the treatment of a major dep...

Bumetanide Injection

Bumetanide Injection is indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occur...

Bumetanide Injection, Solution

Bumetanide injection is indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occu...

Bumetanide Tablet

Bumetanide tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs...

Bunavail- Buprenorphine And Naloxone Film

BUNAVAIL is indicated for the treatment of opioid dependence. BUNAVAIL should be used as part of a complete treatment plan that includes counseling and psychosocial support....

Bupap- Butalbital And Acetaminophen Tablets Tablet

BUPAP Tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment ...

Buphenyl- Sodium Phenylbutyrate Tabletbuphenyl- Sodium Phenylbutyrate Powder

BUPHENYL is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OT...

Buprenex- Buprenorphine Hydrochloride Injection

BUPRENEX is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitations of Use Because of the risks of addictio...

Buprenorphine And Naloxone Film

Buprenorphine and naloxone sublingual film is indicated for treatment of opioid dependence. Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes...

Buprenorphine And Naloxone Film, Soluble

Buprenorphine and naloxone sublingual film is indicated for treatment of opioid dependence. Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes...

Buprenorphine And Naloxone Sublingual Film- Buprenorphine And Naloxone Film

Buprenorphine and naloxone sublingual film is indicated for treatment of opioid dependence. Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes...

Buprenorphine And Naloxone Tablet

Buprenorphine and naloxone sublingual tablet is indicated for the maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual tablet should be used as part of a complete treatmen...

Buprenorphine And Naloxone- Buprenorphine Hydrochloride And Naloxone Hydrochloride Tablet

Buprenorphine and naloxone sublingual tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual tablets should be used as part of a complete treat...

Buprenorphine And Naloxone- Buprenorphine Hydrochloride, Naloxone Hydrochloride Film, Soluble

Buprenorphine and naloxone sublingual film is indicated for treatment of opioid dependence. Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that include...

Buprenorphine Hcl And Naloxone Hcl- Buprenorphine And Naloxone Tablet

Buprenorphine and Naloxone Sublingual Tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and Naloxone Sublingual Tablets should be used as part of a complete treat...

Bupropion Hydrochloride (bupropion Hydrochloride Extended-release Tablets- Xl Tablet, Extended Release

1.1 Major Depressive Disorder Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Ma...

Bupropion Hydrochloride- Bupropion Hydrochloride Tablet, Film Coated, Extended Release

Bupropion hydrochloride extended-release tablets (SR) are indicated as an aid to smoking cessation treatment....

Bupropion- Bupropion Hydrochloride Tablet, Extended Release

Bupropion Hydrochloride Extended-release (SR) tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bup...

Bupropion- Bupropion Hydrochloride Tablet, Extended Releasebupropion- Bupropion Hydrochloride Tablet, Extended Release

Bupropion Hydrochloride Extended-release (SR) tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bup...

Busulfan Injection

Busulfan Injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemi...

Busulfan Injection, Solution

Busulfan Injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemi...

Busulfan- Busulfan Injection, Solution

Busulfan injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemi...

Butalbital Acetaminophen And Caffeine Tablet

Butalbital, acetaminophen and caffeine tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this comb...

Butalbital And Acetaminophen Capsule

Butalbital and acetaminophen capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination p...

Butalbital And Acetaminophen Tablet

Butalbital and acetaminophen tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination pr...

Butalbital And Acetaminophen Tabletbutalbital And Acetaminophen Tablet

Butalbital and Acetaminophen tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination pr...

Butalbital And Acetaminophen- Butalbital And Acetaminophen Tablets Tablet

Butalbital and Acetaminophen Tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination pr...

Butorphanol Tartrate Injection, Solution

Butorphanol Tartrate Injection is indicated: as a preoperative or pre-anesthetic medication as a supplement to balanced anesthesia for the relief of pain during labor, and for the management of pain ...

Butorphanol Tartrate Spray

Butorphanol tartrate nasal spray is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because...

Butorphanol Tartrate Spray, Metered

Butorphanol Tartrate Nasal Spray is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because ...

Butorphanol Tartrate- Butorphanol Tartrate Spray

Butorphanol Tartrate Nasal Spray is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of UseBecause of ...

Bydureon Bcise- Exenatide Injection, Suspension, Extended Release

BYDUREON BCISE is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14)]. Limitations of Use BYDUREON BCISE i...

Bydureon- Exenatide Injection, Suspension, Extended Releasebydureon- Exenatide Kit

BYDUREON is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14)]. Limitations of Use: BYDUREON is not recom...

Byetta- Exenatide Injection

1.1 Type 2 Diabetes Mellitus BYETTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 1.2 Important Limitations of Use BYETTA is n...

C

Cabergoline Tablet

Cabergoline Tablets are indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas....

Cabometyx- Cabozantinib Tablet

1.1 Renal Cell Carcinoma CABOMETYX is indicated for the treatment of patients with advanced renal cell carcinoma (RCC). 1.2 Hepatocellular Carcinoma CABOMETYX is indicated for the treatment of pati...

Cafergot- Ergotamine Tartrate And Caffeine Tablet, Film Coated

CAFERGOT (ergotamine tartrate and caffeine tablets, USP) are indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants, or so-called "histaminic cephalalgia"....

Calan Sr- Verapamil Hydrochloride Tablet, Film Coated, Extended Release

CALAN SR is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial...

Calan- Verapamil Hydrochloride Tablet, Film Coated

CALAN tablets are indicated for the treatment of the following: Angina Angina at rest including: Vasospastic (Prinzmetal's variant) angina Unstable (crescendo, pre-i...

Calcitonin Salmon Spray, Metered

1.1 Treatment of Postmenopausal Osteoporosis Calcitonin-salmon nasal spray is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. Fracture ...

Calcitriol Capsule

Predialysis Patients Calcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 t...

Calcitriol Capsule, Liquid Filled

Predialysis Patients Calcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 t...

Calcitriol Capsulecalcitriol Solution

Predialysis Patients Calcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 t...

Calcitriol- Calcitriol 0.25 Mcg Capsule

Predialysis Patients Calcitriol capsule is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (...

Calcitriol- Calcitriol Capsules 0.25 Mcg Capsule

Predialysis Patients Calcitriol capsule is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (...

Calcitriol- Calcitriol Capsules 0.25 Mcg Capsulecalcitriol- Calcitriol Capsules 0.5 Mcg Capsule

Predialysis Patients Calcitriol capsule is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (...

Calcium Acetate Capsule

Calcium Acetate Capsules are indicated for the control of hyperphosphatemia in end stage renal failure and do not promote aluminum absorption....

Calcium Disodium Versenate- Edetate Calcium Disodium Injection

Edetate calcium disodium is indicated for the reduction of blood levels and depot stores of lead in lead poisoning (acute and chronic) and lead encephalopathy, in both pediatric populations and adults...

Calcium Gluconate Injection, Solution

Calcium gluconate is used to treat conditions arising from calcium deficiencies such as hypocalcemic tetany, hypocalcemia related to hypoparathyroidism and hypocalcemia due to rapid growth or pregnanc...

Calquence- Acalabrutinib Capsule, Gelatin Coated

CALQUENCE is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated approval based on...

Campath- Alemtuzumab Injection

CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL)....

Camptosar- Irinotecan Hydrochloride Injection, Solution

CAMPTOSAR Injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum. CAMPT...

Camrese- Levonorgestrel / Ethinyl Estradiol And Ethinyl Estradiol Kit

CAMRESE (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy....

Canasa- Mesalamine Suppository

CANASA is indicated in adults for the treatment of mildly to moderately active ulcerative proctitis....

Cancidas- Caspofungin Acetate Injection, Powder, Lyophilized, For Solution

1.1 Empirical Therapy for Presumed Fungal Infections in Febrile, Neutropenic Patients CANCIDAS is indicated as empirical therapy for presumed fungal infections in febrile, neutropenic adult and pedi...

Candin- Candida Albicans Skin Test Antigen Injection, Solution

CANDIN is indicated for use as a recall antigen for detecting cell-mediated hypersensitivity by intracutaneous (intradermal) testing. The product may be useful in evaluating the cellular immune respo...

Capastat Sulfate- Capreomycin Injection, Powder, For Solution

Capastat Sulfate, which is to be used concomitantly with other appropriate antituberculosis agents, is indicated in pulmonary infections caused by capreomycin-susceptible strains of M. tuberculosis w...

Caprelsa- Vandetanib Tablet

CAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. Use CAPRELSA in patients with indol...

Caprelsa- Vandetanib Tablet, Film Coated

CAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. Use CAPRELSA in patients with indol...

Capreomycin Sulfate- Capreomycin Injection, Powder, For Solution

Capreomycin for injection, which is to be used concomitantly with other appropriate antituberculosis agents, is indicated in pulmonary infections caused by capreomycin-susceptible strains of ...

Carafate- Sucralfate Suspension

CARAFATE (sucralfate) Oral Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer....

Carafate- Sucralfate Tablet

CARAFATE (sucralfate) is indicated in: Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be cont...

Carbaglu- Carglumic Acid Tablet

1.1 Acute Hyperammonemia in Patients with NAGS Deficiency CARBAGLU is indicated as an adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia due to the deficiency...

Carbamazepine Capsule, Extended Release

Epilepsy Carbamazepine extended-release capsules are indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-contr...

Carbamazepine Er- Carbamazepine Tablet, Extended Release

Epilepsy Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled ...

Carbamazepine Suspension

Epilepsy Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled ...

Carbamazepine Tablet

Carisoprodol tablets, USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol tablets, USP should only be used for short perio...

Carbamazepine Tablet, Chewable

Epilepsy Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled ...

Carbamazepine Tablet, Extended Release

Epilepsy Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled ...

Carbamazepine Tabletcarbamazepine Tablet, Chewable

Epilepsy Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled ...

Carbamazepine- Carbamazepine Tabletcarbamazepine- Carbamazepine Tablet, Chewable

Epilepsy Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled...

Carbastat- Carbachol Injection, Solution

Intraocular use for obtaining miosis during surgery. In addition, Carbastat (Carbachol Intraocular Solution USP) reduces the intensity of intraocular pressure elevation in the first 24 hours after c...

Carbatrol- Carbamazepine Capsule, Extended Release

EpilepsyCarbatrol is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled pat...

Carbidopa And Levodopa Tablet

Carbidopa and levodopa tablets, USP are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or ...

Carbidopa And Levodopa Tablet, Extended Release

Carbidopa and levodopa extended-release tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide into...

Carbidopa And Levodopa- Carbidopa And Levodopa Tablet, Extended Release

Carbidopa and levodopa extended-release tablets are indicated in the treatment of the symptoms of idiopathic Parkinson s disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic p...

Carbidopa, Levodopa And Entacapone Tablet, Film Coated

Carbidopa, levodopa and entacapone tablets, a combination drug consisting of levodopa, carbidopa (dopa decarboxylase inhibitor), and entacapone (catechol-O-methyltransferase-COMT inhibitor) is indicat...

Carbidopa, Levodopa, And Entacapone Tablet, Film Coated

Carbidopa, levodopa and entacapone tablets, a combination drug consisting of levodopa, carbidopa (dopa decarboxylase inhibitor), and entacapone (catechol-O-methyltransferase-COMT inhibitor) is indicat...

Carboprost Tromethamine- Carboprost Tromethamine Injection, Solution

Carboprost tromethamine, USP is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following ...

Carimune Nanofiltered- Human Immunoglobulin G Injection, Powder, Lyophilized, For Solution

Immunodeficiency Carimune NF is indicated for the maintenance treatment of patients with primary immunodeficiencies (PID), e.g., common variable immunodeficiency, X-linked agammaglobulinemia, severe...

Carisoprodol And Aspirin Tablet

Carisoprodol and Aspirin Tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol and Aspirin Tablets should only be used fo...

Carisoprodol Immediate Release- Carisoprodol Tablet

Carisoprodol tablets USP is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Limitation of Use Carisoprodol tablets USP should only be used f...

Carisoprodol Tablet

Carisoprodol Tablets USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol Tablets USP should only be used for short periods...

Carisoprodol- Carisoprodol Tablet

Carisoprodol Tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Limitation of Use Carisoprodol Tablets should only be used for shor...

Carisoprodol- Carisoprodol Tablets Tablet

Carisoprodol Tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.Carisoprodol Tablets should only be used for short periods (up to tw...

Carnitor Sf- Levocarnitine Solution

CARNITOR (levocarnitine) is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encepha...

Carnitor- Levocarnitine Injection, Solution

For the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency. For the prevention and treatment of carnitine deficiency in patient...

Carnitor- Levocarnitine Solution

CARNITOR (levocarnitine) is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encepha...

Carnitor- Levocarnitine Tablet

CARNITOR (levocarnitine) is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encepha...

Carospir Suspension

CAROSPIR (spironolactone) is indicated in the management of: 1.1 Heart Failure CAROSPIR is indicated for treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase surviv...

Carticel- Autologous Cultured Chondrocytes Implant

Carticel is indicated for the repair of symptomatic cartilage defects of the femoral condyle (medial, lateral or trochlea), caused by acute or repetitive trauma, in patients who have had an inadequa...

Carvedilol Phosphate Capsule, Extended Release

1.1 Heart Failure Carvedilol Phosphate extended-release capsules are indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to d...

Carvedilol Tablet

1.1 Heart Failure Carvedilol Tablets is indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE ...

Carvedilol Tablet, Film Coated

1.1 Heart Failure Carvedilol tablets are indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, an...

Carvedilol- Carvedilol Tablet, Coated For Oral Use

1.1 Left Ventricular Dysfunction following Myocardial Infarction Carvedilol is indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocard...

Carvedilol- Carvedilol Tablet, Film Coated

1.1 Left Ventricular Dysfunction Following Myocardial Infarction: Carvedilol tablets are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of...

Casodex- Bicalutamide Tablet

CASODEX 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate. CASODEX...

Caspofungin Acetate Injection

1.1 Empirical Therapy for Presumed Fungal Infections in Febrile, Neutropenic Patients Caspofungin acetate for injection is indicated as empirical therapy for presumed fungal infections in febrile, neu...

Caspofungin Acetate Injection, Powder, For Solution

1.1 Empirical Therapy for Presumed Fungal Infections in Febrile, Neutropenic Patients Caspofungin acetate for injection is indicated as empirical therapy for presumed fungal infections in febrile, n...

Caspofungin Acetate Injection, Powder, Lyophilized, For Solution

1.1 Empirical Therapy for Presumed Fungal Infections in Febrile, Neutropenic Patients Caspofungin acetate for injection is indicated as empirical therapy for presumed fungal infections in febrile, neu...

Cat Hair, Standardized Injection, Solutioncat Hair, Standardized Solution

Standardized Cat Hair allergenic extracts are indicated for the diagnostic skin testing and immunotherapy of patients whose histories indicate that they experience allergic symptoms upon natural expos...

Cat Pelt, Standardized Injection, Solutioncat Pelt, Standardized Solution

This product is indicated for the diagnosis and treatment (hyposensitization therapy) of patients who experience allergic symptoms due to exposure to cats and who exhibit type I skin sensitivity when ...

Catapres- Clonidine Hydrochloride Tablet

CATAPRES tablets are indicated in the treatment of hypertension. CATAPRES tablets may be employed alone or concomitantly with other antihypertensive agents....

Catapres- Clonidine Patch, Extended Release

Catapres-TTS (clonidine) transdermal therapeutic system is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents....

Catapres-tts- Clonidine Patch

Catapres TTS transdermal therapeutic system is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents....

Caverject Impulse- Alprostadil Injection, Powder, Lyophilized, For Solution

1.1 Erectile Dysfunction CAVERJECT IMPULSE is indicated for the treatment of erectile dysfunction. 1.2 Diagnostic Test CAVERJECT IMPULSE is indicated as an adjunct to other diagnostic tests in the ...

Caverject- Alprostadil Injection, Powder, Lyophilized, For Solution

1.1 Erectile Dysfunction CAVERJECT is indicated for the treatment of erectile dysfunction. 1.2 Diagnostic Testing for Erectile Dysfunction CAVERJECT is indicated as an adjunct to other diagnostic...

Cayston- Aztreonam Kit

CAYSTON is indicated to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa. Safety and effectiveness have not been established in pediatric patients below the ...

Cedax- Ceftibuten Dihydrate Capsulecedax- Ceftibuten Dihydrate Suspension

CEDAX (ceftibuten) is indicated for the treatment of individuals with mild-to-moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below...

Cefaclor Capsule

Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Otitis media caused by Streptococcus pneumoniae, Haemophilus in...

Cefaclor For Suspension

Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Otitis media caused by Streptococcus pneumoniae, Haemophilus i...

Cefaclor Suspension

Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Otitis media caused by Streptococcus pneumoniae, Haemophilus inf...

Cefaclor Tablet, Film Coated, Extended Release

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefaclor extended-release tablets USP and other antibacterial drugs, cefaclor extended-release tablets USP should...

Cefadroxil Capsule

Cefadroxil Capsules, USP are indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases: Urinary tract infections cause...

Cefadroxil- Cefadroxil Hemihydrate Capsule

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefadroxil Tablets and Cefadroxil Capsules and other antibacterial drugs, Cefadroxil Tablets and Cefadroxil cap...

Cefadroxil- Cefadroxil Monohydrate Powder, For Suspension

Cefadroxil monohydrate, USP is indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases: Urinary tract infections caus...

Cefadroxil- Cefadroxil Tablet, Film Coated

Cefadroxil monohydrate is indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases: Urinary tract infections caused by...

Celexa- Citalopram Hydrobromide Tablet

Celexa (citalopram HBr) is indicated for the treatment of depression. The efficacy of Celexa in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagno...

Celexa- Citalopram Tablet, Film Coated

Celexa (citalopram) is indicated for the treatment of depression. The efficacy of Celexa in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis ...

Cellcept- Mycophenolate Mofetil Capsule

Renal, Cardiac, and Hepatic Transplant CellCept is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. CellCept should be used conc...

Cellcept- Mycophenolate Mofetil Tablet, Film Coatedcellcept- Mycophenolate Mofetil Capsulecellcept- Mycophenolate Mofetil Hydrochloride Injection, Powder, Lyophilized, For Solutioncellcept- Mycophenolate Mofetil Powder, For Suspension

CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in recipients of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liv...

Centany At- Mupirocin Ointment

CENTANY ointment is indicated for the topical treatment of impetigo due to: Staphylococcus aureus and Streptococcus pyogenes....

Centany- Mupirocin Ointment

Centany (mupirocin ointment),2% is indicated for the topical treatment of impetigo due to: Staphylococcus aureus and Streptococcus pyogenes....

Centany- Mupirocin Ointment

CENTANY ointment is indicated for the topical treatment of impetigo due to: Staphylococcus aureus and Streptococcus pyogenes....

Center-al - Populus Deltoides Ssp. Monilifera Pollen- Allergenic Extracts Alum Precipitated Injection, Suspensioncenter-al - Rumex Acetosella Pollen- Allergenic Extracts Alum Precipitated Injection, Suspensioncenter-al - Rumex Crispus Pollen- Allergenic Extracts Alum Precipitated Injection, Suspensioncenter-al - Ulmus Americana Pollen- Allergenic Extracts Alum Precipitated Injection, Suspensioncenter-al - Ulmus Pumila Pollen- Allergenic Extracts Alum Precipitated Injection, Suspensioncenter-al - Corylus Americana Pollen- Allergenic Extracts Alum Precipitated Injection, Suspensioncenter-al - Carya Ovata Pollen- Allergenic Extracts Alum Precipitated Injection, Suspensioncenter-al - House Dust- Allergenic Extracts Alum Precipitated Injection, Suspensioncenter-al - Sorghum Halepense Pollen- Allergenic Extracts Alum Precipitated Injection, Suspensioncenter-al - Poa Pratensis Pollen- Allergenic Extracts Alum Precipitated Injection, Suspensioncenter-al - Kochia Scoparia Pollen- Allergenic Extracts Alum Precipitated Injection, Suspension

Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants, in situations where...

Cequa- Cyclosporine Solution/ Drops

CEQUA ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). (1)...

Cerdelga- Eliglustat Capsule

CERDELGA is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1) who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers...

Cerebyx- Fosphenytoin Sodium Injection, Solution

CEREBYX is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. CEREBYX can also be substituted, short-ter...

Cerezyme- Imiglucerase Injection, Powder, Lyophilized, For Solution

Cerezyme (imiglucerase for injection) is indicated for long-term enzyme replacement therapy for pediatric and adult patients with a confirmed diagnosis of Type 1 Gaucher disease that results in one ...

Certus Pvp-1 Prep Swabstick- Povidone-iodine Swab

health-care antiseptic for preparation of the skin prior to surgery...

Cervidil- Dinoprostone Insert

Cervidil Vaginal Insert (dinoprostone, 10 mg) is indicated for the initiation and/or continuation of cervical ripening in patients at or near term in whom there is a medical or obstetrical indication ...

Cesamet- Nabilone Capsule

Cesamet capsules are indicated for the treatment of the nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments....

Cetraxal- Ciprofloxacin Solution/ Drops

CETRAXAL is a quinolone antimicrobial indicated for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus....

Cetrotide- Cetrorelix Acetate Kit

Cetrotide (cetrorelix acetate for injection) is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation....

Cevimeline Capsule

Cevimeline hydrochloride capsules are indicated for the treatment of symptoms of dry mouth in patients with Sj gren s Syndrome....

Cevimeline Hydrochloride Capsule

Cevimeline is indicated for the treatment of symptoms of dry mouth in patients with Sj gren s Syndrome....

Chantix- Varenicline Tartrate Kit

CHANTIX is indicated for use as an aid to smoking cessation treatment....

Chantix- Varenicline Tartrate Kitchantix- Varenicline Tartrate Tablet, Film Coated

CHANTIX is indicated for use as an aid to smoking cessation treatment....

Chantix- Varenicline Tartrate Tablet, Film Coated

CHANTIX is indicated for use as an aid to smoking cessation treatment....

Chantix- Varenicline Tartrate Tablet, Film Coatedchantix- Varenicline Tartrate Kit

CHANTIX is indicated for use as an aid to smoking cessation treatment....

Chemet- Succimer Capsule

CHEMET is indicated for the treatment of lead poisoning in pediatric patients with blood lead levels above 45 mcg/dL. CHEMET is not indicated for prophylaxis of lead poisoning in a lead-containing env...

Chloramphenicol Sodium Succinate Injection, Powder, Lyophilized, For Solution

In accord with the concepts in the Warning Box and this INDICATIONS AND USAGE section, chloramphenicol must be used only in those serious infections for which less potentially dangerous drugs are ...

Chlordiazepoxide Hydrochloride And Clidinium Bromide Capsule

Based on a review of this drug by the National Academy of Sciences National Research Council and/or other information, FDA has classified the indications as follows: "Possibly" effective: as adjun...

Chlordiazepoxide Hydrochloride/clidinium Bromide- Chlordiazepoxide Hydrochloride And Clidinium Bromide Capsule

Chlordiazepoxide Hydrochloride/Clidinium Bromide is indicated to control the emotional and somatic factors in gastrointestinal disorders. Chlordiazepoxide Hydrochloride/Clidinium Bromide may also be u...

Chloromycetin- Chloramphenicol Ointment

Chloramphenicol should be used only in those serious infections for which less potentially dangerous drugs are ineffective or contraindicated. Bacteriological studies should be performed to determine ...

Chloroprocaine Hci Injection, Solution

Nesacaine 1% and 2% Injections, in multidose vials with methylparaben as preservative, are indicated for the production of local anesthesia by infiltration and peripheral nerve block. They are not to...

Chloroprocaine Hydrochloride Injection, Solution

Chloroprocaine hydrochloride injection 2% and 3%, in single dose vials, without methylparaben preservative, without EDTA, is indicated for the production of local anesthesia by infiltration, periphera...

Chlorpromazine Hci Injection

For the treatment of schizophrenia; to control nausea and vomiting; for relief of restlessness and apprehension before surgery; for acute intermittent porphyria; as an adjunct in the treatment of teta...

Chlorpromazine Hydrochloride Injection

For the treatment of schizophrenia; to control nausea and vomiting; for relief of restlessness and apprehension before surgery; for acute intermittent porphyria; as an adjunct in the treatment of teta...

Chlorpromazine Hydrochloride Tablet, Film Coated

For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute i...

Chlorpromazine Hydrochloride Tablet, Sugar Coated

For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute i...

Chlorpromazine- Chlorpromazine Hydrochloride Tablet, Film Coated

For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute i...

Chlorthalidone Tablet

Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms ...

Chlorthalidone- Chlorthalidone Tablet

Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms ...

Cholbam- Cholic Acid Capsule

1.1 Bile Acid Synthesis Disorders due to Single Enzyme Defects CHOLBAM is indicated for the treatment of bile acid synthesis disorders due to single enzyme defects (SEDs) [see ...

Cholestyramine Light Powder, For Suspension

1) Cholestyramine for Oral Suspension Light powder is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated lo...

Cholestyramine Powder, For Suspension

1) Cholestyramine for oral suspension is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lip...

Chorionic Gonadotropin Kit

HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRI...

Cialis- Tadalafil Tablet, Film Coated

1.1 Erectile Dysfunction CIALIS is indicated for the treatment of erectile dysfunction (ED). 1.2 Benign Prostatic Hyperplasia CIALIS is indicated for the treatment of the signs and sy...

Ciclodan- Ciclopirox Solution

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) Ciclodan Ciclopirox Topical Solution, 8%, (Nail Lacquer), as a component...

Ciclopirox Gel

Superficial Dermatophyte Infections Ciclopirox Gel is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epi...

Ciclopirox Kit

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) Ciclopirox Topical Solution, 8% (Nail Lacquer), as a component of a compreh...

Ciclopirox Lotion

Ciclopirox Topical Suspension USP, 0.77% (Lotion) is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, ...

Ciclopirox Olamine Cream

Ciclopirox olamine cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, ...

Ciclopirox Olamine- Ciclopirox Olamine Cream

Ciclopirox Olamine Cream USP, 0.77% is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton me...

Ciclopirox- Ciclopirox Solution

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.)Ciclopirox Topical Solution, 8%, (Nail Lacquer), as a component of a compreh...

Cilostazol Tablet

Cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance....

Ciloxan- Ciprofloxacin Hydrochloride Ointment

CILOXAN (ciprofloxacin ophthalmic ointment) 0.3% is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the microorganisms listed below: Gram-Positive:Staphyloco...

Ciloxan- Ciprofloxacin Hydrochloride Solution

CILOXAN Ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below: Corneal Ulcers:Pseudomonas ae...

Ciloxan- Ciprofloxacin Hydrochloride Solution/ Drops

CILOXAN Ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below: Corneal Ulcers: Pseudomonas aer...

Cimzia- Certolizumab Pegol Kitcimzia- Certolizumab Pegol Injection, Solution

1.1 Crohn's Disease CIMZIA is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had a...

Cinacalcet Hydrochloride Tablet, Film Coated

1.1 Secondary Hyperparathyroidism Cinacalcet hydrochloride tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dial...

Cinacalcet Tablet

1.1 Secondary Hyperparathyroidism Cinacalcet hydrochloride tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysi...

Cinacalcet Tablet, Film Coated

1.1 Secondary Hyperparathyroidism Cinacalcet are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis [see Clinical Stu...

Cinqair- Reslizumab Injection, Solution, Concentrate

CINQAIR is indicated for the add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype [see Clinical Studies (14)]. Limitation of Use: CINQA...

Cinryze- Human C1-esterase Inhibitor Injection, Powder, Lyophilized, For Solution

CINRYZE is a C1 esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adults, adolescents and pediatric patients (6 years old and above) with Hereditary Angioedema (HAE)....

Cinvanti- Aprepitant Injection, Emulsion

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetoge...

Cipro Hc- Ciprofloxacin Hydrochloride And Hydrocortisone Suspension

CIPRO HC OTIC is indicated for the treatment of acute otitis externa in adult and pediatric patients, one year and older, due to susceptible strains of Pseudomonas aeruginosa, Staphylococcus aureus,...

Cipro- Ciprofloxacin Hydrochloride Tablet, Film Coatedcipro- Ciprofloxacin Kit

1.1 Skin and Skin Structure Infections CIPRO is indicated in adult patients for treatment of skin and skin structure infectionscaused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae...

Cipro- Ciprofloxacin Hydrochloride, Hydrocortisone And Benzyl Alcohol Suspension

CIPRO HC OTIC is indicated for the treatment of acute otitis externa in adult and pediatric patients, one year and older, due to susceptible strains of Pseudomonas aeruginosa, Staphylococcus aure...

Ciprodex- Ciprofloxacin And Dexamethasone Suspension

CIPRODEX Otic is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Acute Otitis Media in pediatric ...

Cisatracurium Besylate Injection

Cisatracurium Besylate Injection is indicated: as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age to provide skeletal...

Cisatracurium- Cisatracurium Besylate Injection, Solution

Cisatracurium Besylate Injection is an intermediate-onset/intermediate-duration neuromuscular blocking agent indicated for inpatients and outpatients as an adjunct to general anesthesia, to facilitate...

Cisplatin Injection

1.1 Advanced Testicular Cancer Cisplatin injection is indicated for the treatment of advanced testicular cancer. 1.2 Advanced Ovarian Cancer Cisplatin injection is indicated for the treatment of ...

Cisplatin Injection, Powder, Lyophilized, For Solution

Cisplatin for injection, USP is indicated as therapy to be employed as follows: 1.1 Advanced Testicular Cancer Cisplatin for injection is indicated for the treatment of advanced testicular cancer....

Citalopram- Citalopram Hydrobromide Solution

Citalopram Oral Solution, USP is indicated for the treatment of depression. The efficacy of Citalopram Oral Solution, USP in the treatment of depression was established in 4-6 week, controlled trials ...

Citalopram- Citalopram Hydrobromide Tablet, Film Coated

Citalopram tablets, USP are indicated for the treatment of depression. The efficacy of citalopram tablets, USP in the treatment of depression was established in 4 to 6 week, controlled trials of outpa...

Cladribine Injection

Cladribine Injection, USP is indicated for the treatment of active Hairy Cell Leukemia as defined by clinically significant anemia, neutropenia, thrombocytopenia or disease-related symptoms....

Clarithromycin 250 Mg- Clarithromycin Tablet, Film Coatedclarithromycin 500 Mg- Clarithromycin Tablet, Film Coated

1.1 Acute Bacterial Exacerbation of Chronic Bronchitis Clarithromycin tablets are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus...

Clarithromycin 500 Mg- Clarithromycin Tablet, Film Coated

1.1 Acute Bacterial Exacerbation of Chronic Bronchitis Clarithromycin tablets are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus...

Clarithromycin Extended Release- Clarithromycin Tablet, Film Coated, Extended Release

To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin extended-release tablets and other antibacterial drugs, clarithromycin extended-release tablets sh...

Clarithromycin Extended-release- Clarithromycin Tablet, Extended Release

1.1 Acute Bacterial Exacerbation of Chronic Bronchitis Clarithromycin tablets, clarithromycin for oral suspension and clarithromycin extended-release tablets are indicated in adults for the treatment ...

Cleocin Hydrochloride- Clindamycin Hydrochloride Capsule

Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strain...

Cleocin- Clindamycin Palmitate Hydrochloride Granule, For Solution

CLEOCIN PEDIATRIC (clindamycin palmitate HCl) is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious in...

Cleocin- Clindamycin Phosphate Cream

CLEOCIN Vaginal Cream 2%, is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, ...

Cleocin- Clindamycin Phosphate Suppository

CLEOCIN Vaginal Ovules are indicated for 3-day treatment of bacterial vaginosis in non-pregnant women. There are no adequate and well-controlled studies of CLEOCIN Vaginal Ovules in pregnant women. NO...

Clevecord (hpc- Hematopoietic Progenitor Cell, Cord Blood Injection, Suspension

CLEVECORD, HPC (Hematopoietic Progenitor Cell), Cord Blood, is an allogeneic cord blood hematopoietic progenitor cell therapy indicated for use in unrelated donor hematopoietic progenitor stem cell tr...

Clinimix E- Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose Injection

CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated....

Clinolipid- Olive Oil And Soybean Oil Injection, Emulsion

CLINOLIPID is indicated in adults for providing a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated...

Clomiphene Citrate Tablet

Clomiphene citrate is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Impediments to achieving pregnancy must be excluded or adequately treated before beginning clomi...

Clonidine Hci Injection, Solution

Clonidine hydrochloride is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone. Epidural clonidine is m...

Clonidine Hydrochloride Extended-release- Clonidine Hydrochloride Tablet, Extended Release

Clonidine hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [s...

Clonidine Hydrochloride Injection, Solution

Clonidine hydrochloride injection is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone. Epidural clon...

Clonidine Hydrochloride Tablet

Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents....

Clonidine Hydrochloride- Clonidine Hydrochloride Tablet

Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents....

