Warnings ⮝
The only approved method for determining hypersensitivity to Allermed Laboratories Allergenic Extracts is by diagnostic skin testing (See DOSAGE AND ADMINISTRATION DIAGNOSIS).
Physicians who administer allergenic extract should have emergency medication and equipment available to treat anaphylaxis 14. See Precautions, Adverse Reactions and Overdosage below.
To reduce the risk of anaphylaxis, the following measures must be observed:
- Concentrated extract must be diluted before use for intradermal skin testing and for beginning immunotherapy. It should never be injected intravenously during testing or treatment procedures.
- Patients who are highly sensitive, determined from clinical findings and test results, may require that treatment start with a very weak concentration of extract, such as 1:10,000,000 v/v.
- The dosage of fresh (new) extract given to a patient receiving maintenance injections must be reduced to one-fourth the amount given from the previous (old) lot (See Immunotherapy, last paragraph).
- Patients who are transferred to standardized extract after previous treatment with unstandardized extract must be skin tested with serial dilutions, starting with a 1:100,000 v/v dilution of the standardized extract, to determine a safe, non-reacting starting dose.
- Patients who are transferred to this extract after treatment with alum precipitated or other modified extract must re-start injections with the beginning recommended dose of this extract.
Description ⮝
Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.
Clinical Pharmacology ⮝
Positive skin tests with allergenic extract are the result of histamine release from mast cells sensitized with allergen specific IgE. The exact mechanisms by which immunotherapy relieves symptoms of allergy are still under investigation. Elevations in allergen-specific IgG antibodies and an increase in the activity of T suppressor lymphocytes appear to be some of the immunologic changes that occur from hyposensitization. 1,2,3
Indications And Usage ⮝
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 conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. 4,5,6
Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. 7-12
Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.
Contraindications ⮝
Allergenic extract should not be administered to a non-allergic person. However, there are no absolute contraindications to the use of allergenic extract for treatment in appropriate individuals. Relative contraindications include: EXTREME SENSITIVITY TO AN ALLERGEN - Determined from the allergic history, or from previous anaphylaxis following skin testing or subcutaneous injection; AUTOIMMUNE DISEASE - Individuals with autoimmune disease may be at risk, due to the possibility of routine immunizations exacerbating symptoms of the underlying disease; PREGNANCY - In limited controlled studies of women receiving allergenic extract during conception and throughout all trimesters of pregnancy, no evidence was found that extract is harmful to the fetus or mother. However, because of the known pharmacologic action of histamine on uterine muscle, any treatment that might result in the release of significant amounts of this mediator should be avoided if possible 13. See Precaution #4; MYOCARDIAL INFARCTION - Patients who have experienced a recent myocardial infarction may not be able to tolerate immunotherapy. As in all of the above circumstances, the benefit to risk ration must be carefully evaluated; BLEEDING DIATHESIS - Patients with a bleeding tendency should not be tested or treated with allergenic extract, unless the physician responsible believes that such procedures are safe to perform.
Allergenic extract should be temporarily withheld from patients if any of the following conditions exist: (1) severe symptoms of hay fever and/or asthma; (2) infection or flu accompanied by fever; and (3) exposure to excessive amounts of clinically relevant allergens prior to skin testing or immunotherapy.
Precautions ⮝
- Extract should be stored at 2 C to 8 C since higher temperatures may adversely affect the stability of the product. Do not freeze.
- After the needle is inserted subcutaneously, the plunger should be withdrawn slightly to check for the presence of blood in the syringe. If blood is observed, a new injection should be prepared and given at another site, observing the same precautions.
- Treatment with beta-blocking drugs may make patients refractory to the usual dose of epinephrine, in the event epinephrine is required to control an adverse allergic reaction.
- PREGNANCY CATEGORY C. Allergenic extract. Animal reproduction studies have not been conducted with allergenic extract. It is also not known whether allergenic extract can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Allergenic extract should be given to a pregnant woman only if clearly needed.
- PATIENT INSTRUCTIONS: Patients should be instructed to remain in the physician's office for at least 20 minutes after skin testing and after each treatment injection, and immediately notify the physician if symptoms of a generalized reaction or shock occur.
- CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: Long term studies have not been conducted with allergenic extracts to determine their potential for carcinogenesis, mutagenesis, and impairment of fertility.
- LACTATION: Data are not available on the secretion of allergenic extract in human milk and it is not known what affect this might have on the nursing infant.
- PEDIATRIC USE: The dose of allergenic extract recommended for children is the same as that used for adults, except in the injection of large doses of extract for treatment. In this case, the amount of extract given to a child may be modified so that the discomfort of the injection is minimized.