Clonidine Hydrochloride- Clonidine Tablet, Extended Release

Clonidine hydrochloride (HCl) extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medicati...

Clopidogrel- Clopidogrel Bisulfate Tablet, Film Coated

1.1 Acute Coronary Syndrome (ACS) For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], including patients who are to be managed m...

Clopidogrel- Clopidogrel Bisulfate Tablet, Film Coated

1.1 Acute Coronary Syndrome (ACS) Clopidogrel tablets are indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non-ST-segment elevation ACS (unstable angina [UA]/n...

Clorotekal- Chloroprocaine Hydrochloride Injection, Solution

CLOROTEKAL (chloroprocaine hydrochloride) is indicated for intrathecal injection for the production of subarachnoid block (spinal anesthesia) in adults undergoing surgical procedures. Indicated proc...

Cnj-016 (vaccinia Immune Globulin- Human Injection

VIGIV (vaccinia immune globulin intravenous, human) is indicated for the treatment and/or modification of the following conditions: Eczema vaccinatum Progressive vaccinia Severe generaliz...

Coagadex- Coagulation Factor X Human Kit

COAGADEX, Coagulation Factor X (Human), is a plasma-derived human blood coagulation Factor indicated in adults and children with hereditary Factor X deficiency for: Routine prophylaxis to reduce the ...

Colazal- Balsalazide Disodium Capsule

COLAZAL is indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. Limitations of Use Safety and effectiveness of COLAZAL beyond 8 weeks...

Colchicine Capsule

Colchicine capsules are indicated for prophylaxis of gout flares in adults. Limitations of use: The safety and effectiveness of colchicine capsules for acute treatment of gout flares during prophylaxi...

Colchicine Tablet

1.2 Familial Mediterranean Fever (FMF) Colchicine tablets, USP are indicated in adults and children 4 years or older for treatment of familial Mediterranean fever (FMF)....

Colchicine Tablet, Film Coated

1.1 Gout Flares Colchicine Tablets, USP are indicated for prophylaxis and the treatment of acute gout flares. Prophylaxis of Gout Flares:Colchicine Tablets, USP are indicated for prophylaxis of ...

Colcrys- Colchicine Tablet, Film Coated

1.1 Gout Flares COLCRYS (colchicine, USP) tablets are indicated for prophylaxis and the treatment of acute gout flares. Prophylaxis of Gout Flares: COLCRYS is indicated for prophylaxis of go...

Colesevelam Hcl Tablet, Film Coated

1.1 Primary Hyperlipidemia Colesevelam hydrochloride tablets is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyper...

Colesevelam Hydrochloride Powder, For Suspension

1.1 Primary Hyperlipidemia Colesevelam hydrochloride for oral suspension is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with p...

Colesevelam Hydrochloride Tablet

1.1 Primary Hyperlipidemia Colesevelam hydrochloride tablets are indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hype...

Colesevelam Hydrochloride Tablet, Coated

1.1 Primary Hyperlipidemia Colesevelam hydrochloride is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemi...

Collagenase Santyl Ointment

Collagenase Santyl Ointment is indicated for debriding chronic dermal ulcers 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 and severely burned areas. 3, 4, 5, 7, 16, 19, 20, 21...

Colyte- Peg-3350 And Electrolytes Powder, For Solution

Colyte with flavor packs is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination....

Cometriq- Cabozantinib Kitcometriq- Cabozantinib Capsule

COMETRIQ is indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC)....

Complera Access- Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate Tablet, Film Coated

COMPLERA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: as initial therapy in those with no antiretroviral treatm...

Complera- Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate Tablet, Film Coated

COMPLERA , a combination of two nucleoside analog HIV-1 reverse transcriptase inhibitors (NRTIs) (emtricitabine and tenofovir disoproxil fumarate) and one non-nucleoside reverse transcriptase inhibit...

Condylox- Podofilox Gel

Condylox Gel 0.5% is indicated for the topical treatment of anogenital warts (external genital warts and perianal warts). This product is not indicated in the treatment of mucous membrane warts (see P...

Cordcyte- Human Cord Blood Hematopoietic Progenitor Cell Injection, Suspension

CORDCYTE, HPC (Hematopoietic Progenitor Cell), Cord Blood is an allogeneic cord blood hematopoietic progenitor cell therapy indicated for use in unrelated donor hematopoietic progenitor stem cell tran...

Corifact (factor Xiii Concentrate- Human Kit

Corifact is a Factor XIII Concentrate indicated for routine prophylactic treatment and peri-operative management of surgical bleeding in adult and pediatric patients with congenital FXIII deficiency....

Corlanor- Ivabradine Tablet, Film Coatedcorlanor- Ivabradine Solution

1.1 Heart Failure in Adult Patients Corlanor is indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart fai...

Corlopam- Fenoldopam Mesylate Injection, Solutioncorlopam- Fenoldopam Mesylate Injection, Solution

1.1 Adult Patients Fenoldopam is indicated for in-hospital, short-term (up to 48 hours) management of severe hypertension when rapid, but quickly reversible, emergency reduction of blood pressure is ...

Corphedra- Ephedrine Sulfate Injection, Solution

CORPHEDRA is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia....

Cortrosyn- Cosyntropin Injection, Powder, Lyophilized, For Solution

CORTROSYN (cosyntropin) for Injection is intended for use as a diagnostic agent in the screening of patients presumed to have adrenocortical insufficiency. Because of its rapid effect on the adrenal...

Cosentyx- Secukinumab Injection

1.1 Plaque Psoriasis COSENTYX is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. 1.2 ...

Cosmegen- Dactinomycin Injection, Powder, Lyophilized, For Solution

1.1 Wilms Tumor COSMEGEN is indicated for the treatment of adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen. 1.2 Rhabdomyosarcoma COSMEGEN i...

Cosyntropin Injection, Powder, For Solution

Cosyntropin for injection is intended for use as a diagnostic agent in the screening of patients presumed to have adrenocortical insufficiency. Because of its rapid effect on the adrenal cortex it may...

Cosyntropin Injection, Powder, Lyophilized, For Solution

Cosyntropin for Injection is intended for use as a diagnostic agent in the screening of patients presumed to have adrenocortical insufficiency. Because of its rapid effect on the adrenal cortex it may...

Cotellic- Cobimetinib Tablet, Film Coated

COTELLIC is indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib....

Cotton Injection, Solutioncotton Linters Injection, Solutioncotton Seed Injection, Solutionflaxseed Injection, Solutionkapok Injection, Solutionorris Root Injection, Solutionjute Injection, Solutionsisal Injection, Solution

Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts...

Cotton Injection, Solutioncotton Linters Injection, Solutioncotton Seed Injection, Solutionflaxseed Injection, Solutionkapok Injection, Solutionorris Root Injection, Solutiontobacco Leaf Injection, Solutionjute Injection, Solutionsisal Injection, Solution

Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts...

Cotton Linters- Cotton Linters

Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic sympto...

Cottonseed Injectioncultivated Oat Pollen- Avena Sativa Injectioncurvularia- Curvularia Lunata Injectioncypress, Arizona Pollen- Cupressus Arizonica Injectiondandelion Pollen- Taraxacum Officinale Injectiondate Palm Pollen- Phoenix Dactylifera Injectiondes .......ctioncocklebur Pollen- Xanthium Commune Injectioncockroach, American- Periplaneta Americana Injectioncockroach, German- Blattella Germanica Injectioncommon Sage Pollen- Artemisia Tridentata Injectioncorn Pollen Pollen- Zea Mays Injectioncotton Linters Injection

Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in ...

Coumadin- Warfarin Sodium Tablet

COUMADIN is indicated for: Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE). Prophylaxis and treatment of thromboembolic complications associated with atria...

Covaryx- Estrogens, Esterified And Methyltestosterone Tablet, Coatedcovaryx Hs- Estrogens, Esterified And Methyltestosterone Tablet, Coated

COVARYXT and COVARYX H.S. are indicated in the treatment of Moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evid...

Cresemba- Isavuconazonium Sulfate Capsulecresemba- Isavuconazonium Sulfate Injection, Powder, Lyophilized, For Solution

1.1 Invasive Aspergillosis CRESEMBA is an azole antifungal indicated for patients 18 years of age and older for the treatment of invasive aspergillosis [see Clinical Studies (14.1) and Clinical Pha...

Cricket Injection, Solution

FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. T...

Crixivan- Indinavir Sulfate Capsule

CRIXIVAN in combination with antiretroviral agents is indicated for the treatment of HIV infection. This indication is based on two clinical trials of approximately 1 year duration that demonstrated: ...

Crofab- Ovine Crotalidae Venoms Immune Fab Injection, Powder, Lyophilized, For Solution

CROFAB is indicated for the management of adult and pediatric patients with North American crotalid envenomation. The term crotalid is used to describe the Crotalinae subfamily (formerly known as Crot...

Cromolyn Sodium Solution

Cromolyn sodium inhalation solution USP is a prophylactic agent indicated in the management of patients with bronchial asthma. In patients whose symptoms are sufficiently frequent to require a continu...

Cromolyn Sodium Solution, Concentrate

Cromolyn Sodium Oral Solution, Concentrate is indicated in the management of patients with mastocytosis. Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomi...

Cromolyn Sodium Solution/ Drops

Cromolyn Sodium Ophthalmic Solution USP, 4% is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis....

Cubicin Rf- Daptomycin Injection, Powder, Lyophilized, For Solution

1.1 Complicated Skin and Skin Structure Infections (cSSSI) CUBICIN RF is indicated for the treatment of adult and pediatric patients (1 to 17 years of age) with complicated skin and skin structure i...

Cubicin- Daptomycin Injection, Powder, Lyophilized, For Solution

1.1 Complicated Skin and Skin Structure Infections (cSSSI) CUBICIN is indicated for the treatment of adult and pediatric patients (1 to 17 years of age) with complicated skin and skin structure infe...

Curosurf- Poractant Alfa Suspension

CUROSURF (poractant alfa) Intratracheal Suspension is indicated for the rescue treatment of Respiratory Distress Syndrome (RDS) in premature infants. CUROSURF reduces mortality and pneumothoraces ...

Cutaquig- Immunoglobulin G Solution

CUTAQUIG (Immune Globulin Subcutaneous (Human) - hipp) is a 16.5% immune globulin solution for subcutaneous infusion (IGSC), indicated as replacement therapy for primary humoral immunodeficiency (PI) ...

Cuvitru (immune Globulin Subcutaneous- Human Injection, Solution

CUVITRU is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Solution indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and ...

Cycloset- Bromocriptine Mesylate Tablet

1.1 Type 2 Diabetes Mellitus CYCLOSET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 1.2 Important Limitations of Use CYCLOSET...

Cyclosporine Capsule

Kidney, Liver, and Heart Transplantation Cyclosporine Capsules USP (Modified) are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine Caps...

Cyclosporine Capsule, Gelatin Coated

Cyclosporine capsules, USP (NON-MODIFIED) are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. It is always to be used with adrenal corticosteroids....

Cyclosporine Capsule, Liquid Filled

Cyclosporine Capsules, USP are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. It is always to be used with adrenal corticosteroids. The drug may ...

Cyclosporine Injection, Solution

Cyclosporine is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. It is always to be used with adrenal corticosteroids. The drug may also be used in ...

Cyclosporine Modified- Cyclosporine Capsule, Liquid Filled

Kidney, Liver, and Heart Transplantation Cyclosporine Capsules USP MODIFIED are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine Capsul...

Cyclosporine Solution

Kidney, Liver, and Heart Transplantation Cyclosporine Oral Solution USP MODIFIED is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine Or...

Cyklokapron- Tranexamic Acid Injection, Solution

CYKLOKAPRON Injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following t...

Cymbalta- Duloxetine Hydrochloride Capsule, Delayed Release

1.1 Major Depressive DisorderCymbalta is indicated for the treatment of major depressive disorder (MDD). The efficacy of Cymbalta was established in four short term and one maintenance trial in adul...

Cyramza- Ramucirumab Solution

1.1 Gastric Cancer CYRAMZA , as a single agent or in combination with paclitaxel, is indicated for the treatment of patients with advanced or metastatic, gastric or gastro-esophageal junction (GEJ) ...

Cystadane- Betaine Powder, For Solution

Cystadane (betaine anhydrous for oral solution) is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood levels. Included within the category of homocystinuria ...

Cystadane- Betaine, Anhydrous Powder, For Solution

Cystadane (betaine anhydrous for oral solution) is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood levels. Included within the category of homocystinuria are defi...

Cystagon- Cysteamine Bitartrate Capsule

CYSTAGON is indicated for the management of nephropathic cystinosis in children and adults....

Cystaran- Cysteamine Hydrochloride Solution

CYSTARAN is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis....

Cytogam- Human Cytomegalovirus Immune Globulin Liquid

Cytomegalovirus Immune Globulin Intravenous (Human) is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas and heart. In transplan...

Cytomel- Liothyronine Sodium Tablet

1.1 Hypothyroidism CYTOMEL is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. 1.2 Pituitary Thyr...

Cytotec- Misoprostol Tablet

Cytotec (misoprostol) is indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin) induced gastric ulcers in patients at high risk of complications from gast...

Cytovene Iv- Ganciclovir Sodium Injection, Powder, Lyophilized, For Solution

1.1 Treatment of CMV Retinitis CYTOVENE-IV is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency synd...

D

D.h.e. 45- Dihydroergotamine Mesylate Injection, Solution

D.H.E. 45 (dihydroergotamine mesylate) Injection, USP is indicated for the acute treatment of migraine headaches with or without aura and the acute treatment of cluster headache episodes....

Dactinomycin Injection, Powder, Lyophilized, For Solution

1.1 Wilms Tumor Dactinomycin for injection is indicated for the treatment of adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen. 1.2 Rhabdomyo...

Daklinza- Daclatasvir Tablet

DAKLINZA is indicated for use with sofosbuvir, with or without ribavirin, for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infection [see Dosage and Administ...

Dalfampridine Tablet, Extended Release

Dalfampridine extended-release tablets are indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed [see Clini...

Dalfampridine Tablet, Film Coated, Extended Release

Dalfampridine Extended-release Tablets are indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed [see Clini...

Daliresp- Roflumilast Tablet

DALIRESP is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of Use DA...

Dalvance- Dalbavancin Injection, Powder, For Solution

1.1 Acute Bacterial Skin and Skin Structure Infections DALVANCE (dalbavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structu...

Danazol Capsule

Endometriosis Danazol capsules USP are indicated for the treatment of endometriosis amenable to hormonal management. Fibrocystic Breast Disease Most cases of symptomatic fibrocystic breast disease ...

Dandelion- Taraxacum Officinale Pollen Injection, Solutionfire Ant- Solenopsis Invicta Injection, Solutionmelaleuca- Melaleuca Quinquenervia Pollen Injection, Solutionnettle- Urtica Dioica Pollen Injection, Solutionshagbark Hickory- Carya Ovata Pollen Injection, Solution

Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the o...

Dantrium- Dantrolene Sodium Capsule

In Chronic Spasticity Dantrium is indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders (e.g., spinal cord injury, stroke, cerebral palsy, or m...

Dantrium- Dantrolene Sodium Capsule

In Chronic Spasticity: Dantrium is indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders (e.g., spinal cord injury, stroke, cerebral palsy, or...

Dantrium- Dantrolene Sodium Injection

Dantrium Intravenous is indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in...

Dantrium- Dantrolene Sodium Injection

Dantrium Intravenous is indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in...

Dantrolene Injection, Powder, For Solution

Dantrolene Sodium for Injection is indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermi...

Dantrolene Sodium Capsule

In Chronic Spasticity Dantrolene sodium capsules are indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders (e.g., spinal cord injury, stroke, c...

Dapsone Gel

Dapsone gel, 5%, is indicated for the topical treatment of acne vulgaris....

Dapsone Tablet

Dermatitis herpetiformis: (D.H.) Leprosy: All forms of leprosy except for cases of proven Dapsone resistance....

Daptacel (corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated), Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated), Bordetella Pertussis Toxoid Antigen (glutaraldehyde Inactivated), Bordetella Pertussis Filamentous Hemagglutinin Antigen- Formaldehyde Inactivated, Bordetella Pertussis Pertactin Antigen, And Bordetella Pertussis Fimbriae 2/3 Antigen Injection, Suspension

DAPTACEL is a vaccine indicated for active immunization against diphtheria, tetanus and pertussis as a five-dose series in infants and children 6 weeks through 6 years of age (prior to seventh birth...

Daptomycin Injection, Powder, Lyophilized, For Solution

1.1 Complicated Skin and Skin Structure Infections (cSSSI) Daptomycin for injection is indicated for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused ...

Daraprim- Pyrimethamine Tablet

Treatment of Toxoplasmosis: DARAPRIM is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination....

Darzalex- Daratumumab Injection, Solution, Concentrate

DARZALEX is indicated for the treatment of adult patients with multiple myeloma: in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem ...

Daunorubicin Hydrochloride Injection

Daunorubicin hydrochloride in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and f...

Daunorubicin Hydrochloride Injection, Solution

Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of ad...

Daurismo- Glasdegib Tablet, Film Coated

DAURISMO is indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are 75 years old or who have comorbidities th...

Ddavp- Desmopressin Acetate Injection

Hemophilia A DDAVP Injection 4 mcg/mL is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5%. DDAVP will often maintain hemostasis in patients with hemo...

Ddavp- Desmopressin Acetate Spray

DDAVP Nasal Spray is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and pediatric patients 4 years of age and older. Limitations of Use: DDAV...

Ddavp- Desmopressin Acetate Tablet

Central Diabetes Insipidus DDAVP Tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydips...

Deferasirox Tablet, For Suspension

1.1 Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload) Deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload due to b...

Deferiprone Tablet

Deferiprone tablets are indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate. Approval is based on a reduc...

Deferoxamine Mesylate Injection, Powder, Lyophilized, For Solution

Deferoxamine mesylate for injection, USP, is indicated for the treatment of acute iron intoxication and of chronic iron overload due to transfusion-dependent anemias. Acute Iron Intoxication Deferoxam...

Deferoxamine- Deferoxamine Mesylate Injection, Powder, Lyophilized, For Solution

Deferoxamine mesylate is indicated for the treatment of acute iron intoxication and of chronic iron overload due to transfusion-dependent anemias. Acute Iron Intoxication Deferoxamine mesylate is a...

Definity- Perflutren Injection, Suspension

Activated DEFINITY (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the deli...

Delstrigo- Doravirine, Lamivudine, And Tenofovir Disoproxil Fumarate Tablet, Film Coated

DELSTRIGO is indicated as a complete regimen for the treatment of HIV-1 infection in adult patients: with no prior antiretroviral treatment history, OR to replace the current antiretroviral regime...

Demeclocycline Hydrochloride Tablet

To reduce the development of drug-resistant bacteria and maintain the effectiveness of demeclocycline hydrochloride tablets and other antibacterial drugs, demeclocycline hydrochloride tablets should b...

Demeclocycline Hydrochloride Tablet, Film Coated

Demeclocycline hydrochloride tablets USP is indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below: Rocky Mountain spotted fev...

Demeclocycline Hydrochloride- Demeclocycline Tablet

Demeclocycline HCl tablets, USP are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below: Rocky Mountain spotted fever, typhu...

Demser- Metyrosine Capsule

DEMSER is indicated in the treatment of patients with pheochromocytoma for: 1. Preoperative preparation of patients for surgery 2. Management of patients when surgery is contraindicated 3. Chronic tre...

Depo-testosterone- Testosterone Cypionate Injection, Solution

DEPO-Testosterone Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congen...

Desferal- Deferoxamine Mesylate Injection, Powder, Lyophilized, For Solution

Desferal is indicated for the treatment of acute iron intoxication and of chronic iron overload due to transfusion-dependent anemias. Acute Iron Intoxication Desferal is an adjunct to, and not a sub...

Desflurane Liquid

1.1 Induction of Anesthesia Desflurane, USP, Liquid for Inhalation is indicated as an inhalation agent for induction of anesthesia for inpatient and outpatient surgery in adults. Desflurane, USP, Liq...

Desmopressin Acetate Injection

Hemophilia A Desmopressin acetate injection 4 mcg/mL is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5%. Desmopressin acetate will often maintain he...

Desmopressin Acetate Injection, Solution

Hemophilia A: Desmopressin Acetate Injection 4 mcg/mL is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5%. Desmopressin acetate will often maintain h...

Desmopressin Acetate Solution

Desmopressin acetate nasal solution 0.01% (nasal spray) is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and pediatric patients 4 years of age...

Desmopressin Acetate Spray

Desmopressin acetate nasal solution 0.01% (nasal spray) is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and pediatric patients 4 years of age...

Desmopressin Acetate- Desmopressin Acetate Injection, Solution

Hemophilia A: Desmopressin Acetate Injection 4 mcg/mL is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5%.Desmopressin acetate injection will often m...

Desoxyn- Methamphetamine Hydrochloride Tablet

Attention Deficit Disorder with Hyperactivity: DESOXYN tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, education...

Desvenlafaxine Extended-release- Desvenlafaxine Tablet, Extended Release

Desvenlafaxine Extended-Release Tablets are indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)]....

Desvenlafaxine Succinate Tablet, Extended Release

Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)]....

Desvenlafaxine- Desvenlafaxine Succinate Tablet, Extended Release

Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)]....

Dexmedetomidine Hcl Injection

1.1 Procedural Sedation Dexmedetomidine hydrochloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures....

Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride Injection

1.2 Procedural Sedation Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures....

Dexmedetomidine Hydrochloride Injection

1.1 Intensive Care Unit Sedation Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment...

Dexmedetomidine Hydrochloride Injection, Solution

1.1 Procedural Sedation Dexmedetomidine Hydrochloride Injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures....

Dexmedetomidine Hydrochloride Injection, Solution, Concentratedexmedetomidine Hydrochloride Injection

1.1 Intensive Care Unit Sedation Dexmedetomidine Hydrochloride Injectionis indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care set...

Dexmedetomidine- Dexmedetomidine Hydrochloride Injection, Solution, Concentrate

1.2 Procedural Sedation Dexmedetomidine hydrochloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures....

Dexrazoxane Hydrochloride- Dexrazoxane Kit

Dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a c...

Dexrazoxane Injection, Powder, Lyophilized, For Solution

Dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a c...

Dexrazoxane- Dexrazoxane For Injection Injection, Powder, Lyophilized, For Solution

Dexrazoxane for Injection is indicated for reducing the incid ence and severity of cardiomyopathy associated with doxorubicin ad m inistration in wo men with metastatic breast cancer who have receive...

Dexrazoxane- Dexrazoxane Hydrochloride Injection, Solution

Dexrazoxane for Injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a c...

Dextran 75 Injection, Powder, Lyophilized, For Solution

Technetium Tc99m Dextran by intravenous administration is indicated as a cardiac blood pool imaging agent and as an adjunct in the diagnosis of pericardial effusion, ventricular aneurysm, or GI Bleed...

Dextrose And Electrolyte No. 48- Sodium Lactate, Potassium Chloride, Magnesium Chloride, Monobasic Potassium Phosphate, Sodium Chloride And Dextrose Monohydrate Injection

5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is indicated as a source of water, electrolytes, and calories or as an alkalinizing agent....

Diclofenac Sodium And Misoprostol Delayed-release- Diclofenac Sodium And Misoprostol Tablet, Delayed Release

Carefully consider the potential benefits and risks of diclofenac sodium and misoprostol delayed-release tablets and other treatment options before deciding to use diclofenac sodium and misoprostol de...

Diclofenac Sodium And Misoprostol Tablet, Delayed Release

Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-i...

Diclofenac Sodium And Misoprostol Tablet, Film Coated

Diclofenac sodium/misoprostol is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal u...

Diethylpropion Hcl Controlled-release- Diethylpropion Hydrochloride Tablet

Diethylpropion hydrochloride is indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an...

Diethylpropion Hcl Controlled-release- Diethylpropion Hydrochloride Tabletdiethylpropion Hcl Immediate-release- Diethylpropion Hydrochloride Tablet

Diethylpropion hydrochloride is indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an...

Dificid- Fidaxomicin Tablet, Film Coated

1.1 Clostridium difficile-Associated Diarrhea DIFICID is a macrolide antibacterial drug indicated in adults ( 18 years of age) for treatment of Clostridium difficile-associated diarrhea (CDAD). 1...

Digifab- Ovine Digoxin Immune Fab Injection, Powder, For Solution

DigiFab is indicated for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose, including: Known suicidal or accidental...

Digitek- Digoxin Tablet

1.1 Heart Failure in Adults DIGITEK (digoxin tablets) is indicated for the treatment of mild to moderate heart failure in adults. DIGITEK (digoxin tablets) increases ...

Digox- Digoxin Tablet

Heart Failure: Digoxin is indicated for the treatment of mild to moderate heart failure. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by exerci...

Digoxin Injection

1.1 Heart Failure in Adults Digoxin is indicated for the treatment of mild to moderate heart failure in adults. Digoxin increases left ventricular ejection fraction and improves heart failure sympto...

Digoxin Injection, Solution

1.1 Heart Failure in Adults Digoxin injection is indicated for the treatment of mild to moderate heart failure in adults. Digoxin injection increases left ventricular ejection fraction and improves he...

Digoxin Solution

1.1 Heart Failure in Adults Digoxin Oral Solution USP is indicated for the treatment of mild to moderate heart failure. Digoxin increases left ventricular ejection fraction and improves heart failure ...

Dihydroergotamine Mesylate Injection

Dihydroergotamine Mesylate Injection, USP is indicated for the acute treatment of migraine headaches with or without aura and the acute treatment of cluster headache episodes....

Dihydroergotamine Mesylate Injection, Solution

Dihydroergotamine Mesylate Injection, USP is indicated for the acute treatment of migraine headaches with or without aura and the acute treatment of cluster headache episodes....

Dihydroergotamine Mesylate Spray

Dihydroergotamine Mesylate Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura. Dihydroergotamine Mesylate Nasal Spray is not intended for the prophylactic ther...

Dilantin Infatabs- Phenytoin Tablet, Chewable

DILANTIN INFATABS are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring d...

Dilantin- Extended Phenytoin Sodium Capsule

DILANTIN is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery....

Dilantin- Phenytoin Sodium Capsule, Extended Release

DILANTIN is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery....

Dilantin-125- Phenytoin Suspension

DILANTIN is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures....

Dilatrate Sr- Isosorbide Dinitrate Capsule, Extended Release

dilatrate -SR sustained release capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of actio...

Dilatrate-sr- Isosorbide Dinitrate Capsule, Extended Release

dilatrate -SR sustained release capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of controlled-release oral isosorbide dinitrate is no...

Diphenoxylate Hydrochloride And Atropine Sulfate Solution

Diphenoxylate hydrochloride and atropine sulfate is effective as adjunctive therapy in the management of diarrhea....

Diphenoxylate Hydrochloride And Atropine Sulfate Tablet

Diphenoxylate hydrochloride and atropine sulfate tablets are effective as adjunctive therapy in the management of diarrhea....

Diphtheria And Tetanus Toxoids Adsorbed (corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated) And Clostridium Tetani Toxoid Antigen- Formaldehyde Inactivated Injection, Suspension

Diphtheria and Tetanus Toxoids Adsorbed is a vaccine indicated for active immunization against diphtheria and tetanus. Diphtheria and Tetanus Toxoids Adsorbed is approved for use in children from 6 we...

Diprivan Injection, Emulsion

DIPRIVAN Injectable Emulsion is an IV sedative-hypnotic agent that can be used as described in the table below. Table 3. Indications for DIPRIVAN Injectable Emulsion Indication Approved Pa...

Diprivan- Propofol Injection, Emulsion

DIPRIVAN is an IV general anesthetic and sedation drug that can be used as described in the table below. Table 3. Indications for DIPRIVAN Indication Approved Patient Population Initiation...

Disulfiram Tablet

Disulfiram Tablets USP are an aid in the management of selected chronic alcohol patients who want to remain in a state of enforced sobriety so that supportive and psychotherapeutic treatment may be ap...

Docetaxel Anhydrous Injection, Solution

1.1 Breast Cancer Docetaxel injection is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. Docetaxel injection in combinati...

Docetaxel Injection

1.1 Breast Cancer Docetaxel injection is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. Docetaxel injection in combi...

Docetaxel Injection, Solution

1.1 Breast Cancer Docetaxel Injection is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. Docetaxel Injection in combinati...

Docetaxel Injection, Solution, Concentrate

1.1 Breast Cancer Docetaxel Injection is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. Docetaxel Injection in combinat...

Docetaxel Injection, Solution, Concentratedocetaxel Injection, Solution, Concentrate

1.1 Breast Cancer Docetaxel Injection is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. Docetaxel Injection in combinati...

Docetaxel- Docetaxel Anhydrous Injection, Solution

1.1 Breast Cancer Docetaxel Injection is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. Docetaxel Injection in combinati...

Donepezil Hydrochloride 5 Mg- Donepezil Hydrochloride Tablet, Film Coated

Donepezil hydrochloride is indicated for the treatment of dementia of the Alzheimer s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease....

Donepezil Hydrochloride 5 Mg- Donepezil Hydrochloride Tablet, Film Coateddonepezil Hydrochloride 10 Mg- Donepezil Hydrochloride Tablet, Film Coated

Donepezil hydrochloride is indicated for the treatment of dementia of the Alzheimer s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease....

Donepezil Hydrochloride- Donepezil Tablet, Film Coated

Donepezil hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease....

Donepezil- Donepezil Hydrochloride Tablet

Donepezil hydrochloride tablet, USP is indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease....

Donepezil- Donepezil Hydrochloride Tabletdonepezil Hydrochloride Tablet

Donepezil hydrochloride tablet, USP is indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease....

Dopram- Doxapram Hydrochloride Injection

Postanesthesia When the possibility of airway obstruction and/or hypoxia have been eliminated, doxapram may be used to stimulate respiration in patients with drug-induced postanesthesia respiratory d...

Doribax- Doripenem Powder, For Solution

1.1 Complicated Intra-Abdominal Infections DORIBAX (doripenem for injection) is indicated as a single agent for the treatment of complicated intra-abdominal infections caused by ...

Doryx Mpc- Doxycycline Hyclate Tablet, Delayed Release

1.1 Rickettsial Infections DORYX MPC is indicated for treatment of Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. 1...

Doryx- Doxycycline Hyclate Capsule, Delayed Release Pellets

To reduce the development of drug-resistant bacteria and maintain the effectiveness of DORYX and other antibacterial drugs, DORYX should be used only to treat or prevent infections that are proven or ...

Doryx- Doxycycline Hyclate Tablet, Delayed Release

To reduce the development of drug-resistant bacteria and maintain the effectiveness of DORYX and other antibacterial drugs, DORYX should be used only to treat or prevent infections that are proven or ...

Dotarem- Gadoterate Meglumine Injection

DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (...

Dovato- Dolutegravir Sodium And Lamivudine Tablet, Film Coated

DOVATO is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known substitutions ...

Doxapram Hydrochloride Injection

Postanesthesia When the possibility of airway obstruction and/or hypoxia have been eliminated, doxapram may be used to stimulate respiration in patients with drug-induced postanesthesia respiratory de...

Doxercalciferol Capsule

Doxercalciferol capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and adult patients with CKD on dialysis...

Doxercalciferol Injection

Doxercalciferol injection is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis....

Doxercalciferol Injection, Solution

Doxercalciferol injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis....

Doxil- Doxorubicin Hydrochloride Injection, Suspension, Liposomal

1.1 Ovarian Cancer DOXIL is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. 1.2 AIDS-Related Kaposi's Sarcoma...

Doxorubicin Hydrochloride Injectable, Liposomal

1.1 Ovarian Cancer Doxorubicin hydrochloride liposome injection is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemothera...

Doxorubicin Hydrochloride Injection, Powder, Lyophilized, For Solution

1.1 Adjuvant Breast Cancer Doxorubicin hydrochloride, USP is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resecti...

Doxorubicin Hydrochloride Injection, Solution

1.1 Adjuvant Breast Cancer Doxorubicin HCl is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary b...

Doxorubicin Hydrochloride- Doxorubicin Injection, Powder, Lyophilized, For Solutiondoxorubicin Hydrochloride Injection, Powder, Lyophilized, For Solution

1.1 Adjuvant Breast Cancer Doxorubicin HCl for injection is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resectio...

Doxy 100- Doxycycline Injection, Powder, Lyophilized, For Solution

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxy-cycline for Injection, USP and other antibacterial drugs, Dooxycycline for Injection, USP should be used onl...

Doxy 100- Tm Doxycycline Injection, Powder, Lyophilized, For Solution

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline for Injection, USP and other antibacterial drugs, Doxycycline for Injection, USP should be used only ...

Doxycyclate Hyclate- Doxycycline Hyclate Capsule

To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Capsules, USP and other antibacterial drugs, Doxycycline Hyclate Capsules, USP should be used on...

Draximage Dtpa- Kit For The Preparation Of Technetium Tc 99m Pentetate Injection, Powder, Lyophilized, For Solution

DRAXIMAGE DTPA, after radiolabeling with Technetium Tc 99m, is indicated for 1.1 Brain Imaging Brain imaging in adults by intravenous administration. 1.2 Renal Scintigraphy Renal visualization,...

Drisdol- Ergocalciferol Capsule, Liquid Filled

DRISDOL is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia....

Dromelate- Dihydroergotamine Mesylate Injection, Solution

Dihydroergotamine Mesylate Injection, USP is indicated for the acute treatment of migraine headaches with or without aura and the acute treatment of cluster headache episodes....

Dronabinol Capsule

Dronabinol capsules are indicated in adults for the treatment of: anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS). nausea and vomiting associated with...

Droperidol Injection, Solution

Droperidol injection is indicated to reduce the incidence of nausea and vomiting associated with surgical and diagnostic procedures....

Duavee- Conjugated Estrogens/bazedoxifene Tablet, Film Coated

DUAVEE is indicated in women with a uterus for: 1.1 Treatment of Moderate to Severe Vasomotor Symptoms Associated with Menopause 1.2 Prevention of Postmenopausal Osteoporosis 1.3 Importa...

Ducord- Human Cord Blood Hematopoietic Progenitor Cell Solution

DUCORD, HPC (Hematopoietic Progenitor Cell), Cord Blood, is an allogeneic cord blood hematopoietic progenitor cell therapy indicated for use in unrelated donor hematopoietic progenitor stem cell trans...

Duetact- Pioglitazone And Glimepiride Tablet

DUETACT is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and sulfonylurea or who hav...

Duodote- Atropine And Pralidoxime Chloride Kit

DuoDote is indicated for the treatment of poisoning by organophosphorus nerve agents as well as organophosphorus insecticides in adults and pediatric patients weighing more than 41 kg (90 pounds)....

Dupixent- Dupilumab Injection, Solution

DUPIXENT is indicated for the following diseases: 1.1 Atopic Dermatitis DUPIXENT is indicated for the treatment of patients aged 12 years and older with moderate-to-severe atopic dermatitis whose di...

Dutasteride And Tamsulosin Hydrochloride Capsule

1.1 Benign Prostatic Hyperplasia (BPH) Treatment Dutasteride and Tamsulosin Hydrochloride capsules are indicated for the treatment of symptomatic BPH in men with an enlarged prostate. 1.2 Limitatio...

Dutasteride And Tamsulosin Hydrochloride- Dutasteride And Tamsulosin Hydrochloride Capsules Capsule

1.1 Benign Prostatic Hyperplasia (BPH) Treatment Dutasteride and tamsulosin hydrochloride capsules are indicated for the treatment of symptomatic BPH in men with an enlarged prostate. 1.2 Limitatio...

Dutasteride Capsule

1.1 Monotherapy Dutasteride capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: improve symptoms, reduce the risk of acute...

Dutasteride Capsule, Liquid Filled

1.1 Monotherapy Dutasteride capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: improve symptoms, reduce the risk of acute ...

Duzallo- Lesinurad And Allopurinol Tablet, Film Coated

DUZALLO , a combination of lesinurad, a uric acid transporter 1 (URAT1) inhibitor, and allopurinol, a xanthine oxidase inhibitor, is indicated for the treatment of hyperuricemia associated with gout ...

Dyazide- Hydrochlorothiazide And Triamterene Capsule

This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. DYAZIDE is indicated for th...

Dyrenium- Triamterene Capsule

Dyrenium (triamterene) is indicated in the treatment of edema associated with congestive heart failure, cirrhosis of the liver and the nephrotic syndrome; steroid-induced edema, idiopathic edema and e...

Dysport- Botulinum Toxin Type A Injection, Powder, Lyophilized, For Solution

1.1 Cervical Dystonia DYSPORT is indicated for the treatment of adults with cervical dystonia. 1.2 Glabellar Lines DYSPORT is indicated for the temporary improvement in the appearance of moderate t...

E

Edarbi- Azilsartan Kamedoxomil Tablet

Edarbi is an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular ev...

Edarbyclor- Azilsartan Kamedoxomil And Chlorthalidone Tablet

Edarbyclor contains an angiotensin II receptor blocker (ARB) and a thiazide-like diuretic and is indicated for the treatment of hypertension, to lower blood pressure. Edarbyclor may be used in patient...

Edex- Alprostadil Injection, Powder, Lyophilized, For Solution

edex is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology....

Edluar- Zolpidem Tartrate Tablet

Edluar (zolpidem tartrate) sublingual tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation [see Clinical Studies (14)]. The clinical trial...

Edurant- Rilpivirine Hydrochloride Tablet, Film Coated

EDURANT , in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-na ve patients 12 year...

Eemt- Estrogens, Esterified And Methyltestosterone Tablet, Coatedeemt Hs- Estrogens, Esterified And Methyltestosterone Tablet, Coated

ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH are indicated in the treatment of: Moderate to severe vasomotor symptoms associa...

Efavirenz Capsule

Efavirenz capsules in combination with other antiretroviral agents are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients at least...

Efavirenz Tablet

Efavirenz in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients at least 3 months ...

Efavirenz Tablet, Film Coated

Efavirenz tablets in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients at least...

Effer-k 10 Meq Unflavored- Potassium Bicarbonate Tablet, Effervescenteffer-k 10 Meq Cherry Vanilla- Potassium Bicarbonate Tablet, Effervescenteffer-k 20 Meq Unflavored- Potassium Bicarbonate Tablet, Effervescenteffer-k 20 Meq Orange Cream- Potassium Bicarbonate Tablet, Effervescent

For therapeutic use in patients with hypokalemia with or without metabolic alkalosis; in chronic digitalis intoxication; and in patients with hypokalemic familial periodic paralysis. For prevention of...

Egg Yolk Injection, Solutionflounder- Southern Flounder Injection, Solutiongarlic Injection, Solutionhoneydew- Honeydew Melon Injection, Solutionlamb Injection, Solutionlemon Injection, Solutionlettuce Injection, Solutionlima Bean Injection, Solutionlobster- American Lobster Injection, Solutiongoats Milk- Goat Milk Injection, Solutioncows Milk- Cow Milk Injection, Solutionmushroom- Cultivated Mushroom Injection, Solutionmustard- Mustard Seed Injection, Solutionoat Grain- Oat Injection, Solutionolive- Black Olive Injection, Solution

These products are for diagnostic use only. Diagnostic allergenic extracts are indicated for use in skin testing to establish the clinical relevance of specific allergens to which the patient has been...

Egrifta- Tesamorelin Kit

EGRIFTA is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. Limitations of Use: Long-term cardiovascular safety of EGRIFTA has not been establish...

Elaprase- Idursulfase Solution, Concentrate

ELAPRASE is indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). ELAPRASE has been shown to improve walking capacity in patients 5 years and older. In patients 16 months to ...

Elelyso- Taliglucerase Alfa Injection, Powder, Lyophilized, For Solution

ELELYSO is indicated for the treatment of patients with a confirmed diagnosis of Type 1 Gaucher disease....

Elestat- Epinastine Hydrochloride Solution/ Drops

ELESTAT ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis....

Eletriptan Hydrobromide Tablet, Film Coated

Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine has been established. I...

Eletriptan- Eletriptan Hydrobromide Tablet, Film Coated

Eletriptan is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine has been established. If a patient has no r...

Elidel- Pimecrolimus Cream

ELIDEL Cream, 1% is a calcineurin inhibitor immunosuppressant indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immu...

Eligard- Leuprolide Acetate Kit

ELIGARD is indicated for the palliative treatment of advanced prostate cancer....

Elimite- Permethrin Cream

ELIMITE (permethrin) 5% Cream is indicated for the treatment of infestation with Sarcoptesscabiei (scabies)....

Eliquis- Apixaban Tablet, Film Coated

1.1 Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation ELIQUIS (apixaban) is indicated to reduce the risk of stroke and systemic embolism in patient...

Eliquis- Apixaban Tablet, Film Coatedeliquis 30-day Starter Pack- Apixaban Kit

1.1 Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation ELIQUIS (apixaban) is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvu...

Elitek- Rasburicase Kit

Elitek is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy ...

Ella- Ulipristal Acetate Tablet

ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. ella is not in...

Elliotts B- Sodium Cation, Sodium Bicarbonate, Anhydrous Dextrose, Magnesium Sulfate, Potassium Chloride, Calcium Chloride, Sodium Phosphate Injection

Elliotts B Solution is indicated as a diluent for the intrathecal administration of methotrexate sodium and cytarabine for the prevention or treatment of meningeal leukemia or lymphocytic lymphoma....

Elmiron- Pentosan Polysulfate Sodium Capsule, Gelatin Coated

ELMIRON (pentosan polysulfate sodium) is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis....

Emadine- Emedastine Difumarate Solution/ Drops

EMADINE (emedastine difumarate ophthalmic solution) 0.05% is indicated for the temporary relief of the signs and symptoms of allergic conjunctivitis....

Emend- Aprepitant Capsule

1.1 Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) EMEND1, in combination with other antiemetic agents, is indicated for the: prevention of acute and delayed nausea and vomiting associ...

Emend- Aprepitant Capsuleemend- Aprepitant Kit

1.1 Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) EMEND, in combination with other antiemetic agents, is indicated for the: prevention of acute and delayed nausea and vomiting associa...

Emend- Aprepitant Capsuleemend- Aprepitant Kitemend- Aprepitant Powder, For Suspension

EMEND for oral suspension, in combination with other antiemetic agents, is indicated in patients 6 months of age and older for the prevention of: acute and delayed nausea and vomiting associated wi...

Emend- Fosaprepitant Dimeglumine Injection, Powder, Lyophilized, For Solution

EMEND for injection, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of: acute and delayed nausea and vomitin...

Empliciti- Elotuzumab Injection, Powder, Lyophilized, For Solution

EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. EMPLICITI is ind...

Emsam- Selegiline Patch

EMSAM (selegiline transdermal system) is a monoamine oxidase inhibitor (MAOI) indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)]....

Emverm- Mebendazole Tablet, Chewable

EMVERM is indicated for the treatment of patients two years of age and older with gastrointestinal infections caused by Ancylostoma duodenale (hookworm), Ascaris lumbricoides (roundworm), Enterobius...

Enbrel- Etanercept Solution

1.1 Rheumatoid Arthritis Enbrel is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical fu...

Enbrel- Etanercept Solutionenbrel- Etanercept Kit

1.1 Rheumatoid Arthritis Enbrel is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical fu...

Endrate- Edetate Disodium, Anhydrous Injection, Solution

Endrate (Edetate Disodium Injection, USP) is indicated in selected patients for the emergency treatment of hypercalcemia and for the control of ventricular arrhythmias associated with digitalis toxici...

Enoxaparin Sodium Injection

1.1 Prophylaxis of Deep Vein Thrombosis Enoxaparin Sodium Injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): in patients undergoing a...

Enoxaparin Sodium Injection, Solution

1.1 Prophylaxis of Deep Vein Thrombosis Enoxaparin sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): in patients undergoing ...

Enoxaparin Sodium Injectionenoxaparin Sodium Injection

1.1 Prophylaxis of Deep Vein Thrombosis Enoxaparin Sodium Injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): in patients undergoing a...

Entacapone Tablet

Entacapone tablets are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose wearing-off in patients with Parkinson s disease (see CLINICAL PHARMACOLOGY, Clinical Studies). ...

Entacapone Tablet, Film Coated

Entacapone tablets USP are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose "wearing-off" in patients with Parkinson's disease (see CLINICAL PHARMACOLOG...

Entresto- Sacubitril And Valsartan Tablet, Film Coated

1.1 Adult Heart Failure ENTRESTO is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV...

Entyvio- Vedolizumab Injection, Powder, Lyophilized, For Solution

1.1 Adult Ulcerative Colitis ENTYVIO (vedolizumab) is indicated for: inducing and maintaining clinical response, inducing and maintaining clinical remission, improving the endoscopic appearance of th...

Envarsus Xr- Tacrolimus Tablet, Extended Release

1.1 Prophylaxis of Organ Rejection in De Novo Kidney Transplant Patients ENVARSUS XR is indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunos...

Eovist- Gadoxetate Disodium Injection, Solution

EOVIST is indicated for intravenous use in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in patients with known or suspected focal liver disease....

Epclusa Access- Velpatasvir And Sofosbuvir Tablet, Film Coated

EPCLUSA is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection [see Dosage and Administration (2.2) and Clinical Studies (14)]:...

Epclusa- Velpatasvir And Sofosbuvir Tablet, Film Coated

EPCLUSA is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection [see Dosage and Administration (2.2) and Clinical Studies (14)]: w...

Ephedrine Sulfate Injection

Ephedrine Sulfate Injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia....

Ephedrine Sulfate Injection, Solution

Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia....

Epinastine Hydrochloride Solution

Epinastine hydrochloride ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis....

Epinastine Hydrochloride Solution/ Drops

Epinastine HCl Ophthalmic Solution 0.05% is indicated for the prevention of itching associated with allergic conjunctivitis....

Epinastine- Epinastine Hydrochloride Solution/ Drops

Epinastine Hydrochloride Ophthalmic Solution is indicated for the prevention of itching associated with allergic conjunctivitis....

Eplerenone Tablet

1.1 Heart Failure Post-Myocardial Infarction Eplerenone tablets are indicated to improve survival of stable patients with symptomatic heart failure with reduced ejection fraction ( 40%) (HFrEF) aft...

Eplerenone Tablet, Film Coated

1.1 Heart Failure Post-Myocardial Infarction Eplerenone is indicated to improve survival of stable patients with symptomatic heart failure with reduced ejection fraction ( 40%) (HFrEF) after an acu...

Epogen- Epoetin Alfa Solution

1.1 Anemia Due to Chronic Kidney Disease Epogen is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis to decre...

Epoprostenol Sodium Injection, Powder, For Solutionsterile Diluent Injection

Epoprostenol sodium for injection is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise capacity. Trials establishing effectiveness included predomi...

Equus Caballus Skin- Horse Epithelia Injection, Solutionceiba Pentandra Fiber- Kapok Injection, Solutionmus Musculus Skin- Mouse Epithelia Injection, Solutionorris- Iris X Germanica Root Injection, Solutionrabbit Injection, Solutionperiplaneta Americana- American Cockroach Injec .......se Dust Injection, Solutionbos Taurus Skin- Cattle Epithelia Injection, Solutioncotton Fiber- Cotton Linters Injection, Solutioncotton Seed- Cottonseed Injection, Solutioncanis Lupus Familiaris Skin- Dog Epithelia Injection, Solutioncavia Porcellus Skin- Guinea Pig Epithelia Injection, Solution

Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal dander, various other inhalants, and in situations where the of...

Eraxis- Anidulafungin Injection, Powder, Lyophilized, For Solution

ERAXIS is indicated for use in adults for the treatment of the following fungal infections listed below. Specimens for fungal culture and other relevant laboratory studies (including histopathology) s...

Erbitux- Cetuximab Solution

1.1 Squamous Cell Carcinoma of the Head and Neck (SCCHN) ERBITUX is indicated: in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carc...

Ergocalciferol Capsule

Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia....

Ergocalciferol Capsule, Liquid Filled

Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia....

Ergomar Sublingual- Ergotamine Tartrate Tablet

Ergomar is indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called "histaminic cephalalgia"....

Ergomar- Ergotamine Tartrate Tablet, Orally Disintegrating

Ergomar is indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or a so-called "histaminic cephalalgia"....

Ergotamine Tartrate And Caffeine Tablet, Film Coated

Ergotamine tartrate and caffeine tablets are indicated as therapy to abort or prevent vascular headache; e.g., migraine, migraine variants or so-called histaminic cephalalgia....

Ergotamine- Ergotamine Tartrate And Caffeine Tablet, Film Coated

Ergotamine Tartrate and Caffeine Indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called histaminic cephalalgia ....

Erivedge- Vismodegib Capsule

ERIVEDGE is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for ...

Erlotinib Hydrochloride Tablet, Film Coated

1.1 Non-Small Cell Lung Cancer (NSCLC) Erlotinib tablets are indicated for: The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth fact...

Erlotinib Tablet, Film Coated

1.1 Non-Small Cell Lung Cancer (NSCLC) Erlotinib tablets are indicated for: The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor rece...

Ertapenem Injection

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ertapenem and other antibacterial drugs, ertapenem should be used only to treat or prevent infections that are pr...

Ertapenem- Ertapenem Sodium Injection

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ertapenem for injection and other antibacterial drugs, Ertapenem for injection should be used only to treat or pr...

Ertapenem- Ertapenem Sodium Injection, Powder, Lyophilized, For Solution

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ertapenem for injection and other antibacterial drugs, ertapenem for injection should be used only to treat or pr...

Erwinaze- Asparaginase Injection, Powder, Lyophilized, For Solution

ERWINAZE (asparaginase Erwinia chrysanthemi) is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have develo...

Erythromycin Ethylsuccinate And Sulfisoxazole Acetyl Granule, For Suspension

For treatment of ACUTE OTITIS MEDIA in children that is caused by susceptible strains of Haemophilus influenzae....

Esbriet- Pirfenidone Capsule

ESBRIET is indicated for the treatment of idiopathic pulmonary fibrosis (IPF)....

Esbriet- Pirfenidone Capsuleesbriet- Pirfenidone Tablet, Coated

ESBRIET is indicated for the treatment of idiopathic pulmonary fibrosis (IPF)....

Escavite D- .beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Thiamine Hydrochloride, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Hydroxocobalamin, Biotin, Calcium Pantothenate, Ferrous Cysteine Glycinate, Magnesium Oxide, Zinc Oxide, Cupric Oxide, And Sodium Fluoride Tablet, Chewable

Escavite D Multi-vitamin with Iron and Fluoride Chewable Tablets is a prescription drug product for the dietary management of the metabolic processes of caries prophylaxis, and provides supplementa...

Escavite Lq- Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, D-, Thiamine Hydrochloride, Riboflavin, Niacin, Pyridoxine Hydrochloride, Cyanocobalamin, Ferric Pyrophosphate, Ferrous Cysteine Glycinate, And Sodium Fluoride Liquid

Supplementation of the diet with nine essential vitamins and iron, and supplementation of the diet with fluoride for caries prophylaxis. The American Academy of Pediatrics recommends that children up ...

Ethambutol Hydrochloride Tablet

Ethambutol hydrochloride is indicated for the treatment of pulmonary tuberculosis. It should not be used as the sole antituberculous drug, but should be used in conjunction with at least one other ant...

Ethambutol- Ethambutol Hydrochloride Tablet, Film Coated

Ethambutol hydrochloride tablets are indicated for the treatment of pulmonary tuberculosis. It should not be used as the sole antituberculous drug, but should be used in conjunction with at least one ...

Ethamolin- Ethanolamine Oleate Injection, Solution

ETHAMOLIN Injection is indicated for the treatment of patients with esophageal varices that have recently bled, to prevent rebleeding. ETHAMOLIN is not indicated for the treatment of patients with eso...

Ethyol- Amifostine Injection, Powder, Lyophilized, For Solution

1.1 Reduction of Cumulative Renal Toxicity with Chemotherapy ETHYOL (amifostine) is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients w...

Etomidate Injection

Etomidate is indicated by intravenous injection for the induction of general anesthesia. When considering use of etomidate, the usefulness of its hemodynamic properties (see CLINICAL PHARMACOLOGY) sho...

Etomidate Injection, Solution

Etomidate Injection is indicated by intravenous injection for the induction of general anesthesia. When considering use of Etomidate Injection, the usefulness of its hemodynamic properties (see CLINIC...

Etomidate- Etomidate Injection Solution

Etomidate Injection, USP is indicated by intravenous injection for the induction of general anesthesia. When considering use of etomidate, the usefulness of its hemodynamic properties (see CLINICAL PH...

Eucrisa- Crisaborole Ointment

EUCRISA is indicated for topical treatment of mild to moderate atopic dermatitis in patients 2 years of age and older....

Euthyrox- Levothyroxine Sodium Tablet

Hypothyroidism EUTHYROX is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyr...

Evarrest- Fibrinogen Human And Human Thrombin Patch

EVARREST is a fibrin sealant patch indicated for use with manual compression as an adjunct to hemostasis in adult patients undergoing surgery, when control of bleeding by conventional surgical techn...

Evicel Fibrin Sealant (human)- Fibrinogen Human And Thrombin Human Kit

EVICEL fibrin sealant (human) is indicated as an adjunct to hemostasis for use in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, or c...

Evista- Raloxifene Hydrochloride Tablet

1.1 Treatment and Prevention of Osteoporosis in Postmenopausal Women EVISTA is indicated for the treatment and prevention of osteoporosis in postmenopausal women [see Clinical Studies (14.1, 14.2)]...

Evithrom- Human Thrombin Liquid

EVITHROM Thrombin, Topical (Human) is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding...

Evotaz- Atazanavir And Cobicistat Tablet

EVOTAZ is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults. Limitations of Use: Use of EVOTAZ in treatment...

Evoxac- Cevimeline Hydrochloride Capsule

Cevimeline is indicated for the treatment of symptoms of dry mouth in patients with Sj gren s Syndrome....

Exjade- Deferasirox Tablet, For Suspension

1.1 Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload) Exjade is indicated for the treatment of chronic iron overload due to blood transfusions (transf...

Exondys 51- Eteplirsen Injection

EXONDYS 51 is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping. This indication is appr...

Extavia- Interferon Beta-1b Kit

EXTAVIA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in...

Extended Phenytoin Sodium- Phenytoin Sodium Capsule

Extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or fol...

Extina- Ketoconazole Aerosol, Foam

EXTINA (ketoconazole) Foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Limitations of UseSafety and efficacy of EXTINA F...

Exubera- Insulin Humanexubera- Insulin Human Aerosol, Powder

EXUBERA is indicated for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia. EXUBERA has an onset of action similar to rapid-acting insulin analogs and has a durat...

Eylea- Aflibercept Injection, Solution

EYLEA is indicated for the treatment of: 1.1 Neovascular (Wet) Age-Related Macular Degeneration (AMD) 1.2 Macular Edema Following Retinal Vein Occlusion (RVO) 1.3 Diabetic Macular Edema (DME) ...

Ezetimibe And Simvastatin Tablet

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercho...

Ezetimibe And Simvastatin Tablet, Film Coated

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercho...

Ezetimibe And Simvastatin- Ezetimibe And Simvastatin Tablet

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercho...

Ezetimibe Tablet

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercho...

F

Fabrazyme- Agalsidase Beta Injection, Powder, Lyophilized, For Solution

Fabrazyme is indicated for use in patients with Fabry disease. Fabrazyme reduces globotriaosylceramide (GL-3) deposition in capillary endothelium of the kidney and certain other cell types....

Fapp Mixture- Aspergillus Flavus Var. Oryzae, Aspergillus Niger Var. Niger, Aspergillus Repens, Aspergillus Terreus, Gibberella Zeae, Penicillium Chrysogenum Var. Chrysogenum, Phoma Exigua Var. Exigua Injection, Solutionmixed Aspergillus- Aspergillus Flavus Var. Oryzae, Aspergillus Niger Var. Niger, Aspergillus Repens, Aspergillus Terreus Injection, Solutionmixed Feathers .......pollen) Injection, Solutionmold Mix 1- Alternaria Alternata, Alternaria Alternata, Cladosporium Sphaerospermum Injection, Solutionmold Mix 1- Alternaria Alternata, Aspergillus Niger, Cladosporium Sphaerospermum Injection, Solutionmold Mix 2- Aureobasidium Pullulans, Curvularia Inaequalis, Fusarium Roseum, Mucor Plumbeus, Phizopus Oryzae Injection, Solution

Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the o...

Fareston- Toremifene Citrate Tablet

FARESTON is an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors....

Farxiga- Dapagliflozin Tablet, Film Coated

FARXIGA (dapagliflozin) is indicated: as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. to reduce the risk of hospitalization for heart f...

Farydak- Panobinostat Capsule

FARYDAK, a histone deacetylase inhibitor, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with multiple myeloma who have received at least 2 prior regimens...

Fasenra- Benralizumab Injection, Solution

FASENRA is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype [see Clinical Studies (14)]. Limitations of use: ...

Faslodex- Fulvestrant Injection

Monotherapy FASLODEX is indicated for the treatment of: Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not...

Feiba- Anti-inhibitor Coagulant Complex Kit

FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for: Control and prevention of bleeding episodes Perioperative management Rou...

Fenofibrate Capsule

1.1 Primary Hypercholesterolemia and Mixed Dyslipidemia Fenofibrate capsules, USP are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), tota...

Fenofibrate Tablet

Treatment of Hypercholesterolemia Fenofibrate tablets are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hyperchole...

Fenofibrate Tablet, Coated

Treatment of Hypercholesterolemia Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated LDL-C, total-C, triglycerides and apo B, and to increase HDL-C in adult patients w...

Fenofibrate Tablet, Film Coated

Treatment of Hypercholesterolemia Fenofibrate tablets, USP are indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides and Apo B, and to increase HDL-C in adult patien...

Fenoglide- Fenofibrate Tablet

Enter section text here 1.1 Hyperlipidemia and Mixed Dyslipidemia Fenoglide is indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides, and Apo B, and to increase H...

Feraheme- Ferumoxytol Injection

Feraheme is indicated for the treatment of iron deficiency anemia (IDA) in adult patients: who have intolerance to oral iron or have had unsatisfactory response to oral iron or who have chronic kidn...

Ferric Subsulfate Solution

Ferric Subsulfate, Aqueous, is a stypic agent used for achieving local hemostasis. In punch biopsies of the full dermis, the time to achieve hemostasis is typically less than 20 seconds.1 One method o...

Ferriprox- Deferiprone Solution

FERRIPROX (deferiprone) is indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate. Approval is based on a ...

Ferriprox- Deferiprone Tablet, Film Coated

FERRIPROX (deferiprone) is indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate. Approval is based on a ...

Ferrlecit- Sodium Ferric Gluconate Complex Injection

Ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receivin...

Fiasp- Insulin Aspart Injection Injection, Solution

FIASP is indicated to improve glycemic control in adults with diabetes mellitus....

Fibryga (fibrinogen- Human Kit

FIBRYGA is a human fibrinogen concentrate indicated for the treatment of acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency, including afibrinogenemia and hypofibr...

Firazyr- Icatibant Acetate Injection, Solution

Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older....

Firdapse- Amifampridine Phosphate Tablet

FIRDAPSE is indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults....

Fire Ant Injection, Solutionhouse Fly Injection, Solutioncockroach American Injection, Solutionhorse Fly Injection, Solutionmosquito Injection, Solutiongerman Cockroach Injection, Solution

Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts...

Fire Ant Injection, Solutionshagbark Hickory Injection, Solutionmixed Aspergillus Injection, Solutionmixed Feathers Injection, Solutionmixed Ragweed Injection, Solution

Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the o...

Fire Ant- Solenopsis Invicta Injection, Solutioncurvularia- Curvularia Inaequalis Injection, Solutionlenscale- Atriplex Lentiformis Injection, Solutionmosquito- Culex Pipiens Injection, Solutionmixed Cockroach- Periplaneta Americana And Blattella Germanica Injection, Solutionmelaleuca- Melaleuca Quinquenervia Injection, Solutionsorrel/dock Mix- Rumex Acetosella And Rumex Crispus Injection, Solution

Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the o...

Firvanq- Vancomycin Hydrochloride Kit

FIRVANQ is indicated for the treatment of Clostridiumdifficile-associated diarrhea in adults and pediatric patients less than 18 years of age. FIRVANQ is also indicated for the treatment of enter...

Flagyl- Metronidazole Capsule

Symptomatic Trichomoniasis. FLAGYL 375 capsules are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate la...

Flagyl- Metronidazole Tablet, Film Coated

Symptomatic Trichomoniasis FLAGYL is indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory proced...

Flaxseed Injection, Solutionjute Injection, Solutionsisal Injection, Solution

Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts...

Flaxseed Injection, Solutiontobacco Leaf Injection, Solutionjute Injection, Solutionsisal Injection, Solution

Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts...

Flebogamma Dif (immune Globulin Intravenous- Human Injection, Solution

Flebogamma 10% DIF is an immune globulin intravenous (human) solution indicated for the treatment of: 1.1 Primary Immunodeficiency (PI) Flebogamma 10% DIF is indicated as replacement therapy in prim...

Flebogamma Dif (immune Globulin- Human Injection, Solution

Flebogamma 5% DIF is an immune globulin intravenous (human) solution indicated in adults and pediatric patients 2 years of age and older for the treatment of primary immunodeficiency (PI), including t...

Flexbumin- Albumin Human Injection, Solution

FLEXBUMIN 5% [Albumin (Human)] is indicated for hypovolemia, hypoalbuminemia and cardiopulmonary bypass surgery. 1.1 Hypovolemia FLEXBUMIN 5% [Albumin (Human)] is indicated for reversing hypovolemia...

Flexbumin- Albumin Human Solution

FLEXBUMIN 25% [Albumin (Human)] is indicated for hypovolemia, hypoalbuminemia, cardiopulmonary bypass surgery, and hemolytic disease of the newborn (HDN). 1.1 Hypovolemia FLEXBUMIN 25% [Albumin (Hum...

Flolan- Epoprostenol Sodium Injection, Powder, Lyophilized, For Solutiondiluent- Water Solution

FLOLAN is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise capacity. Trials establishing effectiveness included predominantly (97%) patients with ...

Flucytosine Capsule

Flucytosine Capsules, USP are indicated only in the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus.Candida: Septicemia, endocarditis and urinary system in...

Flumazenil Injection

Adult Patients Flumazenil injection is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained wi...

Flumazenil Injection, Solution

Adult Patients Flumazenil Injection, USP is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maint...

Flumazenil- Flumazenil Injection

Adult Patients Flumazenil injection, USP is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintain...

Fluorescein Sodium And Benoxinate Hydrochloride Solution/ Drops

For procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent such as tonometry, gonioscopy, removal of corneal foreign bodies and other short corneal or conjun...

Fluorescite- Fluorescein Sodium Injection, Solution

FLUORESCITE Injection 10% is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature....

Fluress- Fluorescein Sodium And Benoxinate Hydrochloride Solution/ Drops

For procedures requiring a disclosing agent in combination with an anesthetic agent such as tonometry, gonioscopy, removal of corneal foreign bodies and other short corneal or conjunctival procedures....

Flurox (fluorescein Sodium 2.5mg (0.25%), Benoxinate Hydrochloride 4mg- 0.4% Solution

For procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent such as tonometry, gonioscopy, removal of corneal foreign bodies and other short corneal or conjun...

Flutamide Capsule

Flutamide capsules are indicated for use in combination with LHRH-agonists for the management of locally confined Stage B 2-C and Stage D 2metastatic carcinoma of the prostate....

Fml-s- Fluorometholone And Sulfacetamide Sodium Suspension

FML-S ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of b...

Follistim Aq- Follitropin Injection, Solution

Follistim AQ (follitropin beta injection) Cartridge is indicated: In Women for: 1.1 Induction of Ovulation and Pregnancy in Anovulatory Infertile Women in Whom the Cause of Infertility is Function...

Folotyn- Pralatrexate Injection

FOLOTYN is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is based on overall response rate. Clinical benefit such as improvemen...

Fondaparinux Sodium Injection

1.1 Prophylaxis of Deep Vein Thrombosis Fondaparinux sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): in patients undergoi...

Fondaparinux Sodium Injection, Solution

1.1 Prophylaxis of Deep Vein Thrombosis Fondaparinux sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): in patients undergoing...

Food - Plant Source, Soybean Glycine Soja- Soybean Glycine Soja Injection, Solutionfood - Plant Source, Strawberry Fragaria Chiloensis- Strawberry Fragaria Chiloensis Injection, Solutionfood - Plant Source, String Bean Mix- String Bean Mix Injection, Solutionfood - Plant Source, Tomato Nicotiana Spp.- Tomato Nicotiana Spp. Injection, Solutionfood - Plant Source, Walnut, Black Juglans Nigra- Walnut, Black Juglans Nigra Injection, Solutionfood - Plant Source, Yeast, Baker Saccharomyces Cerevisiae- Yeast, Baker Saccharomyces Cerevisiae Injection, Solutionfood - Plant Source, Yeast, Brewer Saccharomyces Cerevisiae- Yeast, Brewer Saccharomyces Cerevisiae Injection, Solutioninsects Whole Body Cockroach, American Periplaneta Americana Injection, Solutioninsects Whole Body Cockroach, German Blatella Germanica Injection, Solutioninsects Whole Body Cockroach Mix Injection, Solutioninsects Whole Body, Fire Ant Mix Injection, Solution

20,21,22,23Allergenic extracts are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific environmental allergens. The sele...