Adverse Reactions ⮝
Local Reactions: The occurrence of a hive 5 to 15 minutes after the subcutaneous injection of extract does not require a reduction in dosage. However, a local reaction with edema larger than 2 cm in diameter or swelling and redness that persist for several hours or longer indicates that too much extract has been given. Treatment should be altered as follows:
- Additional injections should not be given until all evidence of the reaction has disappeared.
- The next injection administered should be 50% of the last non-reacting dose or less, depending upon the size and severity of the local reaction.
- Subsequent injections should be continued at the reduced dosage unless the physician responsible for treatment believes that it is safe to increase the dose, and that possible clinical improvement would result form the administration of a larger dose of extract.
Systemic Reactions:Systemic (generalized) reactions may range from a mild exacerbation of the patient's allergic symptoms to hives, anaphylactic shock, or even death from anaphylaxis. The reaction usually occurs 5 to 20 minutes after injection. As a rule, the more quickly a reaction develops, the more serious it is likely to become. Symptoms may include sneezing, coughing, itching, shortness of breath, abdominal cramps, vomiting, diarrhea, tachycardia, hypotension and respiratory failure in severe cases. The reaction is usually stopped by the subcutaneous injection of Epinephrine HCL 1:1,000 (See Overdosage below). The oral administration of antihistamines and the placement of a tourniquet proximal to the injection site are helpful adjuncts. In the event that additional measures are required, it may be necessary to treat the patient for BRONCHOSPASM with intravenous aminophylline, intravenous fluids and corticosteroids; for HYPOTENSION with vasopressors, volume repletion, isoproterenol and corticosteroids; for LARYNGEAL OBSTRUCTION with oxygen and tracheostomy and for CARDIAC ARREST with cardiopulmonary resuscitation and other appropriate measures.
Immunotherapy after anaphylaxis should be continued if the cause of the reaction can be identified and appropriate precautions taken to insure that a subsequent reaction does not occur.
Overdosage ⮝
A strong local reaction to the injection of extract may be treated with oral antihistamines and the local application of a cold compress. The dosage must be reduced and additional extract must not be given until all evidence of the reaction has disappeared.
A systemic reaction following the injection of extract must be treated immediately. Reported procedures include (Ref. #4, vol. 2, p. 888):
- 0.01 mL/kg up to 0.2 mL of aqueous epinephrine HCL 1:1000 subcutaneously at the injection site of antigen.
- 0.01 mL/kg up to 0.3 mL of aqueous epinephrine HCL 1:1000 subcutaneously at another site.
- Diphenhydramine intravenously or intramuscularly, 1.25 mg/kg up to 50 mg.
- Tourniquet above the injection site of antigen.
Specific reactions:
- Brochospasm: intravenous aminophylline 4 mg/kg up to 500 mg given over 10 to 15 minutes, aqueous hydrocortisone 5 mg/kg up to 200 mg, oxygen.
- Laryngeal edema: oxygen, intubation, tracheostomy.
- Hypotension: vasopressors, fluids, corticosteroids.
- Cardiac arrest: resuscitation, sodium bicarbonate, defibrillation, antiarrhythmia medications.
Dosage And Administration ⮝
Diagnosis: Concentrated extract may be used for scratch or prick testing providing the patient is not extremely sensitive. In this case, the extract should be diluted 10 fold before a scratch or prick test is performed. Extract for intradermal testing must be used as follows:
a. Patients with a negative scratch or prick test: Patients who do not react who do not react to a valid scratch or prick test should be tested intradermally with 0.05 mL of a 1:1000 v/v dilution of the concentrate. If the test is negative, a second test should be performed with 0.05 mL of a 1:100 v/v dilution or concentrate.
b. Patients with positive scratch or prick tests: It is not advisable to perform an intradermal skin test if the patient has a positive scratch or prick test.
c. Patients tested only by the intradermal method: Patients suspected of being highly allergic should be tested with 0.05 mL of a 1:100,000 v/v dilution of the concentrate. A negative test should be followed by repeat tests using 10 fold stronger concentrations until the maximum dose of 0.05 mL of a 1:100 v/v dilution is reached.