Food - Plant Source, Yeast, Baker Saccharomyces Cerevisiae- Yeast, Baker Saccharomyces Cerevisiae Injection, Solutionfood - Plant Source, Yeast, Brewer Saccharomyces Cerevisiae- Yeast, Brewer Saccharomyces Cerevisiae Injection, Solutioninsects Whole Body Cockroach Mix Injection, Solutioninsects Whole Body, Ant, Fire Solenopsis Invicta- Ant, Fire Solenopsis Invicta Injection, Solutioninsects Whole Body, Ant, Fire Solenopsis Richteri- Ant, Fire Solenopsis Richteri Injection, Solutioninsects Whole Body, Fire Ant Mix Injection, Solutionmolds - Alternaria/hormodendrum Mix Injection, Solutionmolds - Mold Mix 10 Injection, Solutionmolds - Mold Mix 4 Injection, Solutionmolds - Trichophyton Mix Injection, Solutionmolds, Penicillium Mix Injection, Solutionmolds, Rusts And Smuts, Alternaria Tenuis- Alternaria Tenuis Injection, Solutionmolds, Rusts And Smuts, Aspergillus Fumigatus- Aspergillus Fumigatus Injection, Solutionmolds, Rusts And Smuts, Aspergillus Niger- Aspergillus Niger Injection, Solutionmolds, Rusts And Smuts, Botrytis Cinerea- Botrytis Cinerea Injection, Solution

Certain diagnostics carry labeling which states Allergenic Extract for Diagnostic Use Only. Data to support the therapeutic use of products labeled with this statement have not been established. 14In ...

Fortamet- Metformin Hydrochloride Tablet, Extended Release

FORTAMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus....

Fortamet- Metformin Hydrochloride Tablet, Film Coated, Extended Release

FORTAMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus....

Forteo- Teriparatide Injection, Solution

1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture FORTEO is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as...

Fortical- Calcitonin Salmon Spray, Metered

1.1 Treatment of Postmenopausal Osteoporosis Fortical nasal spray is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. Fracture reduction efficac...

Fosamprenavir Calcium Tablet, Film Coated

Fosamprenavir calcium tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. The following points should be conside...

Fosaprepitant Injection, Powder, Lyophilized, For Solution

Fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat cours...

Fosaprepitant- Fosaprepitant Dimeglumine Injection, Powder, Lyophilized, For Solution

Fosaprepitant for Injection, in combination with other antiemetic agents, is indicated in adults for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat co...

Foscavir- Foscarnet Sodium Injection

CMV Retinitis: FOSCAVIR is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Combination therapy with FOSCAVIR and ganciclovir is indicated for p...

Fragmin- Dalteparin Sodium Injection

1.1 Prophylaxis of Ischemic Complications in Unstable Angina and Non-Q-Wave Myocardial Infarction FRAGMIN Injection is indicated for the prophylaxis of ischemic complications in unstable angina and no...

Frova- Frovatriptan Succinate Tablet, Film Coated

FROVA is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use Use only if a clear diagnosis of migraine has been established. If a patient has no response ...

Frovatriptan Succinate Tablet, Film Coated

Frovatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use Use only if a clear diagnosis of migraine has been established. If ...

Frovatriptan- Frovatriptan Succinate Tablet, Film Coated

Frovatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use Use only if a clear diagnosis of migraine has been established. If ...

Fulphila- Pegfilgrastim Injection

1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Fulphila is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid mal...

Fulvestrant Injection

Monotherapy Fulvestrant injection is indicated for the treatment of: Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopa...

Fulvestrant Injection, Solution

Monotherapy Fulvestrant Injection is indicated for the treatment of: Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausa...

Furadantin- Nitrofurantoin Suspension

Furadantin is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible stra...

Fusilev- Levoleucovorin Injection, Powder, Lyophilized, For Solutionfusilev- Levoleucovorin Injection, Solution

Fusilev is a folate analog. Fusilev rescue is indicated after high-dose methotrexate therapy in osteosarcoma. Fusilev is also indicated to diminish the toxicity and counteract the effects of impair...

Fuzeon- Enfuvirtide Kit

FUZEON in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretr...

Fycompa- Perampanel Tabletfycompa- Perampanel Suspension

1.1 Partial-Onset Seizures FYCOMPA is indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older. 1....

G

Gabazolpidem-5- Zolpidem Tartrate, Choline Kit

1. INDICATIONS AND USAGEZolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown ...

Gadavist- Gadobutrol Injection

1.1 Magnetic Resonance Imaging (MRI) of the Central Nervous System (CNS) Gadavist is indicated for use with magnetic resonance imaging (MRI) in adult and pediatric patients, including term neonates, t...

Gamastan (immune Globulin- Human Injection, Solutiongamastan (immune Globulin- Human Injection, Solution

GAMASTAN is a human immune globulin indicated for: 1.1 Hepatitis A GAMASTAN is indicated for prophylaxis following exposure to hepatitis A.(1,2) The prophylactic value of GAMASTAN is greatest when...

Gammagard Liquid (immune Globulin Infusion- Human Injection, Solution

GAMMAGARD LIQUID is indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older. This includes, but is not limited to, common ...

Gammagard S/d (immune Globulin Intravenous- Human Kit

Primary Immunodeficiency (PI) GAMMAGARD S/D is indicated for the treatment of primary immunodeficiency (PI) associated with defects in humoral immunity, in adults and children two years and older. Thi...

Gammaked (immune Globulin- Human Injection

GAMMAKED is an immune globulin injection (human) 10% liquid that is indicated for the treatment of: 1.1 Primary Humoral Immunodeficiency (PI) GAMMAKED is indicated for treatment of primary humoral...

Gammaplex- Human Immunoglobulin G Solution

1.1 Primary Humoral Immunodeficiency (PI) GAMMAPLEX 5% is an Immune Globulin Intravenous (Human), 5% Liquid indicated for replacement therapy in primary humoral immunodeficiency (PI) in adults and ped...

Gamunex-c (immune Globulin- Human Injection

GAMUNEX-C is an immune globulin injection (human) 10% liquid that is indicated for the treatment of: 1.1 Primary Humoral Immunodeficiency (PI) GAMUNEX-C is indicated for treatment of primary humora...

Ganciclovir Capsule

Ganciclovir capsules are indicated for the prevention of CMV disease in solid organ transplant recipients and in individuals with advanced HIV infection at risk for developing CMV disease. Ganciclovir...

Ganciclovir Injection, Powder, Lyophilized, For Solution

1.1 Treatment of CMV Retinitis Ganciclovir is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency synd...

Ganciclovir Injection, Solution

1.1 Treatment of CMV Retinitis GANCICLOVIR INJECTION is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adult patients, including patients with acquired immunodefic...

Ganciclovir- Ganciclovir Sodium Injection, Powder, Lyophilized, For Solution

1.1 Treatment of CMV Retinitis Ganciclovir for Injection, USP is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adult patients, including patients with acquired i...

Ganciclovir- Ganciclovir Sodium Injection, Solution

1.1 Treatment of CMV Retinitis Ganciclovir Injection is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adult patients, including patients with acquired immunodefi...

Ganirelix Acetate Injection, Solution

Ganirelix acetate injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation....

Gardasil (human Papillomavirus Quadrivalent- Types 6, 11, 16, And 18 Vaccine, Recombinant Injection, Suspension

1.1 Girls and Women GARDASIL is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV) types included in t...

Gardasil 9- Human Papillomavirus 9-valent Vaccine, Recombinant Injection, Suspension

1.1 Girls and Women GARDASIL 9 is a vaccine indicated in girls and women 9 through 45 years of age for the prevention of the following diseases: Cervical, vulvar, vaginal, and anal cancer caused by...

Gattex- Teduglutide Injection, Powder, Lyophilized, For Solutiongattex- Teduglutide Kit

GATTEX is indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support....

Gazyva- Obinutuzumab Injection, Solution, Concentrate

1.1 Chronic Lymphocytic Leukemia (CLL) GAZYVA, in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia [see Clinical Studies...

Gemfibrozil Tablet

Gemfibrozil Tablets, USP are indicated as adjunctive therapy to diet for: 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who pres...

Gemfibrozil- Gemfibrozil Tablet

Gemfibrozil tablets are indicated as adjunctive therapy to diet for: Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a r...

Genotropin- Somatropin Kit

1.1 Pediatric Patients GENOTROPIN is indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone. GENOTROPIN is indicated for ...

Genvoya- Elvitegravir, Cobicistat, Emtricitabine, And Tenofovir Alafenamide Tablet

GENVOYA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral treatment history or to replace the ...

Gilenya- Fingolimod Hcl Capsule

GILENYA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in...

Gilotrif- Afatinib Tablet, Film Coated

1.1 EGFR Mutation-Positive, Metastatic Non-Small Cell Lung Cancer GILOTRIF is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have n...

Gintuit- Allogeneic Cultured Keratinocytes And Fibroblasts In Bovine Collagen Cellular Sheet

GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) is an allogeneic cellularized scaffold product indicated for topical (non-submerged) application to a surgically created ...

Glassia- .alpha.1-proteinase Inhibitor Human Injection, Solution

GLASSIA, is an Alpha1-Proteinase Inhibitor (Human), indicated for chronic augmentation and maintenance therapy in individuals with clinically evident emphysema due to severe hereditary deficiency of A...

Gleevec- Imatinib Mesylate Tablet

1.1 Newly Diagnosed Philadelphia Positive Chronic Myeloid Leukemia (Ph+ CML) Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (...

Gleolan- Aminolevulinic Acid Hydrochloride Powder, For Solution

Gleolan is indicated in patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery...

Glimepiride Tablet

Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (...

Glimepiride- Glimepiride Tablet

Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1) ]. Limitations of Use...

Glipizide And Metformin Hcl Tablet, Film Coated

Glipizide and Metformin HCl Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus....

Glipizide And Metformin Hydrochloride Tablet

Glipizide/metformin HCl tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus....

Glipizide And Metformin Hydrochloride Tablet, Film Coated

Glipizide and metformin hydrochloride tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus....

Glipizide And Metformin Hydrochloride Tablet, Film Coatedglipizide And Metformin Hydrochloride Tablet, Film Coated

Glipizide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus....

Gloperba- Colchicine Solution

GLOPERBA (colchicine) Oral Solution is indicated for prophylaxis of gout flares in adults. Limitations of use: The safety and effectiveness of GLOPERBA for acute treatment of gout flares during ...

Glucag0n- Glucagon Kit Kit

For the treatment of severe hypoglycemia: Glucagon is indicated as a treatment for severe hypoglycemia (low blood sugar) which may occur in patients with diabetes mellitus. Because patients with type ...

Glucagen Hypokit- Glucagon Hydrochloride Kit

1.1 Treatment of severe hypoglycemia GlucaGen is used to treat severe hypoglycemic (low blood sugar) reactions which may occur in patients with diabetes mellitus treated with insulin. Because GlucaGe...

Glucagen- Glucagon Hydrochloride Kitglucagen- Glucagon Hydrochloride Injection, Powder, For Solution

1.1 Treatment of severe hypoglycemia GlucaGen is used to treat severe hypoglycemic (low blood sugar) reactions which may occur in patients with diabetes mellitus treated with insulin. Because GlucaGen...

Glucagon Injection, Powder, Lyophilized, For Solutionglucagon Kit

Glucagon for Injection is indicated for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract. Limitations of Use: Glucago...

Glucagon Kit

For the treatment of severe hypoglycemia: Glucagon is indicated as a treatment for severe hypoglycemia (low blood sugar) which may occur in patients with diabetes mellitus. Because patients with type...

Glucagon- Glucagon Injection, Powder, Lyophilized, For Solutionglucagon Kit

Glucagon for Injection is indicated for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract. Limitations of Use: ...

Glyset- Miglitol Tablet, Film Coated

GLYSET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus....

Glyxambi- Empagliflozin And Linagliptin Tablet, Film Coated

GLYXAMBI is a combination of empagliflozin and linagliptin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both emp...

Gonal-f Rff Redi-ject- Follitropin Injection, Solution

1.1 Induction of Ovulation and Pregnancy in Oligo-Anovulatory Women in whom the Cause of Infertility is Functional and Not Due to Primary Ovarian Failure. Prior to initiation of treatment with Gonal-f...

Gonal-f Rff- Follitropin Alfa Kit

Gonal-f RFF (follitropin alfa for injection) is indicated for the induction of ovulation and pregnancy in the oligo-anovulatory infertile patient in whom the cause of infertility is functional and n...

Gonal-f- Follitropin Alfa Kit

Women Gonal-f (follitropin alfa for injection) is indicated for the induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of infertility is functional and not d...

Gonitro- Nitroglycerin Powder

GONITRO is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease....

Granisetron Hydrochloride Injection

Granisetron Hydrochloride Injection is a serotonin-3 (5-HT3) receptor antagonist indicated for: The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cance...

Granisetron- Granisetron Hydrochloride Injection, Solution

Granisetron Hydrochloride Injection, USP is a serotonin-3 (5-HT3) receptor antagonist indicated for: The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic...

Granix- Tbo-filgrastim Injection, Solution

GRANIX is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated ...

Gris-peg- Griseofulvin Tablet, Film Coated

Gris-PEG (griseofulvin ultramicrosize) is indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athlete s foot), tinea cruris (ringwor...

Griseofulviin (microsize) (griseofulvin- Microsize Suspension

Major indications for Griseofulvin Oral Suspension are: Griseofulvin inhibits the growth of those genera of fungi that commonly cause ringworm infections of the hair, skin, and nails, such as: Note: P...

Griseofulvin Suspension

Major indications for Griseofulvin Oral Suspension are: Tinea capitis (ringworm of the scalp) Tinea corporis (ringworm of the body) Tinea pedis (athlete's foot) Tinea unguium (onychomycosis; ringw...

Griseofulvin Tablet

Griseofulvin is indicated for the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair and nails, namely: Tinea corporis Tinea pedis Tinea cruris Tinea bar...

Griseofulvin Tablet, Film Coated

Griseofulvin ultramicrosize is indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groi...

Grisofulvin Suspension

Griseofulvin oral suspension is indicated for the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair and nails, namely: Tinea corporis Tinea pedis Tinea c...

Guanidine Hydrochloride Tablet

Guanidine is indicated for the reduction of the symptoms of muscle weakness and easy fatigability associated with the myasthenic syndrome of Eaton-Lambert. It is not indicated for treating myasthenia ...

Gvoke Pfs 0.5 Mg Pre-filled Syringe- Glucagon Injection, Solution Injection, Solutiongvoke Pfs 1 Mg Pre-filled Syringe- Glucagon Injection, Solution Injection, Solutiongvoke Hypopen 1 Mg Auto-injector- Glucagon Injection, Solution Injection, Solutiongvoke Hypopen 0.5 Mg Auto-injector- Glucagon Injection, Solution Injection, Solution

GVOKE is an antihypoglycemic agent indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above. ( 1)...

H

Haegarda C1 Esterase Inhibitor Subcutaneous (human)- Human C1-esterase Inhibitor Kit

HAEGARDA is a plasma-derived concentrate of C1 Esterase Inhibitor (Human) (C1-INH) indicated for routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients....

Haldol Decanoate- Haloperidol Decanoate Injection

HALDOL Decanoate 50 and HALDOL Decanoate 100 are indicated for the treatment of schizophrenic patients who require prolonged parenteral antipsychotic therapy....

Haloperidol Decanoate Injection

Haloperidol decanoate injection, 50 mg/mL and haloperidol decanoate injection, 100 mg/mL are indicated for the treatment of schizophrenic patients who require prolonged parenteral antipsychotic therap...

Haloperidol- Haloperidol Lactate Injection

Haloperidol Injection, USP is indicated for use in the treatment of schizophrenia. Haloperidol Injection, USP is indicated for the control of tics and vocal utterances of Tourette's Disorder....

Haloperidol- Haloperidol Lactate Injectionhaloperidol- Haloperidol Lactate Injection

Haloperidol Injection, USP is indicated for use in the treatment of schizophrenia. Haloperidol Injection, USP is indicated for the control of tics and vocal utterances of Tourette's Disorder....

Haloperidol- Haloperidol Lactate Solution, Concentrate

Haloperidol oral solution is indicated for use in the management of manifestations of psychotic disorders. Haloperidol oral solution is indicated for the control of tics and vocal utterances of Touret...

Harvoni Access- Ledipasvir And Sofosbuvir Tablet, Film Coated

Adult Patients: HARVONI is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) : HARVONI is indicated for the treatment of adult patients...

Harvoni- Ledipasvir And Sofosbuvir Tablet, Film Coatedharvoni- Ledipasvir And Sofosbuvir Tablet, Film Coatedharvoni- Ledipasvir And Sofosbuvir Pellet

HARVONI is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) [see Dosage and Administration (2.2 and 2.3) and Clinical Studies ...

Havrix- Hepatitis A Vaccine Injection, Suspension

HAVRIX is indicated for active immunization against disease caused by hepatitis A virus (HAV). HAVRIX is approved for use in persons 12 months of age and older. Primary immunization should be admin...

Hectorol- Doxercalciferol Injection, Solution

HECTOROL capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and adult patients with CKD on dialysis. HECTO...

Helixate Fs- Antihemophilic Factor, Recombinant Kit

Helixate FS is a recombinant antihemophilic factor indicated for: On-demand treatment and control of bleeding episodes in adults and children with hemophilia A. Perioperative management of...

Hemabate- Carboprost Tromethamine Injection, Solution

HEMABATE Sterile Solution is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following con...

Hemacord- Human Cord Blood Hematopoietic Progenitor Cell Injection

HEMACORD, HPC (Hematopoietic Progenitor Cell), Cord Blood, is an allogeneic cord blood hematopoietic progenitor cell therapy indicated for use in unrelated donor hematopoietic progenitor stem cell tra...

Hematopoietic Progenitor Cells, Cord Blood- Human Cord Blood Hematopoietic Progenitor Cell Liquid

HPC (hematopoietic progenitor cells), Cord Blood is an allogeneic cord blood hematopoietic progenitor cell therapy indicated for use in unrelated donor hematopoietic progenitor stem cell transplantati...

Hematopoietic Progenitor Cells, Cord Blood- Human Cord Blood Hematopoietic Progenitor Cell Solution

Hematopoietic Progenitor Cell (HPC), Cord Blood, is an allogeneic cord blood hematopoietic progenitor cell therapy indicated for use in unrelated donor hematopoietic progenitor stem cell transplantati...

Hemetab- Folic Acid, Cyanocobalamin, Iron Sucrose, Heme Iron Polypeptide Tablet

HemeTab is a prescription iron supplement indicated for use in improving the nutritional status of iron deficiency....

Hemofil M- Antihemophilic Factor Human Kit

HEMOFIL M is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes. HEMOFIL M is not indicated in von Willebrand's disease....

Hepagam B (hepatitis B Immune Globulin Intravenous- Human Injection

HepaGam B [Hepatitis B immune globulin intravenous (Human)] is an intravenous immune globulin indicated for the following: 1.1 Prevention of Hepatitis B recurrence following liver transplant in HBsA...

Hepagam B (hepatitis B Immune Globulin- Human Solution

HepaGam B [Hepatitis B immune globulin intravenous (Human)] is an intravenous immune globulin indicated for the following: 1.1 Prevention of Hepatitis B recurrence following liver transplant in HBs...

Heparin Sodium And Dextrose- Heparin Sodium Injection, Solution

HEPARIN SODIUM IN 5% DEXTROSE INJECTION is indicated for: Prophylaxis and treatment of venous thrombosis and pulmonary embolism; Prophylaxis and treatment of thromboembolic complications associated w...

Heparin Sodium In Dextrose- Heparin Sodium And Dextrose Injection

Heparin sodium is indicated for: Prophylaxis and treatment of venous thrombosis and pulmonary embolism; Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation...

Heparin Sodium In Sodium Chloride Injection

Heparin Sodium Injection in 0.9% Sodium Chloride at the concentration of 2 USP units/mL is indicated as an anticoagulant to maintain catheter patency....

Heparin Sodium In Sodium Chloride- Heparin Sodium Injection, Solution

Heparin Sodium in Sodium Chloride Injection at a concentration of 2 units/mL is indicated as an anticoagulant to maintain catheter patency....

Heparin Sodium Injection

Heparin Sodium Injection is indicated for: Prophylaxis and treatment of venous thrombosis and pulmonary embolism Prevention of postoperative deep venous thrombosis and pulmonary embolism in ...

Heparin Sodium Injectionheparin Sodium Injection

Heparin Sodium Injection is indicated for: Prophylaxis and treatment of venous thrombosis and pulmonary embolism; Prevention of postoperative deep venous thrombosis and pulmonary embolism in patient...

Heparin Sodium- Heparin Sodium Injection, Solution

Heparin Sodium Injection is indicated for: Anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension; (In a low-dose regimen) for prevention of postoperative deep venou...

Heparin Sodium- Heparin Sodium Injection, Solution

Heparin sodium is indicated for: Prophylaxis and treatment of venous thromboembolism and pulmonary embolism; Atrial fibrillation with embolization; Treatment of acute and chronic consumptive coagulo...

Heplisav-b (hepatitis B Vaccine- Recombinant Adjuvanted Injection, Solution

HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. HEPLISAV-B is approved for use in adults 18 years of age and older....

Herceptin Hylecta- Trastuzumab And Hyaluronidase-oysk Injection, Solution

1.1 Adjuvant Breast Cancer HERCEPTIN HYLECTA is indicated for adjuvant treatment of adults with HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Cl...

Herceptin- Trastuzumab Kitherceptin- Trastuzumab Injection, Powder, Lyophilized, For Solution

1.1 Adjuvant Breast Cancer Herceptin is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies (14.1...

Herzuma- Trastuzumab Kitherzuma- Trastuzumab Injection, Powder, Lyophilized, For Solution

1.1 Adjuvant Breast Cancer HERZUMA is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies (14.1)]...

Hetlioz- Tasimelteon Capsule

HETLIOZ is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24)....

Hicon- Sodium Iodide I 131 Solution

HICON is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma....

Hizentra- Human Immunoglobulin G Liquid

HIZENTRA is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of the following conditions: 1.1 Primary Immunodeficiency (PI) HIZENTRA is indicated as replacement...

Homatropine Hydrobromide Ophthalmic- Homatropine Hydrobromide Solution

A moderately long-acting mydriatic and cycloplegic for cycloplegic refraction and in the treatment of inflammatory conditions of the uveal tract. For pre and postoperative states when mydriasis is re...

Homatropine Hydrobromide- Homatropine Hydrobromide Ophthalmic Solution

A moderately long-acting mydriatic and cycloplegic for cycloplegic refraction and in the treatment of inflammatory conditions of the uveal tract. For pre and postoperative states when mydriasis is req...

Honey Bee Hymenoptera Venom Multidose Injection, Powder, Lyophilized, For Solutionwhite Faced Hornet Hymenoptera Venom Multidose Injection, Powder, Lyophilized, For Solutionwasp Hymenoptera Venom Multidose Injection, Powder, Lyophilized, For Solutionyellow Jacket Hymenoptera Venom Multidose Injection, Powder, Lyophilized, For Solutionmixed Vespid Hymenoptera Venom Multidose Injection, Powder, Lyophilized, For Solution

Insect stings may induce a wide range of allergic symptoms in sensitive patients. A normal sting response is initial burning or stinging pain that may be intense and last several minutes to an hour or...

Honey Bee Hymenoptera Venom Multidose Injection, Powder, Lyophilized, For Solutionwhite Faced Hornet Hymenoptera Venom Multidose Injection, Powder, Lyophilized, For Solutionyellow Hornet Hymenoptera Venom Multidose Injection, Powder, Lyophilized, For Solutionwasp Hymenoptera Venom Multidose Injection, Powder, Lyophilized, For Solutionyellow Jacket Hymenoptera Venom Multidose Injection, Powder, Lyophilized, For Solutionmixed Vespid Hymenoptera Venom Multidose Injection, Powder, Lyophilized, For Solution

Insect stings may induce a wide range of allergic symptoms in sensitive patients. A normal sting response is initial burning or stinging pain that may be intense and last several minutes to an hour or...

Honey Bee Hymenoptera Venom Venomil Diagnostic Kithoney Bee Hymenoptera Venom Venomil Maintenance Kitwhite Faced Hornet Hymenoptera Venom Venomil Diagnostic Kitwhite Faced Hornet Hymenoptera Venom Venomil Maintenance Kityellow Hornet Hymenoptera Venom Venomil Diagnostic Kityellow Hornet Hymenoptera Venom Venomil Maintenance Kitwasp Hymenoptera Venom Venomil Diagnostic Kitwasp Hymenoptera Venom Venomil Maintenance Kityellow Jacket Hymenoptera Venom Venomil Diagnostic Kityellow Jacket Hymenoptera Venom Venomil Maintenance Kitmixed Vespid Hymenoptera Venom Venomil Maintenance Kit

Insect stings may induce a wide range of allergic symptoms in sensitive patients. A normal sting response is initial burning or stinging pain that may be intense and last several minutes to an hour or...

House Dust Injection, Solution

Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts...

House Dust Injection, Solutionalmond- Almond Food Injection, Solutionapple- Apple Food Injection, Solutionapricot Injection, Solutionasparagus Injection, Solutionavocado Injection, Solutionbanana Injection, Solutionbarley (barley Food .......> Fraxinus Velutina Pollen (arizona Ash) Injection, Solution Amaranthus Retroflexus Pollen (rough Pigweed Redroot) Injection, Solution Liquidambar Styraciflua Pollen (sweetgum Non Stock) Injection, Solution Juglans Nigra Pollen (walnut Black Pollen) Injection, Solution Salix Nigra Pollen- Black Willow Injection, Solution [alk-abello, Inc.]fraxinus Velutina Pollen- Arizona Ash Injection, Solutionamaranthus Retroflexus Pollen- Rough Pigweed Redroot Injection, Solutionliquidambar Styraciflua Pollen- Sweetgum Non Stock Injection, Solutionjuglans Nigra Pollen- Walnut Black Pollen Injection, Solutionsalix Nigra Pollen- Black Willow Injection, Solution

These products are for diagnostic use only. Diagnostic allergenic extracts are indicated for use in skin testing to establish the clinical relevance of specific allergens to which the patient has bee...

Hpc, Cord Blood Injection

HPC (Hematopoietic Progenitor Cell), Cord Blood, is an allogeneic cord blood hematopoietic progenitor cell therapy indicated for use in unrelated donor hematopoietic progenitor cell transplantation pr...

Humalog Kwikpen- Insulin Lispro Injection, Solution

HUMALOG is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus....

Humalog Mix50/50- Insulin Lispro Injection, Suspensionhumalog Mix50/50 Kwikpen- Insulin Lispro Injection, Suspension

HUMALOG Mix50/50 is indicated to improve glycemic control in patients with diabetes mellitus. Limitations of Use: The proportions of rapid-acting and intermediate-acting insulins in HUMALOG Mix50/...

Humalog Mix75/25- Insulin Lispro Injection, Suspension

Humalog Mix75/25, a mixture of 75% insulin lispro protamine suspension and 25% insulin lispro injection, (rDNA origin), is indicated in the treatment of patients with diabetes mellitus for the control...

Humalog Mix75/25- Insulin Lispro Injection, Suspensionhumalog Mix75/25 Kwikpen- Insulin Lispro Injection, Suspension

HUMALOG Mix75/25 is indicated to improve glycemic control in patients with diabetes mellitus. Limitations of Use: The proportions of rapid-acting and intermediate-acting insulins in HUMALOG Mix75/...

Humalog- Insulin Lispro Injection, Solution

HUMALOG is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus....

Humalog- Insulin Lispro Injection, Solutionhumalog Kwikpen- Insulin Lispro Injection, Solution

HUMALOG is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus....

Humalog- Insulin Lispro Injection, Solutionhumalog Kwikpen- Insulin Lispro Injection, Solutionhumalog Junior Kwikpen- Insulin Lispro Injection, Solution

HUMALOG is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus....

Humalog- Insulin Lispro Injection, Solutionhumalog Pen- Insulin Lispro Injection, Solutionhumalog Cartridge- Insulin Lispro Injection, Solution

HUMALOG is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus....

Humatrope- Somatropin Kit

1.1 Pediatric Patients Growth Hormone Deficiency Humatrope is indicated for the treatment of pediatric patients who have growth failure due to inadequate secretion of endogenous growth hormone ...

Humira- Adalimumab Kit

1.1 Rheumatoid Arthritis HUMIRA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adul...

Humira- Adalimumab Kithumira- Adalimumab Injection, Solution

1.1 Rheumatoid Arthritis HUMIRA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adul...

Humulin 70/30- Insulin Human Injection, Suspension

HUMULIN 70/30 is a fixed ratio premix recombinant human insulin formulation indicated to improve glycemic control in adult patients with diabetes mellitus....

Humulin 70/30- Insulin Human Injection, Suspensionhumulin 70/30 Kwikpen- Insulin Human Injection, Suspension

HUMULIN 70/30 is a fixed ratio insulin formulation indicated to improve glycemic control in adult patients with diabetes mellitus....

Hydase- Hyaluronidase Injection, Solution

1.1 Absorption and Dispersion of Injected Drugs Hydase (hyaluronidase injection) is indicated as an adjuvant to increase the absorption and dispersion of other injected drugs. 1.2 Hypodermocly...

Hydroxychloroquine Sulfate Tablet

Malaria Hydroxychloroquine Sulfate Tablets are indicated for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax. Hydroxychloroquine Sulfate Tablets are i...

Hydroxychloroquine Sulfate Tablet, Film Coated

Malaria Hydroxychloroquine sulfate tablets are indicated for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax. Hydroxychloroquine sulfate ...

Hydroxychloroquine Sulfate- Hydroxychloroquine Sulfate Tablet

Hydroxychloroquine sulfate tablets are indicated for the suppressive treatment and treatment of acute attacks of malaria due to Plasmodium vivax, P. malariae, P. ovale and susceptible strains of P. fa...

Hydroxychloroquine Sulfate- Hydroxychloroquine Sulfate Tablet, Film Coated

Hydroxychloroquine sulfate tablets, USP are indicated for the suppressive treatment and treatment of acute attacks of malaria due to Plasmodium vivax, P. malariae, P. ovale, and susceptible strains of...

Hylenex Recombinant (hyaluronidase- Human Recombinant Injection, Solution

1.1 Subcutaneous Fluid Administration HYLENEX recombinant is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration. 1.2 Dispersion and Absorption of Injected Drugs H...

Hyophen- Methenamine, Benzoic Acid, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate Tablet

Hyophen tablets are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which a...

Hyperhep B S/d (hepatitis B Immune Globulin- Human Injection

Recommendations on post-exposure prophylaxis are based on available efficacy data and on the likelihood of future HBV exposure for the person requiring treatment. In all exposures, a regimen combining...

Hyperrho S/d Full Dose (rho(d) Immune Globulin- Human Solution

Pregnancy and Other Obstetric Conditions HyperRHO S/D Full Dose is recommended for the prevention of Rh hemolytic disease of the newborn by its administration to the Rho(D) negative mother within 72 h...

Hyperrho S/d Mini-dose (rho(d) Immune Globulin- Human Solution

HyperRHO S/D Mini-Dose is recommended to prevent the isoimmunization of Rho(D) negative women at the time of spontaneous or induced abortion of up to 12 weeks gestation provided the following crite...

Hyqvia (immune Globulin 10 Percent- Human With Recombinant Human Hyaluronidase Kit

HYQVIA is an immune globulin with a Recombinant Human Hyaluronidase indicated for the treatment of Primary Immunodeficiency (PI) in adults. This includes, but is not limited to, common variable immun...

I

Icatibant Injection, Solution

Icatibant Injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older....

Iclusig- Ponatinib Hydrochloride Tablet, Film Coated

Iclusig (ponatinib) is a kinase inhibitor indicated for the: Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Ph+ ALL for whom no ot...

Idhifa- Enasidenib Mesylate Tablet, Film Coated

1.1 Acute Myeloid Leukemia IDHIFA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detect...

Ilumya- Tildrakizumab-asmn Injection, Solution

ILUMYA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy....

Imatinib Mesylate- Imatinib Tablet, Film Coated

1.1 Newly Diagnosed Philadelphia Positive Chronic Myeloid Leukemia (Ph+ CML) Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in ch...

Imfinzi- Durvalumab Injection, Solution

1.1 Urothelial Carcinoma IMFINZI is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: have disease progression during or following platinum-co...

Imipenem And Cilastatin Injection, Powder, For Solution

1.1 Lower Respiratory Tract Infections Imipenem and Cilastatin for Injection (I.V.) for intravenous use is indicated for the treatment of lower respiratory tract infections caused by susceptible strai...

Imipenem And Cilastatin- Imipenem And Cilastatin Sodium Injection, Powder, For Solution

1.1 Lower Respiratory Tract Infections Imipenem and Cilastatin for Injection, USP (I.V.) for intravenous use is indicated for the treatment of lower respiratory tract infections caused by susceptible...

Imipenem And Cilastatin- Imipenem And Cilastatin Sodium Injection, Powder, For Solutionimipenem And Cilastatin- Imipenem And Cilastatin Sodium Injection, Powder, For Solution

1.1 Lower Respiratory Tract Infections Imipenem and Cilastatin for Injection, USP (I.V.) for intravenous use is indicated for the treatment of lower respiratory tract infections caused by susceptible...

Imiquimod Cream

1.1 Actinic Keratosis Imiquimod Cream is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults....

Imovax Rabies (rabies Virus Strain Pm-1503-3m Antigen- Propiolactone Inactivated And Water Kit

Imovax Rabies is a vaccine indicated for pre-exposure and post-exposure prophylaxis against rabies. Imovax Rabies vaccine is approved for use in all age groups. 1. Rationale of treatment Physicians ...

Impavido- Miltefosine Capsule

IMPAVIDO (miltefosine) capsules are indicated in adults and adolescents 12 years of age weighing 30 kg for the treatment of: Visceral leishmaniasis caused by Leishmania donovani [see Clini...

Imraldi- Adalimumab Injection, Solution

1.1 Rheumatoid Arthritis IMRALDI is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in ad...

In-111 Dtpa Solution

In-111 DTPA is indicated for use in radionuclide cisternography...

Inapsine- Droperidol Injection

INAPSINE (droperidol) is indicated to reduce the incidence of nausea and vomiting associated with surgical and diagnostic procedures....

Indocyanine Green Kitindocyanine Green Injection, Powder, Lyophilized, For Solution

For determining cardiac output, hepatic function and liver blood flow, and for ophthalmic angiography....

Infanrix- Diphtheria And Tetanus Toxoids And Acellular Pertussis Vaccine Adsorbed Suspension

INFANRIX is indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children 6 weeks to 7 years of age (prior to seventh birthday)....

Infed- Iron Dextran Injection

Intravenous or intramuscular injections of INFeD are indicated for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible....

Infed- Iron Dextran Injection, Solution

Intravenous or intramuscular injections of INFeD are indicated for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible....

Inflectra- Infliximab-dyyb Injection, Powder, Lyophilized, For Solution

1.1 Crohn's Disease INFLECTRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have...

Infuvite Adult Multiple Vitamins- Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 Phosphate Sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol Acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin Injection, Solution

INFUVITE ADULT is a combination of vitamins indicated for the prevention of vitamin deficiency in adults and children aged 11 and older receiving parenteral nutrition. The physician should not await t...

Ingrezza- Valbenazine Capsuleingrezza- Valbenazine Kit

INGREZZA is indicated for the treatment of adults with tardive dyskinesia [see Clinical Studies (14)]....

Injectafer- Ferric Carboxymaltose Injection Injection, Solution

Injectafer is indicated for the treatment of iron deficiency anemia in adult patients: who have intolerance to oral iron or have had unsatisfactory response to oral iron; who have non-dialysis depen...

Inlyta- Axitinib Tablet, Film Coated

INLYTA is indicated for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy....

Innohep- Tinzaparin Sodium Injection

INNOHEP is indicated for the treatment of acute symptomatic deep vein thrombosis with or without pulmonary embolism when administered in conjunction with warfarin sodium. The safety and effectivene...

Insects Whole Body, Fire Ant Mix Injection, Solutionmolds - Alternaria/hormodendrum Mix Injection, Solutionmolds - Mold Mix 10 Injection, Solutionmolds - Mold Mix 4 Injection, Solutionmolds - Trichophyton Mix Injection, Solutionmolds, Penicillium Mix Injection, Solutionmolds, Rusts And Smuts, Alternaria Tenuis- Alternaria Tenuis Injection, Solutionmolds, Rusts And Smuts, Aspergillus Fumigatus- Aspergillus Fumigatus Injection, Solutionmolds, Rusts And Smuts, Aspergillus Niger- Aspergillus Niger Injection, Solutionmolds, Rusts And Smuts, Botrytis Cinerea- Botrytis Cinerea Injection, Solutionmolds, Rusts And Smuts, Candida Albicans- Candida Albicans Injection, Solutionmolds, Rusts And Smuts, Cephalosporium Acremonium- Cephalosporium Acremonium Injection, Solutionmolds, Rusts And Smuts, Curvularia Spicifera- Curvularia Spicifera Injection, Solutionmolds, Rusts And Smuts, Epicoccum Nigrum- Epicoccum Nigrum Injection, Solution

20,21,22,23Allergenic extracts are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific environmental allergens. The sele...

Insulin Aspart Injection, Solution

Insulin aspart is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus....

Insulin Aspart Protamine And Insulin Aspart- Insulin Aspart Injection, Suspension.insulin Aspart Protamine And Insulin Aspart- Insulin Aspart Injection, Suspension

Insulin aspart protamine and insulin aspart is a mixture of insulin aspart protamine and insulin aspart indicated to improve glycemic control in patients with diabetes mellitus. Limitations of Use: ...

Insulin Lispro Injection, Solutioninsulin Lispro Kwikpen- Insulin Lispro Injection, Solution

Insulin lispro is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus....

Intermezzo- Zolpidem Tartrate Tablet

INTERMEZZO (zolpidem tartrate) sublingual tablet is indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Limit...

Intralipid Emulsion

Intralipid 20% is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time (usually for more than 5 days) and as a source ...

Intralipid- I.v. Fat Emulsion Emulsion

Intralipid 20% Pharmacy Bulk Package is indicated for use in a pharmacy admixture program for the preparation of three-in-one or total nutrition admixtures (TNAs) to provide a source o...

Intron A- Interferon Alfa-2b Kitintron A- Interferon Alfa-2b Injection, Solution

Hairy Cell Leukemia INTRON A is indicated for the treatment of patients 18 years of age or older with hairy cell leukemia. Malignant Melanoma INTRON A is indicated as adjuvant to surgical treatme...

Invanz- Ertapenem Sodium Injection, Powder, Lyophilized, For Solution

To reduce the development of drug-resistant bacteria and maintain the effectiveness of INVANZ and other antibacterial drugs, INVANZ should be used only to treat or prevent infections that are proven...

Inversine- Inversine Tablet

For the management of moderately severe to severe essential hypertension and in uncomplicated cases of malignant hypertension....

Invirase- Saquinavir Mesylate Capsuleinvirase- Saquinavir Mesylate Tablet, Film Coated

INVIRASE in combination with ritonavir and other antiretroviral agents is indicated for the treatment of HIV-1 infection in adults (over the age of 16 years). The following points should be considere...

Invirase- Saquinavir Mesylate Tablet, Film Coated

INVIRASE in combination with ritonavir and other antiretroviral agents is indicated for the treatment of HIV infection. The twice daily administration of INVIRASE in combination with ritonavir is supp...

Invokamet- Canagliflozin And Metformin Hydrochloride Tablet, Film Coatedinvokamet Xr- Canagliflozin And Metformin Hydrochloride Tablet, Film Coated, Extended Release

INVOKAMET and INVOKAMET XR are a combination of canagliflozin and metformin hydrochloride (HCl) indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes ...

Invokana- Canagliflozin Tablet, Film Coated

INVOKANA (canagliflozin) is indicated: as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. to reduce the risk of major adverse cardiovascular eve...

Ipol (poliovirus Type 1 Antigen (formaldehyde Inactivated), Poliovirus Type 2 Antigen (formaldehyde Inactivated), And Poliovirus Type 3 Antigen- Formaldehyde Inactivated Injection, Suspension

IPOL vaccine is indicated for active immunization of infants (as young as 6 weeks of age), children, and adults for the prevention of poliomyelitis caused by poliovirus Types 1, 2, and 3. (28) IN...

Isentress Tablet, Film Coated

ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in patients 4 weeks of age and older. The use of other acti...

Isentress- Raltegravir Tablet, Film Coated

Adult Patients: ISENTRESS and ISENTRESS HD are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult pa...

Isentress- Raltegravir Tablet, Film Coatedisentress- Raltegravir Tablet, Chewableisentress- Raltegravir Granule, For Suspension

Adult Patients: ISENTRESS and ISENTRESS HD are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients. P...

Ismo- Isosorbide Mononitrate Tablet, Film Coated

The recommended regimen of Ismo tablets is 20 mg (one tablet) twice daily, with the two doses given 7 hours apart. For most patients, this can be accomplished by taking the first dose on awaken...

Isonarif- Rifampin And Isoniazid Capsule

For pulmonary tuberculosis in which organisms are susceptible, and when the patient has been titrated on theindividual components and it has therefore been established that this fixed dosage is therap...

Isopto Carpine- Pilocarpine Hydrochloride Solution/ Drops

Isopto Carpine is indicated for the: 1.1 Reduction of Elevated Intraocular Pressuare (IOP) in Patients with Open-Angle Glaucoma or Ocular Hypertension 1.2 Management of Acute Angle-Closure Gla...

Isopto Cetamide- Sulfacetamide Sodium Solution

For the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms and as an adjunctive in systemic sulfonamide therapy of trachoma: Escherichia coli, Staphy...

Isopto Cetamide- Sulfacetamide Sodium Solution/ Dropscetamide- Sulfacetamide Sodium Ointment

Solution For the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms and as an adjunctive in systemic sulfonamide therapy of trachoma: Escherichia co...

Isorbide Dinitrate- Isorbide Dinitrate Tablet, Extended Release

Isosorbide Dinitrate Extended-release Tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of controlled-release oral isosorbide dinitrate is...

Isordil Titradose- Isosorbide Dinitrate Tablet

Isordil (isosorbide dinitrate) Titradose tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate ...

Isosorbide Dinitrate Tablet

Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently ...

Isosorbide Dinitrate Tabletisosorbide Dinitrate Tablet

Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently ...

Isosorbide Dinitrate- Isosorbide Dinitrate Tablet

Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently ...

Isosorbide- Isosorbide Dinitrate Tablet

Isosorbide Dinitrate Tablets, USP are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficie...

Isosorbide- Isosorbide Mononitrate Tablet, Film Coated, Extended Release

Isosorbide Mononitrate Extended-Release Tablets, USP are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not suff...

Istodax- Romidepsin Kit

1.1 Cutaneous T-Cell Lymphoma ISTODAX is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy. 1.2 Peripheral T-C...

Itraconazole Capsule

Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: 1. Blastomycosis, pulmonar...

Itraconazole- Itraconazole Capsules Capsule

Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: Blastomycosis, pulmonary and extrapulmonary Histoplas...

Ivermectin Cream

Ivermectin cream is indicated for the treatment of inflammatory lesions of rosacea....

Ivermectin Tablet

Ivermectin is indicated for the treatment of the following infections: Strongyloidiasis of the intestinal tract Ivermectin is indicated for the treatment of intestinal (i.e., nondisseminated) strong...

Ixiaro- Japanese Encephalitis Vaccine, Inactivated, Adsorbed Injection, Suspension

IXIARO is a vaccine indicated for the prevention of disease caused by Japanese encephalitis virus (JEV). IXIARO is approved for use in individuals 2 months of age and older....

Ixinity (coagulation Factor Ix- Recombinant Kit

IXINITY, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children 12 years of age with hemophilia B for: Control and prevention of bleeding episod...

J

Jadenu- Deferasirox Tablet, Film Coatedjadenu- Deferasirox Granule

1.1 Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload) JADENU is indicated for the treatment of chronic iron overload due to blood transfusions (transf...

Jantoven- Warfarin Sodium Tablet

JANTOVEN is indicated for: Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE). Prophylaxis and treatment of thromboembolic complications associated with atr...

Janumet Xr- Sitagliptin And Metformin Hydrochloride Tablet, Film Coated, Extended Release

JANUMET XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use JANUMET XR should not be used in patients ...

Janumet- Sitagliptin And Metformin Hydrochloride Tablet, Film Coated

JANUMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use JANUMET should not be used in patients with type 1 diabe...

Januvia- Sitagliptin Tablet, Film Coated

1.1 Monotherapy and Combination Therapy JANUVIA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. [See Clinical Studies (14).] 1...

Jardiance- Empagliflozin Tablet, Film Coated

JARDIANCE is indicated: as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, to reduce the risk of cardiovascular...

Jentadueto Xr- Linagliptin And Metformin Hydrochloride Tablet, Film Coated, Extended Release

JENTADUETO XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Dosage and Administration (2.1) and Clinical Studies (14.1)]. L...

Jentadueto- Linagliptin And Metformin Hydrochloride Tablet, Film Coated

1.1 Indication JENTADUETO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appr...

Jentadueto- Linagliptin Tablet, Film Coated

1.1 Indication JENTADUETO tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformi...

Jetrea- Ocriplasmin Injection, Solution

JETREA is a proteolytic enzyme indicated for the treatment of symptomatic vitreomacular adhesion....

Jeuveau- Prabotulinum Toxin Type A Powder

JEUVEAU is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients....

Juluca- Dolutegravir Sodium And Rilpivirine Hydrochloride Tablet, Film Coated

JULUCA is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologica...

Juxtapid- Lomitapide Mesylate Capsule

1.1 Homozygous Familial Hypercholesterolemia JUXTAPID is indicated as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density l...

Jynarque- Tolvaptan Kitjynarque- Tolvaptan Tablet

JYNARQUE is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD)....

K

Kabiven- Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine Injection, Emulsion

KABIVEN is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not pos...

Kalbitor- Ecallantide Injection, Solution

KALBITOR (ecallantide) is indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older....

Kaletra- Lopinavir And Ritonavir Tablet, Film Coated

KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. The following points should be considered when initiating therapy with KALETRA: The use of o...

Kaletra- Lopinavir And Ritonavir Tablet, Film Coatedkaletra- Lopinavir And Ritonavir Solution

KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: Genotypic or phenotypi...

Kalydeco- Ivacaftor Tablet, Film Coatedkalydeco- Ivacaftor Granule

KALYDECO is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients age 6 months and older who have one mutation in the...

Kanjinti- Trastuzumab-anns Injection, Powder, Lyophilized, For Solution

1.1 Adjuvant Breast Cancer KANJINTI is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical...

Kanuma- Sebelipase Alfa Injection, Solution, Concentrate

KANUMA is indicated for the treatment of patients with a diagnosis of Lysosomal Acid Lipase (LAL) deficiency....

Kazano- Alogliptin And Metformin Hydrochloride Tablet, Film Coated

1.1 Monotherapy and Combination Therapy KAZANO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both alogliptin a...

Kcentra- Prothrombin, Coagulation Factor Vii Human, Coagulation Factor Ix Human, Coagulation Factor X Human, Protein C, Protein S Human, And Water Kit

Kcentra, (Prothrombin Complex Concentrate (Human)), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K a...

Kepivance- Palifermin Injection, Powder, Lyophilized, For Solution

1.1 Indications Kepivance is a mucocutaneous epithelial human growth factor indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies rec...

Kerydin- Tavaborole Solution

KERYDIN (tavaborole) topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes....

Ketaconazole Aerosol, Foam

Ketoconazole foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Limitations of Use Safety and efficacy of ketoconazole foa...

Ketoconazole Aerosol, Foam

Ketoconazole Foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Limitations of Use Safety and efficacy of Ketoconazole Foa...

Ketoconazole Cream

Ketoconazole Cream 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treat...

Ketorocaine L Kit- Ketorolac Tromethamine, Lidocaine Hydrochloride, Povidine Iodine Kit

Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anes...

Kevzara- Sarilumab Injection, Solution

KEVZARA is indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying ...

Keytruda- Pembrolizumab Injection, Powder, Lyophilized, For Solutionkeytruda- Pembrolizumab Injection, Solution

1.1 Melanoma KEYTRUDA (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic melanoma. KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma ...

Khapzory- Levoleucovorin Injection, Powder, Lyophilized, For Solution

KHAPZORY is indicated for: rescue after high-dose methotrexate therapy in patients with osteosarcoma. diminishing the toxicity associated with overdosage of folic acid antagonists or impaired ...

Kineret- Anakinra Injection, Solution

1.1 Active Rheumatoid Arthritis Kineret is indicated for the reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis (RA...

Kinevac- Sincalide Injection, Powder, Lyophilized, For Solution

Kinevac is indicated in adults to: to stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile...

Kinlytic- Urokinase Injection, Powder, Lyophilized, For Solution

Kinlytic is indicated in adults: For the lysis of acute massive pulmonary emboli, defined as obstruction of blood flow to a lobe or multiple segments. For the lysis of pulmonary emboli accompanied...

Kinrix- Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus Vaccine Injection, Suspension

A single dose of KINRIX is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vacc...

Koate (antihemophilic Factor- Human Kit

KO TE is a human plasma-derived antihemophilic factor indicated for the control and prevention of bleeding episodes or in order to perform emergency and elective surgery in patients with hemophilia...

Kogenate Fs (antihemophilic Factor- Recombinant Kit

Kogenate FS is a recombinant antihemophilic factor indicated for: On-demand treatment and control of bleeding episodes in adults and children with hemophilia A. Perioperative management of...

Korlym- Mifepristone Tablet

KORLYM (mifepristone) is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mell...

Kovaltry (antihemophilic Factor- Recombinant Kit

KOVALTRY, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital ...

Krystexxa- Pegloticase Injection, Solution

KRYSTEXXA (pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. Gout refractory to conventional the...

Kuvan- Sapropterin Dihydrochloride Tabletkuvan- Sapropterin Dihydrochloride Powder, For Solutionkuvan- Sapropterin Dihydrochloride Powder, For Solution

Kuvan (sapropterin dihydrochloride) is indicated to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria...

Kybella- Deoxycholic Acid Injection, Solution

1.1 Fullness Associated with Submental Fat KYBELLA (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated ...

Kyprolis- Carfilzomib Injection, Powder, Lyophilized, For Solution

1.1 Relapsed or Refractory Multiple Myeloma Kyprolis is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed o...

L

L-methyl-mc-nac- Levomefolate Calcium, Methylcobalamin, And Acetylcysteine Tablet, Coated

L-Methyl-MC-NAC Tablets is indicated for the distinct nutritional requirements of individuals under a physician's treatment for early memory loss 25 with particular emphasis for those individuals diag...

Lacrisert- Hydroxypropyl Cellulose Pellet

LACRISERT is indicated in patients with moderate to severe dry eye syndromes, including keratoconjunctivitis sicca. LACRISERT is indicated especially in patients who remain symptomatic after an adequa...

Lantus- Insulin Glargin Injection, Solutionlantus- Insulin Glargine Injection, Solution

LANTUS is indicated to improve glycemic control in adults and children with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Important Limitations of Use: LANTUS is not recommen...

Lantus- Insulin Glargine Injection, Solutionlantus Solostar- Insulin Glargine Injection, Solution

LANTUS is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Limitations of Use LANTUS is not recommend...

Laviv- Azficel-t Injection, Suspension

LAVIVTM is an autologous cellular product indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults. The safety and efficacy of LAVIV for areas other...

Ledipasvir And Sofosbuvir Tablet, Film Coated

Ledipasvir and sofosbuvir is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) [see Dosage and Administration (2.2 and 2.3) and...

Leep Redikit- Mepivacaine Hydrochloride, Lidocaine Hydrochloride, Epinephrine Bitartrate, Iodine, Potassium Iodide, Ferric Subsulfate Kit

Xylocaine (lidocaine HCl) Injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by perip...

Lemtrada- Alemtuzumab Injection, Solution, Concentrate

LEMTRADA is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of LEMTRADA should generally be reserved for patients who ha...

Lenvima- Lenvatinib Capsulelenvima- Lenvatinib Kit

1.1 Differentiated Thyroid Cancer LENVIMA is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated th...

Letairis- Ambrisentan Tablet, Film Coated

Letairis is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): To improve exercise ability and delay clinical worsening. In combination with tadalafil to reduce the ...

Leucovorin Calcium Injection

Leucovorin calcium rescue is indicated after high dose methotrexate therapy in osteosarcoma. Leucovorin calcium is also indicated to diminish the toxicity and counteract the effects of impaired methot...

Leucovorin Calcium Injection, Powder, Lyophilized, For Solution

Leucovorin calcium rescue is indicated after high dose methotrexate therapy in osteosarcoma. Leucovorin calcium is also indicated to diminish the toxicity and counteract the effects of impaired methot...

Leucovorin- Leucovorin Calcium Injection, Powder, For Solution

Leucovorin calcium rescue is indicated after high dose methotrexate therapy in osteosarcoma. Leucovorin calcium is also indicated to diminish the toxicity and counteract the effects of impaired methot...

Leukine- Sargramostim Injection, Powder, Lyophilized, For Solutionleukine- Sargramostim Injection, Solution

1.1 Acute Myeloid Leukemia Following Induction Chemotherapy LEUKINE is indicated to shorten time to neutrophil recovery and to reduce the incidence of severe, life-threatening, or fatal infections fol...

Leukine- Sargramostim Liquidleukine- Sargramostim Injection, Powder, For Solution

1.1 Acute Myeloid Leukemia Following Induction Chemotherapy LEUKINE is indicated to shorten time to neutrophil recovery and to reduce the incidence of severe, life-threatening, or fatal infections fo...

Leuprolide Acetate Injection, Solution

LEUPROLIDE ACETATE INJECTION is indicated in the palliative treatment of advanced prostatic cancer....

Leuprolide Acetate Kit

Leuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer....

Levo-t- Levothyroxine Sodium Tablet

Hypothyroidism LEVO-T is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (...

Levocarnitine Injection, Solution

For the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency....

Levocarnitine Solution

Levocarnitine Oral Solution USP is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like e...

Levocarnitine Tablet

Levocarnitine is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, hypo...

Levocarnitine- Levocarnitine Oral Solution Solutionlevocarnitine (levocarnitine Oral Solution- Suguar Free 1 G/10 Ml Solution

Levocarnitine is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, hypo...

Levothroid- Levothyroxine Sodium Tablet

Levothyroxine sodium is used for the following indications: Hypothyroidism As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyro...

Levothyroxine And Liothyronine Thyroid- Levothyroxine And Liothyronine Tablet

Levothyroxine and Liothyronine tablets (thyroid tablets, USP) are indicated: 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism ...

Levothyroxine Sodium Injection, Powder, Lyophilized, For Solution

Levothyroxine Sodium for Injection is indicated for the treatment of myxedema coma. Important Limitations of Use: The relative bioavailability between Levothyroxine Sodium for Injection and oral levot...

Levothyroxine Sodium Injection, Solution

Levothyroxine Sodium Injection is indicated for the treatment of myxedema coma. Limitations of Use: Not recommended as a substitute for oral levothyroxine sodium because the relative bioavailabilit...

Levothyroxine Sodium Tablet

Levothyroxine sodium is used for the following indications: Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyro...

Levothyroxine Sodium Tabletlevothyroxine Sodium Tablet

Hypothyroidism Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. P...

Levothyroxine Sodium- Levothyroxine Sodium Anhydrous Injection, Powder, Lyophilized, For Solution

Levothyroxine Sodium for Injection is indicated for the treatment of myxedema coma. Important Limitations of Use: The relative bioavailability between Levothyroxine Sodium for Injection and oral levot...

Levothyroxine Sodium- Llevothyroxine Sodium Tabletlevothyroxine Sodium Tablet

Levothyroxine sodium is used for the following indications: Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyro...

Levulan Kerastick- Aminolevulinic Acid Hydrochloride

The LEVULAN KERASTICK for Topical Solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick acti...

Levulan Kerastick- Aminolevulinic Acid Hydrochloride Kit

The LEVULAN KERASTICK for topical solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick acti...

Lexiva- Fosamprenavir Calcium Tablet, Film Coated

LEXIVA is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. The following points should be considered when initiating t...

Lexiva- Fosamprenavir Calcium Tablet, Film Coatedlexiva- Fosamprenavir Calcium Suspension

LEXIVA is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. The following points should be considered when initiating ther...

Librax- Chlordiazepoxide Hydrochloride And Clidinium Bromide Capsule

Librax is indicated to control emotional and somatic factors in gastrointestinal disorders. Librax may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the ...

Linezolid Injection, Solution

Linezolid injection is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezolid injection is not indi...

Linezolid Powder, For Suspension

Linezolid for Oral Suspension is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezolid for Oral Su...

Linezolid Suspension

Linezolid is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezolid is not indicated for the treatm...

Linezolid Tablet

Linezolid tablets are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezolid tablets are not indica...

Linezolid Tablet, Film Coated

Linezolid is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezolid is not indicated for the treat...

Linezolid- Linezolid Tablet, Film Coated

Linezolidis indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezolid is not indicated for the treatme...

Linzess- Linaclotide Capsule, Gelatin Coated

LINZESS is indicated in adults for the treatment of: irritable bowel syndrome with constipation (IBS-C) chronic idiopathic constipation (CIC)....

Liothyronine Sodium Injection, Solution

Liothyronine sodium injection (T3) is indicated in the treatment of myxedema coma/precoma. Liothyronine sodium injection (T3) can be used in patients allergic to desiccated thyroid or thyroid extract ...

Liothyronine Sodium Tablet

1.1 Hypothyroidism Liothyronine sodium is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. 1.2 Pi...

Lithostat- Acetohydroxamic Acid Tablet

Acetohydroxamic acid is indicated as adjunctive therapy in patients with chronic urea-splitting urinary infection. AHA is intended to decrease urinary ammonia and alkalinity, but it should not be used...

Lonsurf- Trifluridine And Tipiracil Tablet, Film Coated

1.1 Metastatic Colorectal Cancer LONSURF is indicated for the treatment of adult patients with metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based...

Lopinavir-ritonavir Solution

Lopinavir and ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: Geno...

Lovaza- Omega-3-acid Ethyl Esters Capsule, Liquid Filled

LOVAZA (omega-3-acid ethyl esters) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe ( 500 mg/dL) hypertriglyceridemia (HTG). ...

Lucentis- Ranibizumab Injection, Solution

LUCENTIS is indicated for the treatment of patients with: 1.1 Neovascular (Wet) Age-Related Macular Degeneration (AMD) 1.2 Macular Edema Following Retinal Vein Occlusion (RVO) 1.3 Diabet...

Lumizyme- Alglucosidase Alfa Injection, Powder, For Solution

LUMIZYME (alglucosidase alfa) [see Description (11)] is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with Pompe disease (acid -glucosidase [GAA] deficiency)....

Lupaneta Pack- Leuprolide Acetate And Norethindrone Acetate Kit

LUPANETA PACK (leuprolide acetate for depot suspension and norethindrone acetate tablets) is indicated for initial management of the painful symptoms of endometriosis and for management of recurrence ...

Lupron Depot- Leuprolide Acetate Kit

1.1 Endometriosis LUPRON DEPOT 11.25 mg for 3-month administration is indicated for management of endometriosis, including pain relief and reduction of endometriotic lesions. Laparoscopic staging of ...

Lupron Depot-ped- Leuprolide Acetate Kit

LUPRON DEPOT-PED is indicated in the treatment of children with central precocious puberty (CPP). CPP is defined as early onset of secondary sexual characteristics (generally earlier than 8 years of a...

Lupron- Leuprolide Acetatelupron- Leuprolide Acetate Injection, Solution

LUPRON INJECTION is indicated in the treatment of children with central precocious puberty. Children should be selected using the following criteria: Clinical diagnosis of CPP (idiopathic or neuroge...

Lynparza- Olaparib Capsule

1.1 Advanced gBRCA-mutated Ovarian Cancer after 3 or More Lines of Chemotherapy Lynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutate...

Lynparza- Olaparib Tablet, Film Coated

1.1 First-Line Maintenance Treatment of BRCA-mutated Advanced Ovarian Cancer Lynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or...

Lysteda- Tranexamic Acid Tablet

LYSTEDA (tranexamic acid, USP) Tablets is indicated for the treatment of cyclic heavy menstrual bleeding [see Clinical Studies (14)]. Prior to prescribing LYSTEDA, exclude endometrial pathology tha...

M

M-m-r Ii- Measles, Mumps, And Rubella Virus Vaccine Live Injection, Powder, Lyophilized, For Suspension

Recommended Vaccination Schedule M-M-R II is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals 12 months of age or older. Individuals first vaccinated at 12 ...

M.v.i. Adult- Retinol, Ergocalciferol, .alpha.-tocopherol Acetate, Dl-, Phytonadione, Ascorbic Acid, Niacinamide, Riboflavin 5-phosphate Sodium, Thiamine Hydrochloride, Pyridoxine Hydrochloride, Dexpanthenol, Biotin, Folic Acid, And Cyanocobalamin Kit

M.V.I. Adult is a combination of vitamins indicated for the prevention of vitamin deficiency in adults and pediatric patients aged 11 and older receiving parenteral nutrition. The physician should ...

M.v.i. Pediatric- Ascorbic Acid, Retinol, Ergocalciferol, Thiamine Hydrochloride, Riboflavin 5-phosphate Sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, .alpha.-tocopherol Acetate, Dl-, Biotin, Folic Acid, Cyanocobalamin, And Phytonadione Injection, Powder, Lyophilized, For Solution

M.V.I. Pediatric is a combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition. The physician should not aw...

Maci- Autologous Cultured Chondrocytes Implant

MACI (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of single or multiple symptomatic, full-thickness cartila...

Macrilen- Macimorelin Acetate Granule, For Solution

MACRILEN is indicated for the diagnosis of adult growth hormone deficiency (AGHD). Limitations of Use The safety and diagnostic performance of MACRILEN have not been established for subjects with a...

Macrobid- Nitrofurantoin Monohydrate And Nitrofurantoin, Macrocrystalline Capsule

Macrobid is indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofu...

Macrobid- Nitrofurantoin Monohydrate/macrocrystalline Capsule

Macrobid is indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofu...

Macrodantin- Nitrofurantoin Macrocrystals Capsule

Macrodantin is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible str...

Macrodantin- Nitrofurantoin, Macrocrystalline Capsule

Macrodantin is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible str...

Mafenide Acetate Powder, For Solution

Mafenide Acetate,USP For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on ...

Manganese Sulfate Injection, Solution

Manganese Sulfate Injection, USP is indicated for use as a supplement to intravenous solutions given for Total Parenteral Nutrition (TPN). Administration helps to maintain plasma levels and to prevent...

Manganese- Manganese Chloride Injection, Solution

Manganese 0.1 mg/mL (Manganese Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain mangan...

Marinol- Dronabinol Capsule

MARINOL is indicated in adults for the treatment of: anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS). nausea and vomiting associated with cancer chemo...

Marplan- Isocarboxazid Tablet

Marplan is indicated for the treatment of depression. Because of its potentially serious side effects, Marplan is not an antidepressant of first choice in the treatment of newly diagnosed depressed pa...

Marqibo- Vincristine Sulfate Kit

1.1 Adult ALL in Second or Greater Relapse Marqibo is indicated for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greate...

Mavyret- Glecaprevir And Pibrentasvir Tablet, Film Coated

MAVYRET is indicated for the treatment of adult and pediatric patients 12 years and older or weighing at least 45 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without...

Maxzide-25- Maxzide Tabletmaxzide Tablet

This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. MAXZIDE (triamterene ...

Mebendazole Tablet, Chewable

Mebendazole tablets are indicated for the treatment of Enterobius vermicularis (pinworm), Trichuris trichiura (whipworm), Ascaris lumbricoides (common roundworm), Ancylostoma duodenale (common hookwor...

Mecamylamine Hydrochloride Tablet

For the management of moderately severe to severe essential hypertension and in uncomplicated cases of malignant hypertension....

Membraneblue- Trypan Blue Injection, Solution

HIGHLIGHTS OF PRESCRIBING INFORMATION (1) These highlights do not include all the information needed to use MembraneBlue 0.15% safely and effectively. See full prescribing information for Membrane...

Menactra- Neisseria Meningitidis Group A Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen, Neisseria Meningitidis Group C Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen, Neisseria Meningitidis Group Y Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen, And Neisseria Meningitidis Group W-135 Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen Injection, Solution

Menactra , Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine, is indicated for active immunization to prevent invasive meningococcal disease caused by Neisse...

Mentax- Butenafine Hydrochloride Cream

Mentax (butenafine HCl) Cream, 1% is indicated for the topical treatment of the dermatologic infection, tinea (pityriasis) versicolor due to M. furfur (formerly P. orbiculare). Butenafine HCl cream ...

Menveo (meningococcal- Groups A, C, Y And W-135 Oligosaccharide Diphtheria Crm197 Conjugate Vaccine Kit

MENVEO is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. MENVEO is approved for use in persons 2 ...

Mephyton- Phytonadione Tablet

MEPHYTON is indicated in the following coagulation disorders which are due to faulty formation of factors II,VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. ...

Mepsevii- Vestronidase Alfa Injection

MEPSEVII is indicated in pediatric and adult patients for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome). Limitations of Use The effect of MEPSEVII on the central nervous syst...