Interpretation of Results
Scratch and Prick Test
A negative test shows only a slight red area at the site of scarification or prick penetration. Positive tests are scored as follows:
1+ Erythema with 5 mm wheal
2+ Erythema with a 5-10 mm wheal
3+ Erythema with a 10-15 mm wheal
4+ Erythema with a wheal 15 mm (or larger) with pseudopodia
Intradermal Test
A negative test shows no change in the appearance and size of the 5 mm wheal created by the I.D. injection of 0.05 mL of extract. Positive tests are scored as follows:
1+ Erythema 10-20 mm with a 5-10 mm wheal
2+ Erythema 20-30 mm with a 5-10 mm wheal
3+ Erythema 30-40 mm with a 10-15 mm wheal
4+ Erythema greater than 40 mm with a 15 mm wheal (or larger) with pseudopodia
Immunotherapy
Allergenic extract should be administered subcutaneously in the outer aspect of the upper arm using a sterile tuberculin syringe and needle. The skin should be cleaned with 70% alcohol and aseptic technique should be observed in removing the extract from the vial. Care must be taken to avoid injecting the extract into a blood vessel because of the risk of anaphylaxis.
Concentrated extract must be diluted before administration to new patients. A 1:100,000 v/v dilution of concentrate is usually satisfactory to start treatment. However, as a precaution against overdose, a skin test with the intended starting dose should be done to help evaluate the patient's sensitivity to the product. If the skin response is larger than 5 mm edema/15 mm erythema, the extract is too strong and must be diluted before it is given subcutaneously. The doses shown in the Dosage Schedule (Table 1) below are recommended unless the patient's skin test response and allergic history indicates that more dilute extract should be used.
Little is known about the required accumulated dosage of allergen that is needed to relieve symptoms. However, studies have shown that high dose immunotherapy is efficacious in the treatment of allergic rhinitis and asthma. For this reason, treatment with extract from Vial #5 is recommended, providing the patient can tolerate the extract without experiencing local or systemic reactions. Treatment with Vial #6 may be used for patients who have not had adverse reactions to extract in Vial #5 and who require more concentrated extract to control or relieve symptoms.
Patients who have received allergenic extract for maintenance therapy SHOULD NOT be given the same dose from a fresh vial of extract. IT IS ADVISABLE TO REDUCE THE DOSAGE OF FRESH EXTRACT TO ONE-FOURTH THE AMOUNT GIVEN FROM A PREVIOUS LOT OF EXTRACT MADE AT THE SAME CONCENTRATION AND BY THE SAME FORMULA.
Table 1 - Suggested Dosage Schedule No.
Vial #1
1:100,000 w/v
frequency twice
weekly
mL
Vial #2
1:10,000 w/v
frequency twice
weekly
mL
Vial #3
1:1,000 w/v
frequency once
weekly
mL
Vial #4
1:100 w/v
frequency once
weekly
mL
Vial #5
1:10 w/v
frequency every
two-four weeks
mL
Vial #6
Concentrate
frequency every
two-four weeks
mL
1
0.025
0.025
0.025
0.025
0.025
0.025
2
0.05
0.05 0.05 0.05 0.05 0.05 3
0.10
0.10
0.10
0.10
0.10
0.10
4
0.15
0.15
0.15
0.15
0.15
0.15
5
0.20
0.20
0.20
0.20
0.20
0.20
6
0.25
0.25
0.25
0.25
0.25
0.25
7
0.30
0.30
0.30
0.30
0.30
0.30
Supplied ⮝
Allergenic extract is supplied in dropper vials for scratch or prick testing and in 10, 30, and 50 mL vials for bulk use.
WARRANTY
Allermed Laboratories, Inc. certifies that allergenic extract prepared within the Laboratories meets the safety and sterility standards of the F.D.A. Because the Laboratories have no control over the conditions under which extract is sued, or the purposes intended, neither a good nor a bad effect following its administration is warranted.
The users of this product should be aware of the potential dangers involved in the injection of allergenic extract and accept the risk of any consequences resulting from such injections.
No representatives of the Laboratories may change this warranty whether written, oral or implied. The buyer or user must assume full responsibility for the product after it leaves the premises of the Laboratories.
References ⮝
- Levy, D.A., L.M., Lichtenstein, E.O. Goldstein and K. Ishizaka. Immunologic and cellular changes accompanying the therapy of pollen allergy. J. Clinical Investigations. 50:360, 1971.
- Evans, R., H. Pence, H. Kaplan and R. Rocklin. The effect of immunotherapy on humoral and cellular response in ragweed hayfever. J. Clinical Investigations. 57:1378, 1976.
- Ishizaka, K. Cellular events in the IgE antibody response. Adv. In Immunology. 23:50, 1976.
- Middleton, Elliott, Jr., C.E. Reed and E.F. Ellis (Eds.) Allergy, Principles and Practice Vols. 1&2, C.V. Mosby 1978.
- Sheldon, J.M., R.G. Lovell and K.P. Matthews. A Manual of Clinical Allergy. W.B. Saunders, 1967.
- Nelson, H.S. Diagnostic procedures in allergy. I. Allergy skin testing. Ann. Allergy. 51:411, 1983.