Meropenem And Sodium Chloride Injection, Solution

1.1 Complicated Skin and Skin Structure Infections (Adult Patients and Pediatric Patients 3 Months of age and older requiring the full adult dose only) Meropenem for Injection USP and Sodium Chloride...

Meropenem Injection

1.1 Complicated Skin and Skin Structure Infections (Adult Patients and Pediatric Patients 3 Months of age and older only) Meropenem for injection is indicated for the treatment of complicated skin and...

Meropenem- Meropenem Injection, Powder, For Solution

1.1 Complicated Skin and Skin Structure Infections (Adult Patients and Pediatric Patients 3 Months of Age and Older Only) Meropenem for injection is indicated for the treatment of complicated skin and...

Mesna Injection, Solution

Mesna Injection is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. Limitation of Use:Mesna Injection is not indicated to reduce the risk of hema...

Mesna- Mesna Injection Solution

Mesna Injection is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. Limitation of Use: Mesna Injection is not indicated to reduce the risk of hem...

Methamphetamine Hydrochloride Tablet

Attention Deficit Disorder with Hyperactivity Methamphetamine hydrochloride tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psy...

Methazel Capsule

Methazel is indicated for the distinct nutritional requirements of patients in need of dietary supplementation as determined by a licensed medical practitioner. Methazel should be administered under t...

Methergine- Methylergonovine Maleate Tablet

Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery o...

Methimazole Tablet

Methimazole is indicated: In patients with Graves' disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option. ...

Methimazole- Methimazole Tablet

Methimazole is indicated in the medical treatment of hyperthyroidism. Long-term therapy may lead to remission of the disease. Methimazole may be used to ameliorate hyperthyroidism in preparation for s...

Methotrexate Injection

Neoplastic Diseases Methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. In acute lymphocytic leukemia, methotrexate is indicated i...

Methotrexate Injection, Powder, Lyophilized, For Solution

Neoplastic Diseases Methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. In acute lymphocytic leukemia, methotrexate is indicated i...

Methotrexate Injection, Solution

Neoplastic Diseases Methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. In acute lymphocytic leukemia, methotrexate is indicated i...

Methotrexate Sodium Tablet

Neoplastic DiseasesMethotrexate tablets are indicated in the treatment of gestational choriocarcinoma, chorio-adenoma destruens and hydatidiform mole. Methotrexate is used in maintenance therapy in c...

Methotrexate- Methotrexate Sodium Injection, Powder, Lyophilized, For Solution

Neoplastic Diseases Methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. In acute lymphocytic leukemia, methotrexate is indicated ...

Methotrexate- Methotrexate Sodium Injection, Solution

Neoplastic Diseases Methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. In acute lymphocytic leukemia, methotrexate is indicated f...

Methotrexate- Methotrexate Sodium Tablet

Neoplastic Diseases Methotrexate is indicated in the treatment of gestational choriocarcinoma, chori-oadenoma destruens and hydatidiform mole. Methotrexate is used in maintenance therapy in combinatio...

Methoxsalen Capsule, Liquid Filled

Photochemotherapy (Methoxsalen with long wave UVA radiation) is indicated for the symptomatic control of severe, recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy a...

Methylene Blue Injection

Drug-induced methemoglobinemia....

Metoclopramide Hydrochloride Injection, Solution

Diabetic Gastroparesis (Diabetic Gastric Stasis) Metoclopramide injection USP is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. The Prevention of...

Metoclopramide Hydrochloride Solution

The use of Metoclopramide Oral Solution is recommended for adults only. Therapy should not exceed 12 weeks in duration. Symptomatic Gastroesophageal Reflux Metoclopramide Oral Solution is indicated ...

Metoclopramide Hydrochloride Tablet

The use of metoclopramide tablets is recommended for adults only. Therapy should not exceed 12 weeks in duration. Symptomatic Gastroesophageal Reflux: Metoclopramide tablets are indicated as s...

Metoclopramide- Metoclopramide Hydrochloride Injection

Diabetic Gastroparesis (Diabetic Gastric Stasis) Metoclopramide injection, USP (metoclopramide hydrochloride, USP) is indicated for the relief of symptoms associated with acute and recurrent diabetic ...

Metoclopramide- Metoclopramide Hydrochloride Injection, Solution

Diabetic Gastroparesis (Diabetic Gastric Stasis). Metoclopramide is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. The Prevention of Nausea and Vom...

Metoclopramide- Metoclopramide Hydrochloride Solution

Metoclopramide is indicated for the: Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. Relief of symptoms in adults...

Metoclopramide- Metoclopramide Hydrochloride Tablet

The use of metoclopramide tablets is recommended for adults only. Therapy should not exceed 12 weeks in duration. Symptomatic Gastroesophageal Reflux Metoclopramide tablets are indicated as short-te...

Metoclopramide- Metoclopramide Tablet

The use of metoclopramide tablets, USP is recommended for adults only. Therapy should not exceed 12 weeks in duration. Symptomatic Gastroesophageal Reflux Metoclopramide tablets, USP are indicated...

Metopirone- Metyrapone Capsule, Gelatin Coated

Metopirone is a diagnostic drug for testing hypothalamic-pituitary ACTH function....

Metrocream- Metronidazole Cream

METROCREAM (metronidazole topical cream) Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea....

Metrogel- Metronidazole Gel

METROGEL is indicated for the topical treatment of inflammatory lesions of rosacea....

Metrolotion- Metronidazole Lotion

MetroLotion Topical Lotion is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea....

Metronidazole- Metronidazole Cream

Metronidazole Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea....

Metronidazole- Metronidazole Gel

Metronidazole Gel USP is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea....

Metronidazole- Metronidazole Tablet

Symptomatic Trichomoniasis Metronidazole, USP is indicated for the treatment of symptomatic trichomoniasis in females and males when the presence of the trichomonad has been confirmed by appropriate l...

Metronidazole- Metronidazole Tablet

Symptomatic Trichomoniasis Metronidazole is indicated for the treatment of symptomatic trichomoniasis in females and males when the presence of the trichomonad has been confirmed by appropriate labora...

Metvixia- Methyl Aminolevulinate Hydrochloride Cream

Metvixia Cream in combination with 570 to 670 nm wavelength red light illumination using the CureLight BroadBand Model CureLight 01 lamp is indicated for treatment of non-hyperkeratotic actinic kerato...

Miacalcin- Calcitonin Salmon Injection, Solution

1.1 Treatment of Paget s Disease of Bone Miacalcin injection is indicated for the treatment of symptomatic Paget s disease of bone in patients with moderate to severe disease characterized by pol...

Mifepristone Tablet

Mifepristone tablets, 200mg is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation....

Migergot- Ergotamine Tartrate And Caffeine Suppository

Ergotamine Tartrate and Caffeine Indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called histaminic cephalalgia ....

Miglitol Tablet, Coated

Miglitol tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus....

Miglustat Capsule

1.1 Type 1 Gaucher Disease Miglustat is a glucosylceramide synthase inhibitor indicated as monotherapy for the treatment of adult patients with mild to moderate type 1 Gaucher disease for whom enzyme...

Migranal- Dihydroergotamine Mesylate Spray

MIGRANAL (dihydroergotamine mesylate) Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is not intended...

Miochol E- Acetylcholine Chloride Kit

To obtain miosis of the iris in seconds after delivery of the lens in cataract surgery, in penetrating keratoplasty, iridectomy, and other anterior segment surgery where rapid miosis may be required....

Miostat- Carbachol Solution

Intraocular use for obtaining miosis during surgery. In addition, MIOSTAT* (carbachol intraocular solution, USP) 0.01% reduces the intensity of IOP elevation in the first 24 hours after cataract surge...

Mirapex Er- Pramipexole Dihydrochloride Tablet, Extended Release

MIRAPEX ER tablets are indicated for the treatment of Parkinson's disease....

Mirapex- Pramipexole Dihydrochloride Tablet

1.1 Parkinson's Disease MIRAPEX tablets are indicated for the treatment of Parkinson's disease. 1.2 Restless Legs Syndrome MIRAPEX tablets are indicated for the treatment of moderate-to-severe prim...

Mircera- Methoxy Polyethylene Glycol-epoetin Beta Injection, Solution

1.1 Anemia Due to Chronic Kidney Disease Mircera is indicated for the treatment of anemia associated with chronic kidney disease (CKD) in: adult patients on dialysis and adult patie...

Mitigare- Colchicine Capsule

MITIGARE (colchicine) capsules are indicated for prophylaxis of gout flares in adults. Limitations of use: The safety and effectiveness of MITIGARE for acute treatment of gout flares during prop...

Modafinil Tablet

Modafinil Tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations...

Monoclate-p- Antihemophilic Factor Human Kit

Monoclate-P is indicated for treatment of classical hemophilia (Hemophilia A). Affected individuals frequently require therapy following minor accidents. Surgery, when required in such individuals, ...

Mononine- Coagulation Factor Ix Human Kit

MONONINE is indicated for the prevention and control of bleeding in Factor IX deficiency, also known as Hemophilia B or Christmas disease. Limitation of Use MONONINE is not indicated in the treatmen...

Montelukast Sodium Chewable- Montelukast Sodium Tablet, Chewable

1.1 Asthma Montelukast sodium chewable tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. 1.2 Exercise-Induced ...

Montelukast Sodium Granule

1.1 Asthma Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in pediatric patients 12 months of age and older. 1.3 Allergic Rhinitis Montelukast sodium is indicat...

Montelukast Sodium Granulemontelukast Sodium Tablet, Chewablemontelukast Sodium- Montelukast Tablet, Chewablemontelukast Sodium Tablet, Coated

1.1 Asthma Montelukast sodium tablets, chewable tablets and oral granules are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older....

Montelukast Sodium Oral Granule

1.1 Asthma Montelukast sodium oral granules are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. 1.2 Allergic Rhinitis Mont...

Montelukast Sodium Tablet

1.1 Asthma Montelukast Sodium Tablets and Chewable Tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. 1.2 Exercise-...

Montelukast Sodium Tablet, Chewablemontelukast Sodium Tablet, Coated

1.1 Asthma Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. 1.2 Exercise-Induced Bronchoconstriction ...

Montelukast Sodium Tablet, Chewablemontelukast Sodium Tabletmontelukast Sodium Granule

1.1 Asthma Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. 1.2 Exercise-Induced Bro...

Montelukast Sodium Tablet, Chewablemontelukast Sodium- Montelukast Tablet, Chewable

1.1 Asthma Montelukast sodium tablets, chewable tablets and oral granules are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older....

Montelukast Sodium Tabletmontelukast Sodium Tablet, Chewable

1.1 Asthma Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. 1.2 Exercise-Induced Bronchoconstriction (E...

Montelukast Sodium- Montelukast Sodium Tablet, Film Coated

1.1 Asthma Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. 1.2 Exercise-Induced Bronchoconstriction (E...

Montelukast Sodium- Montelukast Tablet

1.1 Asthma Montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and adolescents 15 years of age and older. 1.2 Exercise-Induced Bronchoconstrictio...

Montelukast Sodium- Montelukast Tablet, Chewable

1.1 Asthma Montelukast sodium tablets, chewable tablets and oral granules are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older....

Mosquito- Aedes Taeniorhynchus Solutiongerman Cockroach- Blattella Germanica Solutionhouse Fly- Musca Domestica Solutionblack Carpenter Ant- Camponotus Pennsylvanicus Solutionfire Ant- Solenopsis Invicta Solutionfire Ant- Solenopsis Richteri Solutionamerican Cockroach- Periplaneta Americana Solutionflea- Ctenocephalides Felis Solution2 Cockroach Mix- Periplaneta Americana And Blattella Germanica Solution

Allergenic Extracts are indicated for the diagnosis and treatment of patients with immediate hypersensitivity allergy to the respective allergens, inhaled, ingested or otherwise introduced into contac...

Mozobil- Plerixafor Solution

Mozobil is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous tran...

Multihance- Gadobenate Dimeglumine Injection, Solution

1.1 Magnetic Resonance Imaging (MRI) of the Central Nervous System (CNS) MultiHance is indicated for intravenous use in magnetic resonance imaging (MRI) of the central nervous system (CNS) in adu...

Multitrace -4 Pediatric- Trace Elements 4 Injection, Solution, Concentrate

This formulation is indicated for use as a supplement to intravenous solutions given for TPN for children up to 11 years of age. Administration of the solution in TPN solutions helps to maintain plasm...

Multitrace -4- Trace Elements 4 Injection, Solution, Concentrate

This formulation is indicated for use as a supplement to intravenous solutions given for TPN. Administration of the solution in TPN solutions helps to maintain plasma levels of zinc, copper, manganese...

Multitrace-4 Neonatal- Trace Elements 4 Injection, Solution

MULTITRACE - 4 NEONATAL is indicated for use as a supplement to intravenous solutions given for TPN. Administration of MULTITRACE - 4 NEONATAL in TPN solutions helps to maintain plasma levels of z...

Multitrace-4- Trace Elements 4 Injection, Solution

This formulation is indicated for use as a supplement to intravenous solutions given for TPN. Administration of the solution in TPN solutions helps to maintain plasma levels of zinc, copper, manganese...

Multitrace-5- Trace Elements 5 Injection, Solution

This formulation is indicated for use as a supplement to intravenous solutions given for TPN. Administration of the solution in TPN solutions helps to maintain plasma levels of zinc, copper, manganese...

Multitrace-5- Trace Elements 5 Injection, Solution, Concentrate

This formulation is indicated for use as a supplement to intravenous solutions given for TPN. Administration of the solution in TPN solutions helps to maintain plasma levels of zinc, copper, manganese...

Mupirocin 2%- Mupirocin Ointment

Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to: S. aureus and S. pyogenes....

Mupirocin Cream

Mupirocin cream is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible isolates of Staphylococcus aureus (S. aureus...

Mupirocin Ointment

Mupirocin ointment is indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes)....

Muse- Alprostadil Suppository

MUSE is indicated for the treatment of erectile dysfunction. Studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with similarly administered pla...

Mvasi- Bevacizumab-awwb Injection, Solution

1.1 Metastatic Colorectal Cancer MVASI, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with metastati...

Myalept- Metreleptin Injection, Powder, Lyophilized, For Solution

1.1 Patients with Generalized Lipodystrophy MYALEPT (metreleptin) for injection is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients wi...

Mycamine- Micafungin Sodium Injection, Powder, Lyophilized, For Solution

MYCAMINE is indicated in adult and pediatric patients 4 months and older for: 1.1 Treatment of Patients with Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses [see Clin...

Mycobutin- Rifabutin Capsule

MYCOBUTIN Capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection....

Mycophenolate Mofetil Capsule

Mycophenolate mofetil capsules are indicated for the prophylaxis of organ rejection, in recipients of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver tran...

Mycophenolate Mofetil Capsulemycophenolate Mofetil Tablet

Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in recipients of allogeneic kidney [see Clinical Studies (14....

Mycophenolate Mofetil Capsulemycophenolate Mofetil Tablet, Film Coated

Mycophenolate mofetil capsules (MMF) are indicated for the prophylaxis of organ rejection, in recipients of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or live...

Mylotarg- Gemtuzumab Ozogamicin Injection, Powder, Lyophilized, For Solution

1.1 Newly-Diagnosed CD33-positive Acute Myeloid Leukemia (AML) MYLOTARG is indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults. 1.2 Relapsed or Refractory ...

Myobloc- Rimabotulinumtoxinb Injection, Solution

1.1 Cervical Dystonia MYOBLOC is indicated for the treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia in adults. 1.2 Chr...

Myrbetriq- Mirabegron Tablet, Film Coated, Extended Release

1.1 Monotherapy MYRBETRIQ is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. 1.2 C...

N

Nabi-hb (hepatitis B Immune Globulin- Human Liquid

Nabi-HB, Hepatitis B Immune Globulin (Human), is indicated for treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to H...

Naglazyme- Galsulfase Solution

NAGLAZYME (galsulfase) is indicated for patients with Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome). NAGLAZYME has been shown to improve walking and stair-climbing capacity....

Nalbuphine Hydrochloride Injection, Solution

Nalbuphine Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Nalbuphine Hydrochloride In...

Nardil- Phenelzine Sulfate Tablet, Film Coated

NARDIL has been found to be effective in depressed patients clinically characterized as "atypical," "nonendogenous," or "neurotic." These patients often have mixed anxiety and depression and phobic or...

Natacyn- Natamycin Suspension/ Drops

NATACYN (natamycin ophthalmic suspension) 5% is indicated for the treatment of fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms including Fusarium solani keratitis. ...

Nateglinide Tablet

Nateglinide Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use:Nateglinide Tablets should not be used in p...

Nateglinide Tablet, Coated

Nateglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Limitations of Use:Nateglinide tablets should not be used in pa...

Nateglinide Tablet, Film Coated

Nateglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: Nateglinide tablets should not be used in ...

Nateglinide- Nateglinide Tablet, Coated

Nateglinide Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus....

Natpara (parathyroid Hormone)- Parathyroid Hormone Injection, Powder, Lyophilized, For Solution

NATPARA is a parathyroid hormone indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Limitations of Use: Because of the potential risk of ost...

Natrecor- Nesiritide Injection, Powder, Lyophilized, For Solution

NATRECOR (nesiritide) is indicated for the treatment of patients with acutely decompensated heart failure who have dyspnea at rest or with minimal activity. In this population, the use of NATRECOR red...

Navelbine- Vinorelbine Tartrate Injection

NAVELBINE is a vinca alkaloid indicated: In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) As a single agent, f...

Netspot- 68ga-dotatate Kit

NETSPOT, after radiolabeling with Ga 68, is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pedia...

Neulasta- Pegfilgrastim Kitneulasta- Pegfilgrastim Injection

1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with no...

Neupogen- Filgrastim Injection, Solution

1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy NEUPOGEN is indicated to decrease the incidence of infection as manifested by febrile neutropenia in patients with...

Neuraceq- Florbetaben F 18 Injection, Solution

Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate -amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for...

Nimbex- Cisatracurium Besylate Injection

NIMBEX is indicated: as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age to provide skeletal muscle relaxation in adu...

Ninlaro- Ixazomib Capsule

NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy....

Nitisinone Capsule

Nitisinone capsules are indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine....

Nitrofurantion Capsule

Nitrofurantoin Capsules, USP (macrocrystals) is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus a...

Nitrofurantion Macrocrystals Capsule

Nitrofurantoin Macrocrystals is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certai...

Nitrofurantion Macrocrystals- Nitrofurantion Macrocrystals Capsule

Nitrofurantoin Macrocrystals is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certai...

Nityr- Nitisinone Tablet

NITYR is indicated for the treatment of patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine....

Nivestym- Filgrastim-aafi Injection, Solution

1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy NIVESTYM is indicated to decrease the incidence of infection as manifested by febrile neutropenia in patients with nonmyeloid mal...

Norditropin- Somatropin Injection, Solution

1.1 Pediatric Patients Norditropin [somatropin (rDNA origin) injection] is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (GH). No...

Northera- Droxidopa Capsule

NORTHERA is indicated for the treatment of orthostatic dizziness, lightheadedness, or the feeling that you are about to black out in adult patients with symptomatic neurogenic orthostatic hypote...

Norvir Tablet, Film Coated

NORVIR is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection....

Norvir- Ritonavir Tablet, Film Coated

NORVIR tablets and oral solution are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. NORVIR oral powder is indicated in combination with other antiretro...

Norvir- Ritonavir Tablet, Film Coatednorvir- Ritonavir Solutionnorvir- Ritonavir Powder

NORVIR tablets and oral solution are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. NORVIR oral powder is indicated in combination with other antiretro...

Novoeight (- Antihemophilic Factor, Recombinant Kit

Novoeight, Antihemophilic Factor (Recombinant), is a human antihemophilic factor (human blood coagulation factor VIII (FVIII)) indicated for use in adults and children with hemophilia A for: On-d...

Novoseven Rt (coagulation Factor Viia- Recombinant Kit

NOVOSEVEN RT, Coagulation Factor VIIa (Recombinant), is indicated for: Treatment of bleeding episodes and peri-operative management in adults and children with hemophilia A or B with inhibitors, ...

Nplate- Romiplostim Injection, Powder, Lyophilized, For Solution

Nplate is indicated for the treatment of thrombocytopenia in: Adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to cortico...

Nucala- Mepolizumab Injection, Powder, For Solutionnucala- Mepolizumab Injection, Solution

1.1 Maintenance Treatment of Severe Asthma NUCALA is indicated for the add-on maintenance treatment of patients with severe asthma aged 6 years and older, and with an eosinophilic phenotype [see Use ...

Nuedexta- Dextromethorphan Hydrobromide And Quinidine Sulfate Capsule, Gelatin Coated

NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, an...

Nulojix- Belatacept Injection, Powder, Lyophilized, For Solution

1.1 Adult Kidney Transplant Recipients NULOJIX (belatacept) is indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant. NULOJIX is to be used in combination wit...

Nutrilipid I.v. Fat Emulsion- Soybean Oil Injection, Solution

Nutrilipid 20% is indicated as a source of calories and essential fatty acids for parenteral nutrition and as a source of essential fatty acids when a deficiency occurs when oral or enteral nutritio...

Nutropin Aq Pen 10- Somatropin Injection, Solutionnutropin Aq Pen 20- Somatropin Injection, Solutionnutropin Aq Nuspin 5- Somatropin Injection, Solutionnutropin Aq Nuspin 10- Somatropin Injection, Solutionnutropin Aq Nuspin 20- Somatropin Injection, Solution

1.1 Pediatric Patients Growth Hormone Deficiency (GHD) - Nutropin AQ is indicated for the treatment of pediatric patients who have growth failure due to inadequate secretion of endogenous gr...

Nyamyc- Nystatin Powder

Nyamyc (Nystatin Topical Powder, USP) is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nyamyc (Nysta...

Nystatin And Triamcinolone Acetonide Cream

Nystatin and Triamcinolone Acetonide Cream and Ointment are indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefi...

Nystatin And Triamcinolone Acetonide Creamnystatin And Triamcinolone Acetonide Ointment

Nystatin and Triamcinolone Acetonide Cream and Ointment are indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefi...

Nystatin And Triamcinolone Acetonide- Nystatin And Triamcinolone Acetonide Cream

Nystatin and Triamcinolone Acetonide Cream, USP is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than th...

Nystatin And Triamcinolone Acetonide- Nystatin And Triamcinolone Acetonide Ointment

Nystatin and Triamcinolone Acetonide Ointment is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the ...

Nystatin And Triamcinolone Acetonide- Nystatin, Triamcinolone Acetonide Cream

Nystatin and Triamcinolone Acetonide Cream is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nys...

Nystatin And Triamcinolone- Nystatin And Triamcinolone Acetonide Cream

Nystatin and Triamcinolone Acetonide Cream and Ointment are indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefi...

Nystatin- Nystatin Cream

Nystatin Cream, USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This cream is not indicated for sys...

Nystatin- Nystatin Cream Cream

Nystatin Cream, USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This cream is not indicated for sys...

Nystatin- Nystatin Ointment Ointment

Nystatin Ointment, USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candidaspecies. Nystatin Ointment, USP is not i...

Nystatin- Nystatin Powder

Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This topical powder is not indi...

O

Ob Complete 400- Fish Oil, Doconexent, Omega-3 Fatty Acids, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Folic Acid, Cholecalciferol, Calcium Ascorbate, Calcium Threonate, .alpha.-tocopherol, D-, Niacin, Cupric Sulfate Anhydrous, Zinc Oxide, Iron Pentacarbonyl, And Ferrous Asparto Glycinate Capsule, Liquid Filled

OB Complete 400 is a prescription multivitamin/multimineral indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for...

Ocaliva- Obeticholic Acid Tablet, Film Coated

OCALIVA is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults...

Ocrevus- Ocrelizumab Injection

OCREVUS is indicated for the treatment of: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, ...

Octreotide Acetate Injection

AcromegalyOctreotide acetate injection is indicated to reduce blood levels of growth hormone and IGF-I (somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated w...

Octreotide Acetate Injection, Solution

AcromegalyOctreotide acetate injection is indicated to reduce blood levels of growth hormone and IGF-I (somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated w...

Octreotide- Octreotide Acetate Injection, Solution

Acromegaly Octreotide Acetate Injection is indicated to reduce blood levels of growth hormone and IGF-I (somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated ...

Octreotide- Octreotide Acetate Injection, Solutionoctreotide- Octreotide Acetate Injection, Solution

Acromegaly Octreotide Acetate Injection is indicated to reduce blood levels of growth hormone and IGF-I (somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated ...

Odomzo- Sonidegib Capsule

ODOMZO (sonidegib) is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not cand...

Ogivri- Trastuzumab Kitogivri- Trastuzumab Injection, Powder, Lyophilized, For Solution

1.1 Adjuvant Breast Cancer Ogivri is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies (14.1)]...

Olumiant- Baricitinib Tablet, Film Coated

1.1 Rheumatoid Arthritis OLUMIANT (baricitinib) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one o...

Omniscan- Gadodiamide Injection

1.1 CNS (Central Nervous System) OMNISCAN is a gadolinium-based contrast agent indicated for intravenous use in MRI to visualize lesions with abnormal vascularity (or those thought to cause abnormalit...

Omnitrope- Somatropin Injection, Solutionomnitrope- Somatropin Kit

1.1 Pediatric Patients Omnitrope (somatropin) injection is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (GH). Omnitrope (somatro...

Oncaspar- Pegaspargase Injection, Solution

1.1 First-Line Acute Lymphoblastic Leukemia (ALL) ONCASPAR is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with ALL...

Oncaspar- Pegaspargase Injection, Solution For Intramuscular And Intravenous Use

1.1 First Line Acute Lymphoblastic Leukemia (ALL) Oncaspar is indicated as a component of a multi-agent chemotherapeutic regimen for the first line treatment of patients with ALL. 1.2 Acute Lymph...

Opdivo- Nivolumab Injection

1.1 Unresectable or Metastatic Melanoma OPDIVO, as a single agent or in combination with ipilimumab, is indicated for the treatment of patients with unresectable or metastatic melanoma. 1.2 Adjuva...

Opsumit- Macitentan Tablet, Film Coated

1.1 Pulmonary Arterial Hypertension OPSUMIT is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to reduce the risks of disease...

Orbactiv- Oritavancin Injection, Powder, Lyophilized, For Solution

1.1 Acute Bacterial Skin and Skin Structure Infections ORBACTIV (oritavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections ...

Orencia- Abatacept Injection, Powder, Lyophilized, For Solutionorencia- Abatacept Injection, Solution

1.1 Adult Rheumatoid Arthritis (RA) ORENCIA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical f...

Orenitram- Treprostinil Tablet, Extended Release

1.1 Pulmonary Arterial Hypertension Orenitram is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. The study that established effectiven...

Orfadin- Nitisinone Capsule

ORFADIN is indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine....

Orfadin- Nitisinone Suspension

ORFADIN is indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine....

Orkambi- Lumacaftor And Ivacaftor Tablet, Film Coatedorkambi- Lumacaftor And Ivacaftor Granule

ORKAMBI is a combination of lumacaftor and ivacaftor indicated for the treatment of cystic fibrosis (CF) in patients age 2 years and older who are homozygous for the F508del mutation in the CFTR gene....

Oseni- Alogliptin And Pioglitazone Tablet, Film Coated

1.1 Monotherapy and Combination Therapy OSENI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both alogliptin an...

Osphena- Ospemifene Tablet, Film Coated

OSPHENA is indicated for: 1.1 The Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, Due to Menopause. 1.2 The Treatment of Moderate to Severe Vaginal Dryness,...

Oxsoralen-ultra- Methoxsalen Capsule, Liquid Filled

Photochemotherapy (methoxsalen with long-wave UVA radiation) is indicated for the symptomatic control of severe, recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy a...

Oxytocin Injection

IMPORTANT NOTICEOxytocin is indicated for the medical rather than the elective induction of labor. Available data and information are ...

Oxytocin Injection, Solution

IMPORTANT NOTICE: Oxytocin Injection, USP (synthetic) is indicated for the medical rather than the elective induction of labor. Available data and information are inadequate to define ...

Ozempic- Semaglutide Injection, Solution

OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies ( 14.1)] . ...

P

Pancuronium Bromide Injection, Solution

Pancuronium bromide is indicated as an adjunct to general anesthesia to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation....

Parakeet Feather Injection, Solution

Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic sympto...

Parcopa- Carbidopa And Levodopa Tablet, Orally Disintegrating

PARCOPA is indicated in the treatment of the symptoms of idiopathic Parkinson s disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism which may follow injury t...

Parnate- Tranylcypromine Sulfate Tablet, Film Coated

PARNATE is indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. PARNATE is not indicated for the initial treatme...

Parsabiv- Etelcalcetide Injection, Solution

PARSABIV is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. Limitations of Use: PARSABIV has not been studied...

Pediarix (diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed, Hepatitis B- Recombinant And Inactivated Poliovirus Vaccine Combined Injection, Suspension

PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a ...

Pediatric Infuvite Multiple Vitamins For Infusion- Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin 5-phosphate Sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol Acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin Injection, Solution

INFUVITE PEDIATRIC is a combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition. The physician should not ...

Pediatric Infuvite Multiple Vitamins- Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 Phosphate Sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol Acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin Kit

INFUVITE PEDIATRIC is a combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition. The physician should not ...

Pediatric Infuvite Multiple Vitamins- Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 Phosphate Sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol Acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin Kitpediatric Infuvite Multiple Vitamins- Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 Phosphate Sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol Acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin Injection, Solution

INFUVITE PEDIATRIC is a combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition. The physician should not ...

Pedvaxhib (haemophilus B Conjugate Vaccine- Meningococcal Protein Conjugate Injection, Suspension

Liquid PedvaxHIB is indicated for routine vaccination against invasive disease caused by Haemophilus influenzae type b in infants and children 2 to 71 months of age. Liquid PedvaxHIB will not protect...

Pegasys- Peginterferon Alfa-2a Injection, Solution

1.1 Chronic Hepatitis C (CHC) Adult Patients: PEGASYS, as part of a combination regimen with other hepatitis C virus (HCV) antiviral drugs, is indicated for the treatment of adults with CHC and comp...

Pegintron- Peginterferon Alfa-2b Injection, Powder, Lyophilized, For Solutionpegintron- Peginterferon Alfa-2b Kit

1.1 Chronic Hepatitis C (CHC) PEGINTRON , as part of a combination regimen, is indicated for the treatment of Chronic Hepatitis C (CHC) in patients with compensated liver disease. PEGINTRON in com...

Pentacel (diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed, Inactivated Poliovirus And Haemophilus B Conjugate- Tetanus Toxoid Conjugate Vaccine Kit

Pentacel is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b. Pentacel is approved for use...

Pentazocine And Naloxone Tablet

Pentazocine and Naloxone Hydrochloride Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations o...

Pentazocine And Naloxone- Pentazocine Hydrochloride And Naloxone Hydrochloride Tablet

Pentazocine and naloxone hydrochlorides tablets are intended for oral use only. Severe, potentially lethal, reactions may result from misuse of pentazocine and naloxone hydrochlorides tablets by injec...

Pentazocine Hcl And Acetaminophen- Pentazocine Hydrochloride And Acetaminophen Tablet

Pentazocine hydrochloride and acetaminophen tablets are indicated for the relief of mild to moderate pain....

Pentazocine Hydrochloride And Acetaminophen Tablet

Pentazocine Hydrochloride and Acetaminophen Tablets are indicated for the relief of mild to moderate pain....

Pentazocine Hydrochloride And Naloxone Hydrochloride Tablet

Pentazocine Hydrochloride and Naloxone Hydrochloride Tablets, USP is indicated for the relief of moderate to severe pain. Pentazocine Hydrochloride and Naloxone Hydrochloride Tablets, USP is indicated...

Pentetate Calcium Trisodium Injection, Solution, Concentrate

Ca-DTPA is indicated for treatment of individuals with known or suspected internal contamination with plutonium, americium, or curium to increase the rates of elimination....

Pentetate Calcium Trisodium- Pentetate Calcium Trisodium Injection, Solution, Concentrate

Ca-DTPA is indicated for treatment of individuals with known or suspected internal contamination with plutonium, americium, or curium to increase the rates of elimination....

Pentetate Zinc Trisodium Injection, Solution, Concentrate

Zn-DTPA is indicated for treatment of individuals with known or suspected internal contamination with plutonium, americium, or curium to increase the rates of elimination....

Pentetate Zinc Trisodium- Pentetate Zinc Trisodium Injection, Solution, Concentrate

Zn-DTPA is indicated for treatment of individuals with known or suspected internal contamination with plutonium, americium, or curium to increase the rates of elimination....

Pentoxifylline Tablet, Extended Release

Pentoxifylline extended-release tablets, USP are indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Pentoxifylline ...

Perikabiven- Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine Injection, Emulsion

PERIKABIVEN is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not...