- Norma, P.S., W.L. Winkenwerder and L.M. Lichtenstein. Immunotherapy of hay fever with ragweed antigen E: comparisons with whole pollen extract and placebos. J. Allergy. 42:93, 1968.
- Milner, F.H. and E.C. Tees. Specific sensitivity to individual grass pollens in some hay fever patients. Clinical Allergy. 2:83, 1972.
- Frankland, A.W. and R. Augustine. Grass pollen antigens effective in treatment. Clinical Science. 23:95, 1962.
- Pence, H.L., D.Q. Mitchell, R.L. Greely, B.R. Updegraff and H.A. Selfridge. Immunotherapy for mountain cedar pollinosis: a double-blind controlled study. J. Allergy ad Clinical Immunology. 58:39, 1976.
- Taylor, W.W., J.L. Ohman, Jr. and F.C. Lowell. Immunotherapy in cat-induced asthma. Double-blind trial with evaluation of bronchial responses to cat allergen and histamine. J. Allergy and Clinical Immunology. 61:283. 1978.
- Lichtenstein, L.M., M.D. Valentine and A.K. Sobotka. Insect allergies. The state of the art. J. Allergy and Clinical Immunology. 61:268, 1978.
- Metzger, W.J., E. Turner and R. Patterson. The safety of immunotherapy during pregnancy. J. Allergy and Clinical Immunology. 61:268. 1978.
- Ouellette, J.J. Emergency management of allergic reactions. Modern Medicine 99, 1975.
Container Label ⮝
COTTONSEED
cottonseed injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-005 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COTTON SEED (UNII: DI0ZRJ0MXN) (COTTON SEED - UNII:DI0ZRJ0MXN) COTTON SEED 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-005-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-005-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-005-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-005-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
CULTIVATED OAT POLLEN
avena sativa injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-322 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVENA SATIVA POLLEN (UNII: A7IKY24TR7) (AVENA SATIVA POLLEN - UNII:A7IKY24TR7) AVENA SATIVA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-322-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-322-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-322-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-322-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
CURVULARIA
curvularia lunata injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-109 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCHLIOBOLUS LUNATUS (UNII: 4T82EA86AJ) (COCHLIOBOLUS LUNATUS - UNII:4T82EA86AJ) COCHLIOBOLUS LUNATUS 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-109-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-109-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-109-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-109-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
CYPRESS, ARIZONA POLLEN
cupressus arizonica injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-341 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CUPRESSUS ARIZONICA POLLEN (UNII: 232DMH0XVF) (CUPRESSUS ARIZONICA POLLEN - UNII:232DMH0XVF) CUPRESSUS ARIZONICA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-341-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-341-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-341-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-341-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
DANDELION POLLEN
taraxacum officinale injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-416 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TARAXACUM OFFICINALE POLLEN (UNII: WQ3S5294XY) (TARAXACUM OFFICINALE POLLEN - UNII:WQ3S5294XY) TARAXACUM OFFICINALE POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-416-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-416-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-416-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-416-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
DATE PALM POLLEN
phoenix dactylifera injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-387 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHOENIX DACTYLIFERA POLLEN (UNII: 2FV55IRB5B) (PHOENIX DACTYLIFERA POLLEN - UNII:2FV55IRB5B) PHOENIX DACTYLIFERA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-387-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-387-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-387-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-387-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
DESERT RAGWEED POLLEN
ambrosia dumosa injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-355 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA DUMOSA POLLEN (UNII: ZIO18VN6HJ) (AMBROSIA DUMOSA POLLEN - UNII:ZIO18VN6HJ) AMBROSIA DUMOSA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-355-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-355-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-355-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-355-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
DOCK, YELLOW POLLEN
rumex crispus injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-406 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (RUMEX CRISPUS POLLEN - UNII:V825XJG64G) RUMEX CRISPUS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-406-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-406-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-406-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-406-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
DOG HAIR
dog hair injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-006 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR) CANIS LUPUS FAMILIARIS HAIR 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-006-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-006-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-006-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-006-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
EASTERN COTTONWOOD POLLEN
populus deltoides injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-395 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-395-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-395-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-395-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-395-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
EASTERN SYCAMORE POLLEN
platanus occidentalis injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-391 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-391-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-391-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-391-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-391-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
EASTERN WHITE PINE POLLEN
pinus strobus injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-388 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PINUS STROBUS POLLEN (UNII: TX1ER5UV3T) (PINUS STROBUS POLLEN - UNII:TX1ER5UV3T) PINUS STROBUS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-388-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-388-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-388-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-388-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
ENGLISH PLANTAIN POLLEN
plantago lanceolata injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-389 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-389-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-389-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-389-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-389-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
ENGLISH WALNUT POLLEN
juglans regia injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-367 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUGLANS REGIA POLLEN (UNII: ARW43087I1) (JUGLANS REGIA POLLEN - UNII:ARW43087I1) JUGLANS REGIA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-367-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-367-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-367-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-367-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
EPICOCCUM
epicoccum nigrum injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-110 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-110-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-110-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-110-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-110-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
EUCALYPTUS POLLEN