Perjeta- Pertuzumab Injection, Solution, Concentrate

1.1 Metastatic Breast Cancer (MBC) PERJETA is indicated for use in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not rec...

Permax- Pergolide Tablet

Permax is indicated as adjunctive treatment to levodopa/carbidopa in the management of the signs and symptoms of Parkinson's disease. Evidence to support the efficacy of pergolide as an antiparkinsoni...

Permethrin Cream

Permethrin Cream, 5% is indicated for the treatment of infestation with Sarcoptes scabiei (scabies)....

Permethrin- Permethrin Cream 5% W/w Cream

Permethrin Cream 5% w/w is indicated for the treatment of infestation with Sarcoptesscabiei (scabies)....

Phenelzine Sulfate Tablet

Phenelzine Sulfate Tablets, USP has been found to be effective in depressed patients clinically characterized as "atypical," "nonendogenous," or "neurotic." These patients often have mixed anxiety and...

Phenelzine Sulfate Tablet, Film Coated

Phenelzine sulfate has been found to be effective in depressed patients clinically characterized as "atypical," "nonendogenous," or "neurotic." These patients often have mixed anxiety and depression a...

Phosphasal- Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate Tablet

Phosphasal tablets are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, whic...

Photofrin- Porfimer Sodium Injection, Powder, For Solution

Photodynamic therapy with PHOTOFRIN is indicated for: Palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in th...

Phytonadione Injection, Emulsion

Phytonadione injectable emulsion, USP is indicated in the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by Vitamin K deficiency or interfer...

Phytonadione Injection, Emulsionphytonadione Injection, Emulsion

1.1 Treatment of Hypoprothrombinemia Due to Vitamin K Deficiency or Interference Phytonadione is indicated for the treatment of the following coagulation disorders which are due to faulty formation of...

Picato- Ingenol Mebutate Gel

Picato gel is indicated for the topical treatment of actinic keratosis....

Pilocarpine Hydrochloride Solution/ Drops

Pilocarpine hydrochloride ophthalmic solution is indicated for the: 1.1 Reduction of Elevated Intraocular Pressure (IOP) in Patients with Open-Angle Glaucoma or Ocular Hypertension 1.2 Manageme...

Pilocarpine Hydrochloride Tablet

Pilocarpine HCl Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of sym...

Pilocarpine Hydrochloride Tablet, Film Coated

Pilocarpine hydrochloride tablets, USP are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the t...

Pilocarpine Hydrochloride Tablet, Film Coatedpilocarpine Hydrochloride Tablet, Film Coated

Pilocarpine hydrochloride tablets, USP are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the t...

Pilocarpine Hydrochloride- Pilocarpine Hydrochloride Solution/ Drops

Pilocarpine Hydrochloride Ophthalmic Solution is indicated for the: 1.1 Reduction of Elevated Intraocular Pressure (IOP) in Patients with Open-Angle Glaucoma or Ocular Hypertension 1.2 Managemen...

Pioglitazole And Metformin Hydrochloride Tablet

Pioglitazone and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both pioglitaz...

Pioglitazone And Glimepiride Tablet

Pioglitazone and glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedio...

Pioglitazone And Metformin Tablet, Film Coated

Pioglitazone and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both pioglitaz...

Pioglitazone Hcl And Metformin Hcl Tablet

Pioglitazone and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both pioglitaz...

Pioglitazone- Pioglitazone Tablet

Monotherapy and Combination Therapy Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple...

Pitocin- Oxytocin Injection

IMPORTANT NOTICE Elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. Since the available data are inadequate to eva...

Pitocin- Oxytocin Injection

IMPORTANT NOTICE Elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. Since the available data are inadequate to eva...

Pneumovax 23- Pneumococcal Vaccine Polyvalent Injection, Solution

1.1 Indications and Use PNEUMOVAX 23 is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B,...

Podofilox Solution

Podofilox 0.5% Solution is indicated for the topical treatment of external genital warts (Condyloma acuminatum). This product is not indicated in the treatment of perianal or mucous membrane warts (se...

Polymyxin B Sulfate And Trimethoprim Solution

Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, cau...

Polymyxin B Sulfate And Trimethoprim- Polymyxin B Sulfate And Trimethoprim Sulfate Solution/ Drops

Polymyxin B sulfate and trimethoprim ophthalmic solution is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, cau...

Pomalyst- Pomalidomide Capsule

1.1 Multiple Myeloma POMALYST, in combination with dexamethasone, is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome...

Portrazza- Necitumumab Solution

1.1 Squamous Non-Small Cell Lung Cancer (NSCLC) PORTRAZZA is indicated, in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell ...

Pralidoxime Chloride Injection

This auto-injector for pralidoxime chloride is specifically indicated for intramuscular use as an adjunct to atropine in the treatment of poisoning by nerve agents having anticholinesterase activity....

Praluent- Alirocumab Injection, Solution

1.1 Prevention of Cardiovascular Events PRALUENT is indicated to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovas...

Pramipexole Dihydrochloride Extended-release- Pramipexole Tablet, Extended Release

Pramipexole Dihydrochloride Extended-Release Tablets are indicated for the treatment of Parkinson's disease....

Pramipexole Dihydrochloride Tablet

1.1 Parkinson's Disease Pramipexole dihydrochloride tablets are indicated for the treatment Parkinson's disease. 1.2 Restless Legs Syndrome Pramipexole dihydrochloride tablets are indicated for th...

Prandin- Repaglinide Tablet

PRANDIN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitation of Use: PRANDIN should not be used in patients wi...

Praxbind- Idarucizumab Injection

PRAXBIND is indicated in patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed: For emergency surgery/urgent procedures In life-threatening or uncontrolled ...

Precose- Acarbose Tablet

PRECOSE is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus....

Prevnar 13- Pneumococcal 13-valent Conjugate Vaccine Injection, Suspension

1.1 Children 6 Weeks Through 5 Years of Age In children 6 weeks through 5 years of age (prior to the 6th birthday), Prevnar 13 is indicated for: active immunization for the prevention of invasive d...

Prevymis- Letermovir Tablet, Film Coatedprevymis- Letermovir Injection, Solution

PREVYMIS is indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT)....

Prezcobix- Darunavir Ethanolate And Cobicistat Tablet, Film Coated

PREZCOBIX is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-na ve and treatment-experienced ...

Prialt- Ziconotide Acetate Injection, Solution

PRIALT (ziconotide) solution, intrathecal infusion is indicated for the management of severe chronic pain in adult patients for whom intrathecal therapy is warranted, and who are intolerant of or refr...

Prialt- Ziconotide Injection, Solution

PRIALT (ziconotide) solution, intrathecal infusion is indicated for the management of severe chronic pain in adult patients for whom intrathecal therapy is warranted, and who are intolerant of or refr...

Priftin- Rifapentine Tablet, Film Coated

1.1 Active Pulmonary Tuberculosis PRIFTIN (rifapentine) is indicated in adults and children 12 years and older for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tubercu...

Primaxin Iv- Imipenem And Cilastatin Sodium Injection, Powder, For Solution

1.1 Lower Respiratory Tract Infections PRIMAXIN for intravenous use is indicated for the treatment of lower respiratory tract infections caused by susceptible strains of Staphylococcus aureus (penici...

Probenecid And Colchicine Tablet

For the treatment of chronic gouty arthritis when complicated by frequent, recurrent acute attacks of gout....

Procrit- Erythropoietin Injection, Solution

1.1 Anemia Due to Chronic Kidney Disease PROCRIT is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis to decrease the need f...

Procysbi- Cysteamine Bitartrate Capsule, Delayed Release Pellets

PROCYSBI is indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older....

Prohance- Gadoteridol Injection, Solution

1.1 MRI of the Central Nervous System (CNS) ProHance is indicated for use in magnetic resonance imaging (MRI) in adults and pediatric patients over 2 years of age to visualize lesions with abnormal ...

Prolastin-c (alpha-1-proteinase Inhibitor- Human Kitprolastin-c (alpha-1-proteinase Inhibitor- Human Kit

PROLASTIN-C is an Alpha1-Proteinase Inhibitor (Human) (Alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary defi...

Prolastin-c Liquid (alpha1-proteinase Inhibitor- Human Injection, Solution

PROLASTIN-C LIQUID is an Alpha1-Proteinase Inhibitor (Human) (Alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe heredita...

Proleukin- Aldesleukin Injection, Powder, Lyophilized, For Solution

Proleukin (aldesleukin) is indicated for the treatment of adults with metastatic renal cell carcinoma (metastatic RCC). Proleukin is indicated for the treatment of adults with metastatic melanoma. C...

Prolia- Denosumab Injection

1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fractur...

Promacta- Eltrombopag Olamine Tablet, Film Coatedpromacta- Eltrombopag Olamine Powder, For Suspension

1.1 Treatment of Thrombocytopenia in Patients with Chronic ITP PROMACTA is indicated for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune thromboc...

Proquad- Measles, Mumps, Rubella And Varicella Virus Vaccine Live Injection, Powder, Lyophilized, For Suspension

ProQuad is a vaccine indicated for active immunization for the prevention of measles, mumps, rubella, and varicella in children 12 months through 12 years of age....

Prostin Vr Pediatric- Alprostadil Injection, Solution

PROSTIN VR PEDIATRIC Sterile Solution is indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be pe...

Protamine Sulfate Injection, Solution

Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage....

Protopam Chloride- Pralidoxime Chloride Injection, Powder, Lyophilized, For Solution

PROTOPAM Chloride is indicated as an antidote: 1. In the treatment of poisoning due to those pesticides and chemicals (e.g., nerve agents) of the organophosphate class which have anticholinesterase a...

Provayblue- Methylene Blue Injection

PROVAYBLUE USP is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. This indication is approved under accelerated approval. Continued approval for th...

Provenge- Sipuleucel-t Injection

PROVENGE (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) p...

Pulmozyme- Dornase Alfa Solution

PULMOZYME (dornase alfa) is indicated for daily administration in conjunction with standard therapies for the management of cystic fibrosis (CF) patients to improve pulmonary function. In CF patient...

Q

Qtern- Dapagliflozin And Saxagliptin Tablet, Film Coated

QTERN (dapagliflozin and saxagliptin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use QTERN is not indicated for...

Quadracel- Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus Vaccine Injection, Suspension

Quadracel is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis. A single dose of Quadracel is approved for use in children 4 through 6 years of age...

Quelicin- Succinylcholine Chloride Injection, Solution

Succinylcholine chloride is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation....

Quinidine Gluconate Tablet, Extended Release

Conversion of atrial fibrillation/flutter In patients with symptomatic atrial fibrillation/flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular response...

Quinidine Gluconate- Quinidine Gluconate Tablet, Extended Release

Conversion of Atrial Fibrillation/ Flutter In patients with symptomatic atrial fibrillation/flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular respons...

Quinidine Sulfate Tablet

Conversion of atrial fibrillation/flutter In patients with symptomatic atrial fibrillation/flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular response...

R

Rabavert- Rabies Vaccine Kit

RabAvert is indicated for preexposure vaccination, in both primary series and booster dose, and for postexposure prophylaxis against rabies in all age groups. Usually an immunization series is initia...

Radiogardase- Prussian Blue Insoluble Capsules Capsule

Radiogardase is indicated for treatment of patients with known or suspected internal contamination with radioactive cesium and/or radioactive or non-radioactive thallium, in order to increase their ra...

Raloxifene Hydrochloride Tablet

1.1 Treatment of Osteoporosis in Postmenopausal Women Raloxifene hydrochloride tablets, USP are indicated for the treatment of osteoporosis in postmenopausal women [see Clinical Studies (14.1)]....

Raloxifene Hydrochloride- Raloxifene Tablet

1.1 Treatment and Prevention of Osteoporosis in Postmenopausal Women Raloxifene hydrochloride tablets, USP are indicated for the treatment and prevention of osteoporosis in postmenopausal women [see C...

Ramelteon Tablet

Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The...

Ranexa- Ranolazine Tablet, Film Coated, Extended Release

RANEXA is indicated for the treatment of chronic angina. RANEXA may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and...

Ranolazine Tablet, Extended Release

Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-pla...

Ranolazine Tablet, Film Coated, Extended Release

Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-plat...

Rapamune- Sirolimus Solutionrapamune- Sirolimus Tablet, Sugar Coated

1.1 Prophylaxis of Organ Rejection in Renal Transplantation Rapamune (sirolimus) is indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants. In...

Rasagiline Mesylate Tablet

Rasagiline tablets are indicated for the treatment of Parkinson s disease (PD)....

Rasagiline Tablet

Rasagiline tablets are indicated for the treatment of Parkinson's disease (PD)...

Rasagiline- Rasagiline Tablet

Rasagiline tablets are indicated for the treatment of Parkinson's disease (PD)....

Raxibacumab Injection

1.1 Inhalational Anthrax Raxibacumab is indicated for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial d...

Rebetol- Ribavirin Capsulerebetol- Ribavirin Liquid

1.1 Chronic Hepatitis C (CHC) REBETOL (ribavirin) in combination with interferon alfa-2b (pegylated and nonpegylated) is indicated for the treatment of Chronic Hepatitis C (CHC) in patients 3 years ...

Rebif- Interferon Beta-1a Kitrebif Rebidose- Interferon Beta-1a Kitrebif- Interferon Beta-1a Injection, Solutionrebif- Interferon Beta-1a Injection, Solutionrebif Rebidose- Interferon Beta-1a Injection, Solution

REBIF is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in a...

Rebinyn ((coagulation Factor Ix- Recombinant, Glycopegylated Kit

REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B for: On-dem...

Recombinate- Antihemophilic Factor Recombinant Kit

The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated ...

Recombivax Hb (hepatitis B Vaccine- Recombinant Injection, Suspension

RECOMBIVAX HB [Hepatitis B Vaccine, Recombinant] is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. RECOMBIVAX HB is approved for use in individuals of all a...

Regranex- Becaplermin Gel

REGRANEX is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply, when used as an adjunct to,...

Relenza- Zanamivir Powder

1.1 Treatment of Influenza RELENZA (zanamivir) inhalation powder is indicated for treatment of uncomplicated acute illness due to influenza A and B virus in adults and pediatric patients aged 7 years...

Remicade- Infliximab Injection, Powder, Lyophilized, For Solution

1.1 Crohn's Disease REMICADE is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have ...

Remodulin- Treprostinil Injection, Solutionsterile Diluent For Remodulin- Water Injection, Solution

1.1 Pulmonary Arterial Hypertension Remodulin is indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing e...

Renacidin- Citric Acid, Gluconolactone And Magnesium Carbonate Solution

Renacidin is indicated for dissolution of bladder calculi of the struvite or apatite variety by local intermittent irrigation through a urethral catheter or cystostomy tube as an alternative or adjunc...

Renese-r- Polythiazide And Reserpine Tablet

Hypertension (see box warning). Usage in Pregnancy The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not pr...

Renflexis- Infliximab Injection, Powder, Lyophilized, For Solution

1.1 Crohn's Disease RENFLEXIS is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have...

Repaglinide And Metformin Hydrochloride Tablet

Repaglinide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a glin...

Repaglinide Tablet

Repaglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitation of Use: Repaglinide tablets should not be used in p...

Repatha- Evolocumab Injection, Solutionrepatha- Evolocumab Kit

1.1 Prevention of Cardiovascular Events In adults with established cardiovascular disease, REPATHA is indicated to reduce the risk of myocardial infarction, stroke, and coronary revasc...

Retacrit- Epoetin Alfa-epbx Injection, Solution

1.1 Anemia Due to Chronic Kidney Disease RETACRIT is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis to decrease the need ...

Revlimid- Lenalidomide Capsule

1.1 Multiple Myeloma REVLIMID in combination with dexamethasone is indicated for the treatment of adult patients with multiple myeloma (MM). REVLIMID is indicated as maintenance therapy in adult patie...

Revonto- Dantrolene Sodium Injection, Powder, Lyophilized, For Solution

Revonto (dantrolene sodium for injection) is indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant h...

Reyataz Capsule, Gelatin Coated

REYATAZ (atazanavir) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 3 months and older weighing at least 5 kg. Limitations of Use: ...

Reyataz- Atazanavir Capsule, Gelatin Coated

REYATAZ (atazanavir) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 3 months and older weighing at least 5 kg. Limitations of Use: ...

Reyataz- Atazanavir Capsule, Gelatin Coatedreyataz- Atazanavir Powder

REYATAZ (atazanavir) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 3 months and older weighing at least 5 kg. Limitations of Use: ...

Reyataz- Atazanavir Sulfate Capsule, Gelatin Coated

REYATAZ (atazanavir sulfate) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on analyses of plasma HIV-1 RNA levels and CD...

Rhogam Ultra-filtered Plus (human Rho- D Immune Globulin Injection, Solutionmicrhogam Ultra-filtered Plus (human Rho- D Immune Globulin Injection, Solution

1.1 Pregnancy and other obstetrical conditions RhoGAM and MICRhoGAM are indicated for administration to Rh-negative women not previously sensitized to the Rho(D) factor, unless the father or baby are ...

Rhophylac (human Rho- D Immune Globulin Solution

Rhophylac is an Rh0(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the suppression of Rh isoimmunization in non-sensitized Rh0(D)-negative patients and for the treatment...

Rhopressa- Netarsudil Solution/ Drops

RHOPRESSA (netarsudil ophthalmic solution) 0.02% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension....

Riastap- Fibrinogen Human Injection, Powder, Lyophilized, For Solution

RiaSTAP , Fibrinogen Concentrate (Human) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibri...

Ribavirin Capsule

1.1 Chronic Hepatitis C (CHC) Ribavirin capsules in combination with interferon alfa-2b (pegylated and nonpegylated) are indicated for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of...

Rifabutin Capsule

Rifabutin capsules USP are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection....

Rifadin Iv Novaplus- Rifampin Injection, Powder, Lyophilized, For Solution

In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant ...

Rifadin- Rifampin Capsulerifadin Iv- Rifampin Injection, Powder, Lyophilized, For Solution

In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant ...

Rifamate- Rifampin And Isoniazid Capsule

In the treatment of tuberculosis, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Since resistance can emerge rapidly...

Rifampin Capsule

In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant ...

Rilutek- Riluzole Tablet

RILUTEK is indicated for the treatment of amyotrophic lateral sclerosis (ALS)....

Riluzole Tablet

Riluzole is indicated for the treatment of amyotrophic lateral sclerosis(ALS)....

Riluzole Tablet, Film Coated

Riluzole tablets, USP are indicated for the treatment of amyotrophic lateral sclerosis (ALS)....

Ritonavir Tablet

tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Ritonavir tablets are indicated in combination with other antiretroviral agents for t...

Ritonavir Tablet, Film Coated

Ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection....

Rituxan Hycela- Rituximab And Hyaluronidase Injection, Solution

1.1 Follicular Lymphoma (FL) RITUXAN HYCELA is indicated for the treatment of adult patients with: Relapsed or refractory, follicular lymphoma as a single agent. Previously untreated follicular lymph...

Rituxan- Rituximab Injection, Solution

1.1 Non Hodgkin's Lymphoma (NHL) RITUXAN (rituximab) is indicated for the treatment of adult patients with: Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single ag...

Rixubis (coagulation Factor Ix- Recombinant Kit

RIXUBIS (Coagulation Factor IX [Recombinant]) is an antihemophilic factor indicated in adults and children with hemophilia B for: Control and prevention of bleeding episodes, perioperative management,...

Rocklatan- Netarsudil And Latanoprost Ophthalmic Solution, 0.02%/0.005% Solution/ Drops

ROCKLATAN (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% is a fixed dose combination of a Rho kinase inhibitor and a prostaglandin F2 analogue indicated for the reduction of elevated ...

Rocuronium- Rocuronium Bromide Injection, Solution

Rocuronium Bromide Injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal ...

Romidepsin Kit

1.1 Cutaneous T-Cell Lymphoma Romidepsin is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy. 1.2 Peripheral T...

Rotarix- Rotavirus Vaccine, Live, Oral Kit

ROTARIX is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series [see Clinical Studies (14.3)]. ROTARIX is appro...

Rotateq- Rotavirus Vaccine, Live, Oral, Pentavalent Solution

RotaTeq is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by types G1, G2, G3, G4, and G9 when administered as a 3-dose series to infants between the ages o...

Rozerem- Ramelteon Tablet, Film Coated

ROZEREM is indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to 6 months in duration. The final fo...

Rubraca- Rucaparib Tablet, Film Coated

1.1 Maintenance Treatment of Recurrent Ovarian Cancer Rubraca is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal can...

Ruzurgi- Amifampridine Tablet

RUZURGI is indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to less than 17 years of age....

Ryanodex Dantrolene Sodium- Dantrolene Sodium Injection, Suspension

RYANODEX is indicated for the: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures [see Dosage and Administration (2.1)] Prevention of malignant hyperthermia in...

Rybelsus- Oral Semaglutide Tablet

RYBELSUS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1)]. Limitations of Use RYBELSUS is not reco...

Rydapt Capsule, Liquid Filled

1.1 Acute Myeloid Leukemia RYDAPT is indicated, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy, for the treatment of adult patients with n...

S

Saizen- Somatropin Kitsaizen Clickeasy- Somatropin Kitsaizenprep- Somatropin Kit

1.1 Pediatric Patients SAIZEN (somatropin) is indicated for the treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone. 1.2 Adult Patients SAIZ...

Samsca- Tolvaptan Tablet

SAMSCA is indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and ...

Sandostatin Lar Depot- Octreotide Acetate Kit

SANDOSTATIN LAR DEPOT 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated. 1.1 Acrome...

Sandostatin- Octreotide Acetate Injection, Solution

Acromegaly Sandostatin (octreotide acetate) is indicated to reduce blood levels of growth hormone and IGF-I (somatomedin C) in acromegaly patients who have had inadequate response to or cannot be tr...

Savaysa- Edoxaban Tosylate Tablet, Film Coated

1.1 Reduction in the Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation SAVAYSA is indicated to reduce the risk of stroke and systemic embolism (SE) in patients with...

Saxenda- Liraglutide Injection, Solution

Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or ...

Se-tan Plus- Multivitamin/mineral Capsule, Gelatin Coated

Se-Tan PLUS is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age. Also fo...

Selegiline Hydrochloride Capsule

Selegiline capsules, USP are indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this...

Selegiline Hydrochloride Tablet

Selegiline Hydrochloride Tablets USP are indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their resp...

Selzentry- Maraviroc Tablet, Film Coated

SELZENTRY is indicated in combination with other antiretroviral agents for the treatment of only CCR5-tropic human immunodeficiency virus type 1 (HIV-1) infection in patients 2 years of age and older ...

Selzentry- Maraviroc Tablet, Film Coatedselzentry- Maraviroc Solution

SELZENTRY is indicated in combination with other antiretroviral agents for the treatment of only CCR5-tropic human immunodeficiency virus type 1 (HIV-1) infection in patients 2 years of age and older ...

Sensipar- Cinacalcet Hydrochloride Tablet, Coated

1.1 Secondary Hyperparathyroidism Sensipar is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis [see Cl...

Sentrazolpidem Pm-5- Zolpidem Tartrate, Choline Kit

1. INDICATIONS AND USAGEZolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown ...

Serostim- Somatropin Kit

SEROSTIM (somatropin) is indicated for the treatment of HIV patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance. Concomitant antiretroviral the...

Signifor Lar- Pasireotide Kit

1.1 Acromegaly SIGNIFOR LAR is indicated for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. 1.2 ...

Signifor- Pasireotide Injection

1.1 Cushing s Disease SIGNIFOR is indicated for the treatment of adult patients with Cushing s disease for whom pituitary surgery is not an option or has not been curative....

Siliq- Brodalumab Injection

SILIQ is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost respons...

Simponi Aria- Golimumab Solution

1.1 Rheumatoid Arthritis (RA) SIMPONI ARIA, in combination with methotrexate (MTX), is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis. 1.2 ...

Simponi- Golimumab Injection, Solution

1.1 Rheumatoid Arthritis SIMPONI, in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis. 1.2 Psoriat...

Simulect- Basiliximab Injection, Powder, For Solution

Simulect (basiliximab) is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclospo...

Sincalide Injection, Powder, Lyophilized, For Solution

Sincalide may be used: to stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis...

Sirolimus Solution

1.1 Prophylaxis of Organ Rejection in Renal Transplantation Sirolimus Oral Solution is indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants. ...

Sirolimus Tablet

1.1 Prophylaxis of Organ Rejection in Renal Transplantation Sirolimus tablets are indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants. In pa...

Sirolimus Tablet, Film Coated

1.1 Prophylaxis of Organ Rejection in Renal Transplantation Sirolimus tablets are indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants. In p...

Sirolimus Tablet, Sugar Coated

1.1 Prophylaxis of Organ Rejection in Renal Transplantation Sirolimus is indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants. In patients at...

Sirturo- Bedaquiline Fumarate Tablet

SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adult and pediatric patients (12 to less than 18 years of age and weighing at least 30 ...

Sklice- Ivermectin Lotion

1.1 Indication SKLICE Lotion is indicated for the topical treatment of head lice infestations in patients 6 months of age and older. 1.2 Adjunctive Measures SKLICE Lotion should be used in the ...

Smoflipid Injection, Emulsion

Smoflipid is indicated in adults as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Limitat...

Sodium Iodide I 131 Diagnostic- Sodium Iodide I 131 Capsule

Sodium Iodide I 131 Capsules Diagnostic is indicated for use in adults for: Assessment of thyroid function using radioactive iodine (RAI) uptake test Imaging the thyroid (scintigraphy)...

Sodium Iodide I-131 Solution, Concentrate

Sodium Iodide I-131 is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma....

Sodium Phenylacetate And Sodium Benzoate Injection, Solution, Concentrate

Sodium Phenylacetate and Sodium Benzoate Injection 10% / 10% is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia and associated encephalopathy ...

Sodium Phenylbutyrate Powder

Sodium phenylbutyrate powder is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine ...

Sodium Phenylbutyrate- Sodium Phenylbutyrate Tablets, 500 Mg Tablet

Sodium Phenylbutyrate Tablets is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine...

Sofosbuvir And Velpatasvir- Velpatasvir And Sofosbuvir Tablet, Film Coated

Sofosbuvir and velpatasvir tablets are indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection [see Dosage and Administration (2.2) an...

Soliqua 100/33- Insulin Glargine And Lixisenatide Injection, Solution

SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitati...

Soliris- Eculizumab Injection, Solution, Concentrate

1.1 Paroxysmal Nocturnal Hemoglobinuria (PNH) Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. 1.2 Atypical Hemolytic Uremic Sy...

Somatuline Depot- Lanreotide Acetate Injection

1.1 Acromegaly SOMATULINE DEPOT is indicated for the long-term treatment of acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiothe...

Somavert- Pegvisomant Kit

SOMAVERT is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. The goal of trea...

Sonata- Zaleplon Capsule

Sonata is indicated for the short-term treatment of insomnia. Sonata has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under CL...

Soolantra- Ivermectin Cream

SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea....

Sorine- Sotalol Hydrochloride Tablet

1.1 Life-Threatening Ventricular Arrhythmias SORINE (sotalol hydrochloride) tablets are indicated for the treatment of life-threatening, documented ventricular arrhythmias, such as sustained ventricul...

Sotalol Hydrochloride Injection

1.1 Substitution for Oral Sotalol Therapy Intravenous sotalol can substitute for oral sotalol in patients who are unable to take sotalol orally. 1.2 Delay in Recurrence of Atrial Fibrillation/At...

Sotalol Hydrochloride Tablet

1.1 Life-Threatening Ventricular Arrhythmias Sotalol is indicated for the treatment of life-threatening, documented ventricular arrhythmias, such as sustained ventricular tachycardia (VT). Limitatio...

Sotalol Hydrochloride- Sotalol Hydrochloride Tablet

Sotalol is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. Because of the proa...

Sotalol- Sotalol Hydrochloride Tablet

1.1 Life-Threatening Ventricular Arrhythmias Sotalol Hydrochloride Tablets are indicated for the treatment of life-threatening, documented ventricular arrhythmias, such as sustained ventricular tachyc...

Sotalol- Sotalol Tablet

Sotalol hydrochloride tablets (AF) are indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic ...

Sovaldi Access- Sofosbuvir Tablet, Film Coated

Adult Patients: SOVALDI is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) infection as a component of a combination antiviral treatment regimen SOVALDI is...

Sovaldi- Sofosbuvir Tablet, Film Coatedsovaldi- Sofosbuvir Pellet

Adult Patients: SOVALDI is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) infection as a component of a combination antiviral treatment regimen [see Dosage and Admi...

Spherusol- Coccidioides Immitis Spherule-derived Skin Test Antigen Injection, Solution

Spherusol is a skin test antigen indicated for the detection of delayed-type hypersensitivity to Coccidioides immitis in individuals with a history of pulmonary coccidioido...

Spinraza- Nusinersen Injection, Solution

SPINRAZA is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients....

Standardized Cat Hair Allergenic Extract- Felis Catus Solution

GREER Standardized Cat Hair Allergenic Extract is indicated for: Skin test diagnosis of patients with a history of allergy to cats. Treatment of cat hair-induced allergic asthma, rhinitis and conjunc...

Standardized Cat Hair Injection, Solution

Standardized Cat Hair is intended for use in the diagnosis and therapy of cat allergy patients as established by allergy history and skin test reactivity....

Standardized Cat Hair- Cat Hair Injection

Studies have shown that skin tests with cat extract are useful in the diagnosis of cat allergy. As a rule, persons with cat allergy have positive skin reactions when tested with cat extract, and non-a...

Standardized Cat Hair- Felis Domesticus Hair Injection, Solution

Standardized Cat Hair Extracts are indicated for the diagnosis of patients with a history of allergy to cats and for treatment of patients with cat allergy. Diagnosis of allergic disease to cat hair i...

Stelara- Ustekinumab Injection, Solutionstelara- Ustekinumab Solution

1.1 Psoriasis (Ps) STELARA is indicated for the treatment of patients 12 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. 1.2 Pso...

Sterile Vancomycin Hydrochloride- Vancomycin Hydrochloride Injection, Powder, Lyophilized, For Solution

Vancomycin is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci. It is indicated for penicillin-a...

Strensiq- Asfotase Alfa Solution

STRENSIQ is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP)....

Stribild Access- Elvitegravir, Cobicistat, Emtricitabine, And Tenofovir Disoproxil Fumarate Tablet, Film Coated

STRIBILD is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older weighing at least 35 kg who have no antiretroviral treatm...

Stribild- Elvitegravir, Cobicistat, Emtricitabine, And Tenofovir Disoproxil Fumarate Tablet, Film Coated

STRIBILD is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older weighing at least 35 kg who have no antiretroviral treatme...

Stromectol- Ivermectin Tablet

STROMECTOL is indicated for the treatment of the following infections: Strongyloidiasis of the intestinal tract. STROMECTOL is indicated for the treatment of intestinal (i.e., nondisseminated) strong...

Succinylcholine Chloride Injection, Solution

Succinylcholine chloride is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation....

Sucraid- Sacrosidase Solution

Sucraid (sacrosidase) Oral Solution is indicated as oral replacement therapy of the genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID)....

Sucralfate Suspension

Sucralfate Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer....

Sucralfate Tablet

Sucralfate tablets, USP are indicated in: Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be cont...

Sulfamethox-tmp Ds- Sulfamethoxazole, Trimethoprim Tablet

To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablet...

Sulfamethoxazole And Trimethoprim Double Strength- Sulfamethoxazole And Trimethoprim Tablet

To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim t...

Sulfamethoxazole And Trimethoprim Ds Tablet

To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tabl...

Sulfamethoxazole And Trimethoprim Injection

1.1 Pneumocystis jirovecii Pneumonia Sulfamethoxazole and trimethoprim injection is indicated in the treatment of Pneumocystis jirovecii pneumonia in adults and pediatric patients two months of age ...

Sulfamethoxazole And Trimethoprim Injection, Solution, Concentrate

1.1 Pneumocystis jirovecii Pneumonia Limitation of Use: Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe...

Sulfamethoxazole And Trimethoprim Suspension

To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension, USP and other antibacterial drugs, sulfamethoxazole and trimet...

Sulfamethoxazole And Trimethoprim- Sulfamethoxazole And Trimethoprim Tablet

To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablet...

Sulfamylon- Mafenide Acetate Cream

SULFAMYLON Cream is a topical agent indicated for adjunctive therapy of patients with second- and third-degree burns....

Sulfamylon- Mafenide Acetate Powder, For Solution

SULFAMYLON for 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised ...

Supprelin La- Histrelin Acetate Implant

SUPPRELIN LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP). Children with CPP (neurogenic or idiopathic) have an early onse...

Survanta- Beractant Suspension

SURVANTA is indicated for prevention and treatment ( rescue ) of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants. SURVANTA significantly reduces the incidence o...