eucalyptus globulus injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-347 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTUS GLOBULUS POLLEN (UNII: 7XW7TB10X9) (EUCALYPTUS GLOBULUS POLLEN - UNII:7XW7TB10X9) EUCALYPTUS GLOBULUS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-347-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-347-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-347-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-347-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
EUROPEAN OLIVE POLLEN
olea europea injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-383 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLEA EUROPAEA POLLEN (UNII: 43R41XZ627) (OLEA EUROPAEA POLLEN - UNII:43R41XZ627) OLEA EUROPAEA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-383-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-383-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-383-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-383-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
FALSE RAGWEED POLLEN
ambrosia acanthicarpa injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-351 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA ACANTHICARPA POLLEN (UNII: U2AI3H2J5Y) (AMBROSIA ACANTHICARPA POLLEN - UNII:U2AI3H2J5Y) AMBROSIA ACANTHICARPA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-351-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-351-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-351-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-351-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
FLAXSEED
flaxseed injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-010 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLAX SEED (UNII: 4110YT348C) (FLAX SEED - UNII:4110YT348C) FLAX SEED 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-010-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-010-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-010-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-010-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
FREMONT COTTONWOOD POLLEN
populus fremontii injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-396 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS FREMONTII POLLEN (UNII: 426RHB4302) (POPULUS FREMONTII POLLEN - UNII:426RHB4302) POPULUS FREMONTII POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-396-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-396-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-396-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-396-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
FUSARIUM
fusarium solani injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-111 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HAEMATONECTRIA HAEMATOCOCCA (UNII: 7TLR512M4A) (HAEMATONECTRIA HAEMATOCOCCA - UNII:7TLR512M4A) HAEMATONECTRIA HAEMATOCOCCA 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-111-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-111-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-111-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-111-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
GAMBELS OAK POLLEN
quercus gambelii injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-404 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS GAMBELII POLLEN (UNII: 9HC15X34LX) (QUERCUS GAMBELII POLLEN - UNII:9HC15X34LX) QUERCUS GAMBELII POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-404-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-404-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-404-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-404-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
GIANT RAGWEED POLLEN
ambrosia trifida injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-317 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-317-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-317-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-317-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-317-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
GLYCEROL-SALINE CONTROL
glycerol-saline diluent injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-818 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 0.53 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-818-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-818-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-818-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-818-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
GOAT EPITHELIA
goat epithelia injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-011 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPRA HIRCUS SKIN (UNII: JLG9853E2P) (CAPRA HIRCUS SKIN - UNII:JLG9853E2P) CAPRA HIRCUS SKIN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-011-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-011-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-011-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-011-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
GRAMA GRASS POLLEN
bouteloua spp. injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-326 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOUTELOUA GRACILIS POLLEN (UNII: 2XO08315X1) (BOUTELOUA GRACILIS POLLEN - UNII:2XO08315X1) BOUTELOUA GRACILIS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-326-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-326-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-326-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-326-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
GRAY (WHITE) BIRCH POLLEN
betula populifolia injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-325 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA POPULIFOLIA POLLEN (UNII: 23H70FYJ5U) (BETULA POPULIFOLIA POLLEN - UNII:23H70FYJ5U) BETULA POPULIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-325-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-325-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-325-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-325-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
GREASEWOOD POLLEN
sarcobatus vermiculatus injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-411 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SARCOBATUS VERMICULATUS POLLEN (UNII: 6532U64A3X) (SARCOBATUS VERMICULATUS POLLEN - UNII:6532U64A3X) SARCOBATUS VERMICULATUS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-411-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-411-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-411-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-411-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
GREEN ASH POLLEN
fraxinus pennsylvanica injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-358 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS PENNSYLVANICA POLLEN (UNII: 2WZG2G15WX) (FRAXINUS PENNSYLVANICA POLLEN - UNII:2WZG2G15WX) FRAXINUS PENNSYLVANICA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-358-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-358-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-358-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-358-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
GUINEA PIG EPITHELIA
guinea pig epithelia injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-012 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAVIA PORCELLUS SKIN (UNII: GM3H4U6QS8) (CAVIA PORCELLUS SKIN - UNII:GM3H4U6QS8) CAVIA PORCELLUS SKIN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-012-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-012-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-012-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-012-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
HACKBERRY POLLEN
celtis occidentalis injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-336 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CELTIS OCCIDENTALIS POLLEN (UNII: 68R9X9Y96X) (CELTIS OCCIDENTALIS POLLEN - UNII:68R9X9Y96X) CELTIS OCCIDENTALIS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-336-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-336-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-336-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-336-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
HAMSTER EPITHELIA
hamster epithelia injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-013 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MESOCRICETUS AURATUS SKIN (UNII: 3K873H631W) (MESOCRICETUS AURATUS SKIN - UNII:3K873H631W) MESOCRICETUS AURATUS SKIN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-013-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-013-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-013-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-013-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
HARD MAPLE POLLEN
acer saccharum injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-452 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-452-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-452-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-452-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-452-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
HAZELNUT POLLEN
corylus americana injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-340 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CORYLUS AMERICANA POLLEN (UNII: ZGS382Y3AV) (CORYLUS AMERICANA POLLEN - UNII:ZGS382Y3AV) CORYLUS AMERICANA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-340-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-340-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-340-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-340-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
HELMINTHOSPORIUM SATIVUM
helminthosporium sativum injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-112 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-112-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-112-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-112-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-112-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
HOG EPITHELIA
hog epithelia injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-014 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SUS SCROFA SKIN (UNII: 3EM4VW6TQN) (SUS SCROFA SKIN - UNII:3EM4VW6TQN) SUS SCROFA SKIN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-014-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-014-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-014-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-014-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
HORSE EPITHELIA
horse epithelia injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-015 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4) (EQUUS CABALLUS SKIN - UNII:88VZV9HGT4) EQUUS CABALLUS SKIN 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-015-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-015-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-015-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-015-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
HOUSE DUST
house dust injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-008 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 0.02 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-008-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-008-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-008-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-008-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
IODINE BUSH POLLEN
allenrolfea occidentalis injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-311 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLENROLFEA OCCIDENTALIS POLLEN (UNII: 5W6JAI84OI) (ALLENROLFEA OCCIDENTALIS POLLEN - UNII:5W6JAI84OI) ALLENROLFEA OCCIDENTALIS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-311-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-311-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-311-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-311-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
JOHNSON GRASS POLLEN
sorghum halepense injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-413 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-413-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-413-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-413-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-413-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
JUTE
jute injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-016 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CORCORUS CAPSULARIS FIBER (UNII: TVA75O7S63) (CORCORUS CAPSULARIS FIBER - UNII:TVA75O7S63) CORCORUS CAPSULARIS FIBER 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-016-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-016-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-016-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-016-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
KAPOK
kapok injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-017 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CEIBA PENTANDRA FIBER (UNII: 758Z9H9WV9) (CEIBA PENTANDRA FIBER - UNII:758Z9H9WV9) CEIBA PENTANDRA FIBER 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-017-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-017-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-017-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-017-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
KARAYA GUM
karaya gum injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-018 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KARAYA GUM (UNII: 73W9IQY50Q) (KARAYA GUM - UNII:73W9IQY50Q) KARAYA GUM 0.01 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-018-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-018-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-018-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-018-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
KOELERS GRASS POLLEN
koeleria cristata injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-375 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KOELERIA MACRANTHA POLLEN (UNII: IIC6H3WF6J) (KOELERIA MACRANTHA POLLEN - UNII:IIC6H3WF6J) KOELERIA MACRANTHA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-375-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-375-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-375-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-375-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
LAMBS QUARTERS POLLEN
chenopodium album injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-339 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-339-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-339-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-339-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-339-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
LENS SCALE POLLEN
atriplex lentiformis injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-440 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATRIPLEX LENTIFORMIS POLLEN (UNII: 86LWA5503I) (ATRIPLEX LENTIFORMIS POLLEN - UNII:86LWA5503I) ATRIPLEX LENTIFORMIS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-440-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-440-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-440-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-440-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
LINDEN POLLEN
tilia cordata injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-460 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TILIA CORDATA POLLEN (UNII: OCO1LJR5YN) (TILIA CORDATA POLLEN - UNII:OCO1LJR5YN) TILIA CORDATA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-460-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-460-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-460-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-460-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
LOMBARD POPLAR POLLEN
populus nigra injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-397 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS NIGRA POLLEN (UNII: 0MGE63QPFJ) (POPULUS NIGRA POLLEN - UNII:0MGE63QPFJ) POPULUS NIGRA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-397-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-397-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-397-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-397-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
MELALEUCA POLLEN
melaleuca leucadendron injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-380 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MELALEUCA QUINQUENERVIA POLLEN (UNII: NX974IRT8E) (MELALEUCA QUINQUENERVIA POLLEN - UNII:NX974IRT8E) MELALEUCA QUINQUENERVIA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-380-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-380-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-380-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-380-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