Sylatron- Peginterferon Alfa-2b Kit

SYLATRON is an alpha interferon indicated for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymph...

Sylvant- Siltuximab Injection, Powder, For Solution

SYLVANT is indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. Limitatio...

Sylvant- Siltuximab Injection, Powder, Lyophilized, For Solution

SYLVANT is indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. Limitatio...

Symdeko- Tezacaftor And Ivacaftor Kit

SYMDEKO is indicated for the treatment of patients with cystic fibrosis (CF) age 6 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis ...

Symlinpen- Pramlintide Acetate Injection

SYMLIN is indicated as an adjunctive treatment in patients with type 1 or type 2 diabetes who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insuli...

Synagis- Palivizumab Injection, Solution

1 INDICATIONS AND USAGE Synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients: with a history of pre...

Synarel- Nafarelin Acetate Spray, Metered

(For Endometriosis, See Reverse Side) SYNAREL is indicated for treatment of central precocious puberty (CPP) (gonadotropin-dependent precocious puberty) in children of both sexes. The diagnosis of cen...

Syndros- Dronabinol Solution

SYNDROS is indicated in adults for the treatment of: anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS). nausea and vomiting associated with cancer chemo...

Synercid- Quinupristin And Dalfopristin Injection, Powder, Lyophilized, For Solution

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Synercid and other antibacterial drugs, Synercid should be used only to treat or prevent infections that are prov...

Synjardy Xr- Empagliflozin, Metformin Hydrochloride Tablet, Extended Release

SYNJARDY XR is a combination of empagliflozin and metformin hydrochloride indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatmen...

Synjardy- Empagliflozin And Metformin Hydrochloride Tablet

SYNJARDY is a combination of empagliflozin and metformin hydrochloride indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment w...

Syprine- Trientine Hydrochloride Capsule

Syprine is indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with Syprine is limited and alternate dosing regimens have not been wel...

T

T.r.u.e. Test Thin-layer Rapid Use Patch Test- Standardized Allergenic Kit

T.R.U.E. TEST is an epicutaneous patch test indicated for use as an aid in the diagnosis of allergic contact dermatitis (ACD) in persons 6 years of age and older whose history suggests sensitivity t...

Tachosil- Thrombin Human And Fibrinogen Patch

TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery when control of bleeding ...

Tafinlar- Dabrafenib Capsule

1.1 BRAF V600E Mutation-Positive Unresectable or Metastatic Melanoma TAFINLAR is indicated as a single agent for the treatment of patients with unresectable or metastati...

Taltz- Ixekizumab Injection, Solution

1.1 Plaque Psoriasis TALTZ is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 1.2 Psoriatic Arthritis TA...

Talzenna- Talazoparib Capsule

TALZENNA is indicated for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated (gBRCAm) human epidermal growth factor rec...

Tamiflu- Oseltamivir Phosphate Powder, For Suspension

1.1 Treatment of Influenza TAMIFLU is indicated for the treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older who have been symptomatic for no more than 2 da...

Tamiflu- Oseltamivir Phosphate Powder, For Suspensiontamiflu- Oseltamivir Phosphate Capsule

1.1 Treatment of Influenza TAMIFLU is indicated for the treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older who have been symptomatic for no more than 2 da...

Tanzeum- Albiglutide Injection, Powder, Lyophilized, For Solution

TANZEUM is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14)]. Limitations of Use: TANZEUM is not recomme...

Tdvax- Tetanus And Diphtheria Toxoids Adsorbed Injection

MassBiologics' TDVAX is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria. This vaccine is approved for use in persons 7 years of age and older....

Tecentriq- Atezolizumab Injection, Solution

1.1 Urothelial Carcinoma TECENTRIQ is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who: are not eligible for cisplatin-containing chemotherap...

Technivie- Ombitasvir And Paritaprevir And Ritonavir Kit

TECHNIVIE is indicated in combination with ribavirin for the treatment of patients with genotype 4 chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis [see Clinic...

Tegsedi- Inotersen Injection, Solution

TEGSEDI is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults....

Tekturna Hct- Aliskiren Hemifumarate And Hydrochlorothiazide Tablet, Film Coatedtekturna Hct- Aliskiren Hemifumarate And Hydrochlorothiazide Tablet, Film Coated

Tekturna HCT is indicated for the treatment of hypertension. Add-On Therapy A patient whose blood pressure is not adequately controlled with aliskiren alone or hydrochlorothiazide alone may be switch...

Tekturna Hct- Aliskiren Hemifumarate And Hydrochlorothiazide Tablet, Film Coated

Tekturna HCT is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myoca...

Tekturna- Aliskiren Hemifumarate Tablet, Film Coated

1.1 Hypertension Tekturna is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily st...

Tenivac (clostridium Tetani Toxoid Antigen (formaldehyde Inactivated) And Corynebacterium Diphtheriae Toxoid Antigen- Formaldehyde Inactivated Injection, Suspension

TENIVAC is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older....

Teriflunomide Tablet, Film Coated

Teriflunomide tablet is indicated for the treatment of patients with relapsing forms of multiple sclerosis....

Tetrabenazine Tablet

Tetrabenazine tablets are indicated for the treatment of chorea associated with Huntington's disease....

Tetrabenazine Tablet, Coated

Tetrabenazine tablets are indicated for the treatment of chorea associated with Huntington's disease....

Thalomid- Thalidomide Capsule

1.1 Multiple Myeloma THALOMID in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM) [see Clinical Studies (14.1)]. 1.2 Erythema...

Thiola Ec- Tiopronin Tablet, Delayed Release

THIOLA EC is indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with seve...

Thiola- Tiopronin Tablet, Sugar Coated

THIOLA is indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe ...

Thymoglobulin (anti-thymocyte Globulin- Rabbit Injection, Powder, Lyophilized, For Solution

THYMOGLOBULIN is indicated for the prophylaxis and treatment of acute rejection in patients receiving a kidney transplant. THYMOGLOBULIN is to be used in conjunction with concomitant immunosuppressio...

Thyrogen- Thyrotropin Alfa Injection, Powder, For Solutionthyrogen- Thyrotropin Alfa Kit

1.1 Adjunctive Diagnostic Tool for Serum Thyroglobulin Testing in Well Differentiated Thyroid Cancer THYROGEN is indicated for use as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testi...

Ticagrelor Tablet

Ticagrelor tablets are indicated to reduce the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction (MI)...

Tice Bcg- Bacillus Calmette-guerin Powder, For Suspension

TICE BCG is indicated for: the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following tran...

Tigecycline Injection, Powder, Lyophilized, For Solution

1.1 Complicated Skin and Skin Structure Infections Tigecycline for injection is indicated in patients 18 years of age and older for the treatment of complicated skin and skin structure infections cau...

Tiglutik- Riluzole Liquid

TIGLUTIK is indicated for the treatment of amyotrophic lateral sclerosis (ALS)....

Tivicay- Dolutegravir Sodium Tablet, Film Coated

TIVICAY is indicated in combination with: other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients weighing at le...

Tolvaptan Tablet

Tolvaptan tablets are indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has ...

Trace Elements 4 Injection, Solution

This formulation is indicated for use as a supplement to intravenous solutions given for TPN for children up to 11 years of age. Administration of the solution in TPN solutions helps to maintain plasm...

Treatment Set Ts332256 Injection, Solutiontreatment Set Ts331153 Injection, Solutiontreatment Set Ts329151 Injection, Solutiontreatment Set Ts329152 Injection, Solutiontreatment Set Ts332147 Injection, Solutiontreatment Set Ts330836 Injection, Solutiontreatment Set Ts331634 Injec ......., Solutiontreatment Set Ts332678 Injection, Solutiontreatment Set Ts332679 Injection, Solutiontreatment Set Ts331795 Injection, Solutiontreatment Set Ts331796 Injection, Solutiontreatment Set Ts329413 Injection, Solutiontreatment Set Ts334696 Injection, Solution

When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to...

Treatment Set Ts334946 Injection, Solutiontreatment Set Ts334947 Injection, Solution

When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to...

Treatment Set Ts335061 Injection, Solutiontreatment Set Ts335100 Injection, Solutiontreatment Set Ts335101 Injection, Solution

When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to...

Treatment Set Ts335657 Injection, Solutiontreatment Set Ts335683 Injection, Solution

When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to...

Treatment Set Ts335823 Injection, Solutiontreatment Set Ts335861 Injection, Solution

When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to...

Treatment Set Ts336667 Injection, Solutiontreatment Set Ts336682 Injection, Solutiontreatment Set Ts336683 Injection, Solution

When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to...

Treatment Set Ts336924 Injection, Solutiontreatment Set Ts336312 Injection, Solution

When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to...

Treatment Set Ts337026 Injection, Solutiontreatment Set Ts336851 Injection, Solution

When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to...

Treatment Set Ts337554 Injection, Solutiontreatment Set Ts337681 Injection, Solutiontreatment Set Ts338384 Injection, Solution

When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to...

Treatment Set Ts338618 Injection, Solutiontreatment Set Ts338909 Injection, Solutiontreatment Set Ts338910 Injection, Solutiontreatment Set Ts339118 Injection, Solutiontreatment Set Ts339119 Injection, Solution

When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to...

Treatment Set Ts339184 Injection, Solutiontreatment Set Ts339185 Injection, Solution

When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to...

Treatment Set Ts339754 Injection, Solutiontreatment Set Ts340054 Injection, Solutiontreatment Set Ts339813 Injection, Solutiontreatment Set Ts339992 Injection, Solutiontreatment Set Ts340053 Injection, Solution

When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to...

Treatment Set Ts340074 Injection, Solutiontreatment Set Ts340153 Injection, Solutiontreatment Set Ts340525 Injection, Solutiontreatment Set Ts340526 Injection, Solution

When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to...

Treatment Set Ts340796 Injection, Solutiontreatment Set Ts340826 Injection, Solution

When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to...

Trelstar- Triptorelin Pamoate Kit

TRELSTAR is indicated for the palliative treatment of advanced prostate cancer [see Clinical Studies (14)]....

Tremfya- Guselkumab Injection

TREMFYA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy....

Treprostinil Injection, Solution

1.1 Pulmonary Arterial Hypertension Treprostinil Injection is indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies e...

Treprostinil Injectiondiluent- Water Solution Injection

1.1 Pulmonary Arterial Hypertension Treprostinil injection is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group 1) to diminish symptoms associated with exercise. Studies e...

Treprostinil Solution

1.1 Pulmonary Arterial Hypertension 1.2 Pulmonary Arterial Hypertension in Patients Requiring Transition from Epoprostenol...

Tretten (coagulation Factor Xiii A-subunit- Recombinant Kit

TRETTEN, Coagulation Factor XIII A-Subunit (Recombinant), is indicated for routine prophylaxis for bleeding in patients with congenital factor XIII A-subunit deficiency. TRETTEN is not for use in pat...

Triamterene And Hydrochlorothiazide- Hydrochlorothiazide And Triamterene Capsule

This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. Triamterene and hydrochloro...

Triamterene And Hydrochlorothiazide- Triamterene And Hydrochlorothiazide Tablet

This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. Triamterene and Hydrochlor...

Triamterene- Triamterene Capsules Capsule

Triamterene Capsules USP is indicated in the treatment of edema associated with congestive heart failure, cirrhosis of the liver and the nephrotic syndrome; steroid-induced edema, idiopathic edema and...

Trientine Hydrochloride Capsule

Trientine hydrochloride capsules USP 250 mg is indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with trientine hydrochloride capsul...

Trientine Hydrochloride- Trientine Capsule, Gelatin Coated

Trientine HCl capsules are indicated in the treatment of patients with Wilson s disease who are intolerant of penicillamine. Clinical experience with trientine HCl capsules is limited and alternate ...

Trikafta- Elexacaftor, Tezacaftor, And Ivacaftor Kit

TRIKAFTA is indicated for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (C...

Triptodur- Triptorelin Kit

TRIPTODUR is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP)....

Triumeq- Abacavir Sulfate, Dolutegravir Sodium, Lamivudine Tablet, Film Coated

TRIUMEQ is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients weighing at least 40 kg. Limitations of Use: TRIUMEQ alone is n...

Trulance Immediate Release- Plecanatide Tablet

TRULANCE is indicated in adults for the treatment of: chronic idiopathic constipation (CIC). irritable bowel syndrome with constipation (IBS-C)...

Trulicity- Dulaglutide Injection, Solution

TRULICITY is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 1.1 Limitations of Use TRULICITY is not recommended as...

Truxima- Rituximab-abbs Injection, Solution

1.1 Non Hodgkin's Lymphoma (NHL) TRUXIMA (rituximab-abbs) is indicated for the treatment of adult patients with: Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a sing...

Tubersol- Tuberculin Purified Protein Derivative Injection, Solution

TUBERSOL, Tuberculin Purified Protein Derivative (Mantoux), is indicated to aid diagnosis of tuberculosis infection (TB) in persons at increased risk of developing active disease. The Centers for Dise...

Twinrix (hepatitis A And Hepatitis B- Recombinant Vaccine Injection, Suspension

TWINRIX is indicated for active immunization against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus. TWINRIX is approved for use in persons 18 years of...

Tygacil- Tigecycline Injection, Powder, Lyophilized, For Solution

1.1 Complicated Skin and Skin Structure Infections Tigecycline for injection is indicated in patients 18 years of age and older for the treatment of complicated skin and skin structure infections cau...

Tymlos- Abaloparatide Injection, Solution

TYMLOS is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients...

Typhim Vi- Salmonella Typhi Ty2 Vi Polysaccharide Antigen Injection, Solution

Typhim Vi vaccine is indicated for active immunization for the prevention of typhoid fever caused by S typhi and is approved for use in persons two years of age or older. Immunization with Typhim Vi ...

Tysabri- Natalizumab Injection

1.1. Multiple Sclerosis (MS) TYSABRI is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and ...

Tyvaso- Treprostinil Inhalant

Tyvaso is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA F...

U

Udenyca- Pegfilgrastim-cbqv Injection, Solution

UDENYCA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated wit...

Ultomiris- Ravulizumab Solution, Concentrate

ULTOMIRIS is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH)....

Ultramicrosize Griseofulvin- Ultramicrosize Griseofulvin Tablets Tablet, Coated

Ultramicrosize griseofulvin tablets are indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of...

Unituxin- Dinutuximab Injection

Unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of pediatric p...

Uptravi- Selexipag Tablet, Coateduptravi Titration Pack- Selexipag Kit

1.1 Pulmonary Arterial Hypertension UPTRAVI is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for...

Urelle- Hyoscyamine Sulfate, Methenamine, Methylene Blue, Phenyl Salicylate, And Sodium Phosphate, Monobasic, Monohydrate Tablet

Urelle is indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary trac...

Uribel- Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate Capsule

Uribel capsules indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, a...

Urimar-t- Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate Tablet

URIMAR-T is indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary t...

Urin D/s- Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate Tablet

Indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections...

Urised- Methenamine, Phenyl Salicylate, Methylene Blue, Benzoic Acid, Atropine Sulfate , Hyoscyamine Tablet

U R I S E D is indicated for the relief of discomfort of the lower urinary tract caused by hypermotility resulting from inflammation or diagnostic procedures and in the treatment of cystitis, ...

Uro-458- Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue And Hyoscyamine Sulfate Tablet

Uro-458 Tablets is indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urin...

Uro-mp- Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue And Hyoscyamine Sulfate Capsule

Uro-MP Capsules are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower uri...

Uroav-81- Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue And Hyoscyamine Sulfate Tablet

UroAv-81 Tablets is indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower uri...

Uroav-b- Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue And Hyoscyamine Sulfate Capsule

UroAv-B Capsules are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower ur...

Uvadex- Methoxsalen Injection, Solution

UVADEX (methoxsalen) Sterile Solution is indicated for extracorporeal administration with the THERAKOS UVAR XTS or THERAKOS CELLEX Photopheresis System in the palliative treatment of the ski...

V

Valcyte- Valganciclovir Tablet, Film Coatedvalcyte- Valganciclovir Hydrochloride Powder, For Solution

1.1 Adult Patients Treatment of Cytomegalovirus (CMV) Retinitis: VALCYTE is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Stud...

Vancocin- Vancomycin Hydrochloride Capsule

VANCOCIN CAPSULES are indicated for the treatment of C. difficile-associated diarrhea. VANCOCIN CAPSULES are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including me...

Vancomycin Hydrochloride Capsule

Vancomycin hydrochloride capsules are indicated for the treatment of C. difficile-associated diarrhea. Vancomycin hydrochloride capsules are also used for the treatment of enterocolitis caused by Stap...

Vancomycin Hydrochloride Injection

Vancomycin hydrochloride for injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant ( -lactam-resistant) staphylococci. I...

Vancomycin Hydrochloride- Vancomycin Hydrochloride Injection, Powder, Lyophilized, For Solutionvancomycin Hydrochloride Injection, Powder, Lyophilized, For Solution

Vancomycin hydrochloride for injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant ( -lactam-resistant) staphylococci. ...

Vancomycin Hydrochloride- Vancomycin Injection, Solution

Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant ( -lactam-resistant) staphylococci. I...

Vancomycin- Vancomycin Hydrochloride Injection, Powder, Lyophilized, For Solution

Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant ( -lactam-resistant) staphylococci. I...

Vaniqa- Eflornithine Hydrochloride Cream

VANIQA (eflornithine hydrochloride) cream, 13.9% is indicated for the reduction of unwanted facial hair in women. VANIQA has only been studied on the face and adjacent involved areas under the c...

Vantas- Histrelin Acetate Implant

VANTAS is indicated for the palliative treatment of advanced prostate cancer....

Vaprisol Dextrose In Plastic Container- Conivaptan Hydrochloride Injection, Solution

VAPRISOL is indicated to raise serum sodium in hospitalized patients with euvolemic and hypervolemic hyponatremia. Limitations of Use: VAPRISOL has not been shown to be effective for the treatmen...

Vaqta- Hepatitis A Vaccine, Inactivated Injection, Suspension

1.1 Indications and Use VAQTA [Hepatitis A Vaccine, Inactivated] is indicated for the prevention of disease caused by hepatitis A virus (HAV) in persons 12 months of age and older. The primary dose ...

Varithena- Polidocanol Kitvarithena Tm- Polidocanol Kit

VARITHENA (polidocanol injectable foam) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein (GSV) syst...

Varivax- Varicella Virus Vaccine Live Injection, Powder, Lyophilized, For Suspension

VARIVAX is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age and older....

Vaxelis (diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus B Conjugate (meningococcal Protein Conjugate) And Hepatitis B- Recombinant Vaccine Injection, Suspension

VAXELIS is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae (H. influenzae) type...

Vecamyl- Mecamylamine Hydrochloride Tablet

For the management of moderately severe to severe essential hypertension and in uncomplicated cases of malignant hypertension....

Vectibix- Panitumumab Solution

1.1 Metastatic Colorectal Cancer Vectibix is indicated for the treatment of patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test...

Velcade- Bortezomib Injection, Powder, Lyophilized, For Solution

1.1 Multiple Myeloma VELCADE is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma VELCADE is indicated for the treatment of adult patients with mantle c...

Veletri- Epoprostenol Injection, Powder, Lyophilized, For Solution

VELETRI is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA...

Veltassa- Patiromer Powder, For Suspension

Veltassa is indicated for the treatment of hyperkalemia. Limitation of Use: Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of act...

Venclexta- Venetoclax Kitvenclexta- Venetoclax Tablet, Film Coated

1.1 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma VENCLEXTA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 1...

Ventavis- Iloprost Solution

1.1 Pulmonary Arterial Hypertension Ventavis is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve a composite endpoint consisting of exercise tolerance, ...

Viadur- Leuprolide Acetate

Viadur is indicated in the palliative treatment of advanced prostate cancer....

Vibativ- Telavancin Hydrochloride Injection, Powder, Lyophilized, For Solution

To reduce the development of drug-resistant bacteria and maintain the effectiveness of VIBATIV and other antibacterial drugs, VIBATIV should be used only to treat infections that are proven or strongl...

Viberzi- Eluxadoline Tablet, Film Coated

VIBERZI is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D)....

Victoza- Liraglutide Injection

VICTOZA is indicated: as an adjunct to diet and exercise to improve glycemic control in patients 10 years and older with type 2 diabetes mellitus, to reduce the risk ...

Viekira Pak- Dasabuvir And Ombitasvir And Paritaprevir And Ritonavir Kit

VIEKIRA PAK is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) [see Dosage and Administration (2.2) and Clinical Studies (14)]: genotype 1b without cirrhosis or wit...

Viekira Xr- Dasabuvir And Ombitasvir And Paritaprevir And Ritonavir Kit

VIEKIRA XR is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) [see Dosage and Administration (2.2) and Clinical Studies (14)]: genotype 1b infection without cirrhos...

Vimizim- Elosulfase Alfa Injection, Solution, Concentrate

Vimizim (elosulfase alfa) is indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome)....

Vinblastine Sulfate Injection

Vinblastine Sulfate Injection is indicated in the palliative treatment of the following: I. Frequently Responsive Malignancies Generalized Hodgkin s disease (Stages III and IV, Ann Arbor modificat...

Vincasar Pfs- Vincristine Sulfate Injection, Solution

VINCASAR PFS is indicated in acute leukemia. VINCASAR PFS has also been shown to be useful in combination with other oncolytic agents in Hodgkin s disease, non-Hodgkin s malignant lymphomas, rhabd...

Vincristine Sulfate Injection, Solution

Vincristine sulfate injection is indicated in acute leukemia. Vincristine sulfate injection has also been shown to be useful in combination with other oncolytic agents in Hodgkin's disease, non Hodg...

Vinorelbine Injection

Vinorelbine injection is indicated: In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) As a single agent f...

Vinorelbine Injection, Solution

Vinorelbine injection is indicated: In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) As a single agent for the...

Visionblue- Trypan Blue Injection, Solution

HIGHLIGHTS OF PRESCRIBING INFORMATION (1) These highlights do not include all the information needed to use VISIONBLUE 0.06% safely and effectively. see full prescribing information for VISIONBLUE ...

Vistogard- Uridine Triacetate Granule

VISTOGARD is indicated for the emergency treatment of adult and pediatric patients: following a fluorouracil or capecitabine overdose regardless of the presence of symptoms, or who exhibit early-o...

Visudyne- Verteporfin For Injection Injection, Powder, Lyophilized, For Solution

VISUDYNE (verteporfin for injection) therapy is indicated for the treatment of patients with predominantly classic subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration ...

Vitrase- Hyaluronidase, Ovine Injection, Solution

1.1 Subcutaneous Fluid Administration (Hypodermoclysis) VITRASE (hyaluronidase injection) Ovine is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration. 1.2 Dispe...

Vivotif- Salmonella Typhi Ty21a Capsule, Coated

Vivotif (Typhoid Vaccine Live Oral Ty21a) is indicated for immunization of adults and children greater than 6 years of age against disease caused by Salmonella typhi. Routine typhoid vaccination is n...

Vonvendi (von Willebrand Factor- Recombinant Kit

VONVENDI [von Willebrand factor (recombinant)] is a recombinant von Willebrand factor (rVWF) indicated for use in adults (age 18 and older) diagnosed with von Willebrand disease (VWD) for: On-demand ...

Voraxaze- Glucarpidase Injection, Powder, For Solution

VORAXAZE is indicated to reduce toxic plasma methotrexate concentration (greater than 1 micromole per liter) in adult and pediatric patients with delayed methotrexate clearance (plasma methotrexate co...

Vosevi- Sofosbuvir, Velpatasvir, And Voxilaprevir Tablet, Film Coated

VOSEVI is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have [see Dosage and Administr...

Vpriv- Velaglucerase Alfa Injection, Powder, Lyophilized, For Solution

VPRIV is indicated for long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease....

W

Warfarin Sodium Tablet

Warfarin sodium tablets, USP are indicated for: Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE). Prophylaxis and treatment of thromboembolic complications as...

Warfarin Sodium- Warfarin Tablet

Warfarin sodium is indicated for: Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE). Prophylaxis and treatment of thromboembolic complications associated w...

Wilate - Von Willebrand Factor/coagulation Factor Viii Complex (human) (von Willebrand Factor/coagulation Factor Viii Complex- Human Powder, For Solution

Wilate is a von Willebrand Factor/Coagulation Factor VIII Complex (Human) indicated for the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe von Willebrand disease...

X

Xadago- Safinamide Mesylate Tablet, Film Coated

XADAGO is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes. Limitations of Use: XADAGO has not been shown to be effective...

Xalkori- Crizotinib Capsule

XALKORI is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved ...

Xarelto- Rivaroxaban Tablet, Film Coated

1.1 Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation XARELTO is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fib...

Xarelto- Rivaroxaban Tablet, Film Coatedxarelto- Rivaroxaban Tablet, Film Coatedxarelto- Rivaroxaban Kit

1.1 Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation XARELTO is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fib...

Xeljanz- Tofacitinib Tablet, Film Coatedxeljanz Xr- Tofacitinib Tablet, Extended Release

Rheumatoid Arthritis XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to m...

Xeljanz- Tofacitinib Tablet, Film Coatedxeljanz Xr- Tofacitinib Tablet, Film Coated, Extended Release

Rheumatoid Arthritis XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance...

Xenazine- Tetrabenazine Tablet

XENAZINE is indicated for the treatment of chorea associated with Huntington's disease....

Xenical- Orlistat Capsule

XENICAL is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. XENICAL is also indicated to reduce the risk for weight r...

Xenon, Xe-133- Xenon Gas

Xenon Xe 133 Gas has been shown to be valuable for diagnostic inhalation studies for the evaluation of pulmonary function, for imaging the lungs and may also be applied to assessment of cerebral blood...

Xenon- Xenon Xe-133 Gas

Inhalation of Xenon Xe 133 Gas has proved valuable for the evaluation of pulmonary function and for imaging the lungs. It may also be applied to assessment of cerebral flow....

Xeomin- Incobotulinumtoxina Injection, Powder, Lyophilized, For Solution

1.1 Chronic Sialorrhea XEOMIN is indicated for the treatment of chronic sialorrhea in adult patients. 1.2 Upper Limb Spasticity XEOMIN is indicated for the treatment of upper limb spasticity in adu...

Xermelo- Telotristat Ethyl Tablet

Xermelo is indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy....

Xgeva- Denosumab Injection

1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Xgeva is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone me...

Xiaflex- Collagenase Clostridium Histolyticum Kit

XIAFLEX is indicated for the treatment of adult patients with Dupuytren s contracture with a palpable cord. XIAFLEX is indicated for the treatment of adult men with Peyronie s disease with a palpa...

Xigduo Xr- Dapagliflozin And Metformin Hydrochloride Tablet, Film Coated, Extended Release

XIGDUO XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin is indicated to reduce the risk of hospitalization for hear...

Xiidra- Lifitegrast Solution/ Drops

Xiidra (lifitegrast ophthalmic solution) 5% is indicated for the treatment of the signs and symptoms of dry eye disease (DED)....

Xofigo- Radium Ra 223 Dichloride Injection

Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease....

Xofluza- Baloxavir Marboxil Tablet, Film Coated

XOFLUZA is indicated for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours. Limitations of Use: Influenza vi...

Xolair- Omalizumab Injection, Solutionxolair Pfs- Omalizumab Injection, Solution

1.1 Asthma XOLAIR is indicated for patients 6 years of age and older with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whos...

Xultophy 100/3.6 (- Insulin Degludec And Liraglutide Injection, Solution

XULTOPHY 100/3.6 is a combination of insulin degludec and liraglutide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitati...

Xuriden- Uridine Triacetate Granule

XURIDEN is indicated for the treatment of hereditary orotic aciduria....

Xyrem- Sodium Oxybate Solution

Xyrem is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy....

Y

Yervoy- Ipilimumab Injection

1.1 Unresectable or Metastatic Melanoma YERVOY is indicated for the treatment of unresectable or metastatic melanoma in adults and pediatric patients (12 years and older) [see Clinical Studies (14.1)...

Yf-vax- Yellow Fever Virus Strain 17d-204 Live Antigen Injection, Powder, Lyophilized, For Suspensiondiluent- Sodium Chloride Injection

YF-VAX is indicated for active immunization for the prevention of yellow fever in persons 9 months of age and older in the following categories: Persons Living in or Traveling to Endemic Areas While...

Yonsa- Abiraterone Acetate Tablet

YONSA is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer....

Z

Zaleplon Capsule

Zaleplon is indicated for the short-term treatment of insomnia. Zaleplon has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under...

Zaleplon- Zaleplon Capsule

Zaleplon is indicated for the short-term treatment of insomnia. Zaleplon has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under...

Zaltrap- Ziv-aflibercept Solution, Concentrate

ZALTRAP, in combination with 5-fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an ox...

Zarxio- Filgrastim-sndz Injection, Solution

1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy ZARXIO is indicated to decrease the incidence of infection as manifested by febrile neutropenia in patients with nonmyeloid malig...

Zavesca- Miglustat Capsule

1.1 Type 1 Gaucher Disease Zavesca is a glucosylceramide synthase inhibitor indicated as monotherapy for the treatment of adult patients with mild to moderate type 1 Gaucher disease for whom enzyme r...

Zejula- Niraparib Capsule

ZEJULA is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to plati...

Zelapar- Selegiline Hydrochloride Tablet, Orally Disintegrating

ZELAPAR is indicated as an adjunct in the management of patients with Parkinson s disease being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this the...

Zelnorm- Tegaserod Tablet

ZELNORM is indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C). Limitations of Use The safety and effectiveness of ZELNORM in...

Zemaira- Alpha-1-proteinase Inhibitor Human Kitzemaira- .alpha.1-proteinase Inhibitor Human Kit

ZEMAIRA is an alpha1-proteinase inhibitor (A1-PI) indicated for chronic augmentation and maintenance therapy in adults with A1-PI deficiency and clinical evidence of emphysema. ZEMAIRA increases antig...

Zepatier- Elbasvir And Grazoprevir Tablet, Film Coated

ZEPATIER is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 infection in adults. ZEPATIER is indicated for use with ribavirin in certain patient populations [see Dosag...

Zevalin- Ibritumomab Tiuxetan Kit

1.1 Relapsed or Refractory, Low-grade or Follicular NHL Zevalin is indicated for the treatment of adult patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (...

Zileuton Tablet, Extended Release

Zileuton Extended-Release Tablets is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. Zileuton Extended-Release Tablets is not indicated...

Zinbryta Pen- Daclizumab Injection, Solutionzinbryta- Daclizumab Injection, Solution

ZINBRYTA is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of ZINBRYTA should generally be reserved for patients ...

Zioptan- Tafluprost Solution/ Drops

ZIOPTAN (tafluprost ophthalmic solution) 0.0015% is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension....

Zoladex- Goserelin Acetate Implant

1.1 Stage B2-C Prostatic Carcinoma ZOLADEX is indicated for use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate. Treatment with...

Zolinza- Vorinostat Capsule

ZOLINZA is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic thera...

Zomacton- Somatropin Kit

1.1 Pediatric Patients ZOMACTON is indicated for the treatment of pediatric patients with: growth failure due to inadequate secretion of endogenous growth hormone (GH), short stature associated with ...

Zontivity- Vorapaxar Tablet, Film Coated

1.1 Patients with History of Myocardial Infarction (MI) or with Peripheral Arterial Disease (PAD) ZONTIVITY is indicated for the reduction of thrombotic cardiovascular events in patients with a ...

Zorbtive- Somatropin Kit

Zorbtive is indicated for the treatment of short bowel syndrome in adult patients receiving specialized nutritional support....

Zortress- Everolimus Tablet

1.1 Prophylaxis of Organ Rejection in Kidney Transplantation Zortress is indicated for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a ...

Zostavax- Zoster Vaccine Live Injection, Powder, Lyophilized, For Suspensionsterile Diluent- Sterile Water Injection

ZOSTAVAX is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older. Limitations of Use of ZOSTAVAX: ZOSTAVAX is not indicated ...

Zurampic- Lesinurad Tablet, Film Coated

ZURAMPIC is indicated in combination with a xanthine oxidase inhibitor for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a xa...

Zyclara- Imiquimod Cream

1.1 Actinic Keratosis ZYCLARA Cream, 2.5% and 3.75% are indicated for the topical treatment of clinically typical visible or palpable, actinic keratoses (AK) of the full face or balding scalp in immun...

Zyflo Cr- Zileuton Tablet, Multilayer, Extended Release

ZYFLO CR is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. ZYFLO CR is not indicated for use in the reversal of bronchospasm in acute a...

Zyflo- Zileuton Tablet

ZYFLO is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older....

Zykadia- Ceritinib Capsulezykadia- Ceritinib Tablet, Film Coated

ZYKADIA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved ...

Zytiga- Abiraterone Acetate Tabletzytiga- Abiraterone Acetate Tablet, Film Coated

ZYTIGA is indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer ...



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