MESQUITE POLLEN
prosopis juliflora injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-400 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROSOPIS JULIFLORA POLLEN (UNII: 6EIJ3D04MR) (PROSOPIS JULIFLORA POLLEN - UNII:6EIJ3D04MR) PROSOPIS JULIFLORA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-400-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-400-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-400-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-400-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
MONILIA
monilia sitophila injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-113 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHRYSONILIA SITOPHILA (UNII: 296FK85FY6) (CHRYSONILIA SITOPHILA - UNII:296FK85FY6) CHRYSONILIA SITOPHILA 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-113-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-113-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-113-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-113-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
MOUNTAIN CEDAR POLLEN
juniperus sabinoides injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-371 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-371-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-371-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-371-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-371-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
MOUSE EPITHELIA
mouse epithelia injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-019 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUS MUSCULUS SKIN (UNII: 390AN9GB09) (MUS MUSCULUS SKIN - UNII:390AN9GB09) MUS MUSCULUS SKIN 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-019-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-019-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-019-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-019-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
MUCOR
mucor racemosus injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-114 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUCOR RACEMOSUS (UNII: 17RH99LQ7G) (MUCOR RACEMOSUS - UNII:17RH99LQ7G) MUCOR RACEMOSUS 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-114-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-114-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-114-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-114-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
MUGWORT SAGE POLLEN
artemisia vulgaris injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-321 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (ARTEMISIA VULGARIS POLLEN - UNII:ANT994T71D) ARTEMISIA VULGARIS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-321-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-321-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-321-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-321-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
MUSTARD POLLEN
brassica campestris injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-327 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BRASSICA RAPA POLLEN (UNII: 85Z8OHV3K7) (BRASSICA RAPA POLLEN - UNII:85Z8OHV3K7) BRASSICA RAPA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-327-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-327-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-327-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-327-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
NETTLE POLLEN
urtica dioica injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-423 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength URTICA DIOICA POLLEN (UNII: DNB59M1NVU) (URTICA DIOICA POLLEN - UNII:DNB59M1NVU) URTICA DIOICA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-423-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-423-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-423-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-423-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
ORRIS ROOT
orris root injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-020 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IRIS GERMANICA VAR. FLORENTINA ROOT (UNII: M30XO5X4XD) (IRIS GERMANICA VAR. FLORENTINA ROOT - UNII:M30XO5X4XD) IRIS GERMANICA VAR. FLORENTINA ROOT 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-020-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-020-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-020-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-020-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
PALO VERDE POLLEN
cercidium torreyana injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-338 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PARKINSONIA FLORIDA POLLEN (UNII: 57586C96ZL) (PARKINSONIA FLORIDA POLLEN - UNII:57586C96ZL) PARKINSONIA FLORIDA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-338-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-338-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-338-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-338-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
PECAN POLLEN
carya illinoinensis injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-444 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-444-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-444-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-444-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-444-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
PENICILLIUM
penicillium chrysogenum injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-115 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-115-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-115-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-115-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-115-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
PEPPER TREE POLLEN
schinus molle injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-412 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SCHINUS MOLLE POLLEN (UNII: M0G28FH9K1) (SCHINUS MOLLE POLLEN - UNII:M0G28FH9K1) SCHINUS MOLLE POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-412-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-412-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-412-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-412-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
PHOMA
phoma betae injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-116 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLEOSPORA BETAE (UNII: V58BK047ES) (PLEOSPORA BETAE - UNII:V58BK047ES) PLEOSPORA BETAE 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-116-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-116-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-116-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-116-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
POVERTY WEED POLLEN
iva axillaris injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-363 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IVA AXILLARIS POLLEN (UNII: 13KFG30UBR) (IVA AXILLARIS POLLEN - UNII:13KFG30UBR) IVA AXILLARIS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-363-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-363-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-363-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-363-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
PRIVET POLLEN
ligustrum vulgare injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-376 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIGUSTRUM VULGARE POLLEN (UNII: Y3FRX92Z0E) (LIGUSTRUM VULGARE POLLEN - UNII:Y3FRX92Z0E) LIGUSTRUM VULGARE POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-376-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-376-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-376-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-376-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
PULLULARIA
pullularia pullulans injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-117 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.01 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-117-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-117-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-117-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-117-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
PUSSY WILLOW POLLEN
salix discolor injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-407 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALIX DISCOLOR POLLEN (UNII: ER172J09FM) (SALIX DISCOLOR POLLEN - UNII:ER172J09FM) SALIX DISCOLOR POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-407-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-407-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-407-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-407-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
QUACKGRASS POLLEN
agropyron repens injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-307 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ELYMUS REPENS POLLEN (UNII: ON2T85TA2O) (ELYMUS REPENS POLLEN - UNII:ON2T85TA2O) ELYMUS REPENS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-307-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-307-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-307-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-307-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
RABBITBUSH POLLEN
ambrosia deltoides injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-354 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA DELTOIDEA POLLEN (UNII: O4AB4546TP) (AMBROSIA DELTOIDEA POLLEN - UNII:O4AB4546TP) AMBROSIA DELTOIDEA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-354-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-354-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-354-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-354-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
RED ALDER POLLEN
alnus rubra injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-435 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALNUS RUBRA POLLEN (UNII: Z0F2YK1B7H) (ALNUS RUBRA POLLEN - UNII:Z0F2YK1B7H) ALNUS RUBRA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-435-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-435-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-435-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-435-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
RED CEDAR POLLEN
juniperus virginiana injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-373 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-373-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-373-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-373-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-373-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
RED MAPLE POLLEN
acer rubrum injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-434 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER RUBRUM POLLEN (UNII: 700NK45C76) (ACER RUBRUM POLLEN - UNII:700NK45C76) ACER RUBRUM POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-434-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-434-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-434-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-434-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
RED MULBERRY POLLEN
morus rubra injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-447 Route of Administration SUBCUTANEOUS, INTRADERMAL, CUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52) (MORUS RUBRA POLLEN - UNII:9LYI4RTZ52) MORUS RUBRA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-447-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-447-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-447-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-447-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
RED OAK POLLEN
quercus rubra injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-450 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (QUERCUS RUBRA POLLEN - UNII:SVW19ET93C) QUERCUS RUBRA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-450-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-450-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-450-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-450-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
REDROOT PIGWEED POLLEN
amaranthus retroflexus injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-314 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-314-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-314-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-314-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-314-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
RHIZOPUS
rhizopus oryzae injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-118 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RHIZOPUS ARRHIZUS (UNII: 8476849N1Y) (RHIZOPUS ARRHIZUS - UNII:8476849N1Y) RHIZOPUS ARRHIZUS 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-118-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-118-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-118-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-118-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
RIVER/RED BIRCH POLLEN
betula nigra injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-443 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-443-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-443-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-443-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-443-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
ROCKY MTN. JUNIPER POLLEN
juniperus scopulorum injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-372 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS SCOPULORUM POLLEN (UNII: 0G82TT8ZFY) (JUNIPERUS SCOPULORUM POLLEN - UNII:0G82TT8ZFY) JUNIPERUS SCOPULORUM POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-372-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-372-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-372-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-372-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
ROUGH MARSHELDER POLLEN
iva ciliata injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-364 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IVA ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-364-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-364-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-364-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-364-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
RUSSIAN OLIVE POLLEN
elaeagnus angustifolia injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-346 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ELAEAGNUS ANGUSTIFOLIA POLLEN (UNII: 68P4F4M6VD) (ELAEAGNUS ANGUSTIFOLIA POLLEN - UNII:68P4F4M6VD) ELAEAGNUS ANGUSTIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-346-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-346-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-346-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-346-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
RUSSIAN THISTLE POLLEN
salsola kali injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-410 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-410-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-410-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-410-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-410-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
RUST, WHEAT
puccinia striiformis injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-120 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PUCCINIA STRIIFORMIS VAR. STRIIFORMIS (UNII: 9NLW29GJAX) (PUCCINIA STRIIFORMIS VAR. STRIIFORMIS - UNII:9NLW29GJAX) PUCCINIA STRIIFORMIS VAR. STRIIFORMIS 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-120-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-120-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-120-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-120-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
SALT CEDAR POLLEN
tamarix gallica injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-415 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TAMARIX GALLICA POLLEN (UNII: 43IR7KR479) (TAMARIX GALLICA POLLEN - UNII:43IR7KR479) TAMARIX GALLICA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-415-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-415-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-415-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-415-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
SALT GRASS POLLEN
distichlis spicata injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-345 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DISTICHLIS SPICATA POLLEN (UNII: GOA51670YV) (DISTICHLIS SPICATA POLLEN - UNII:GOA51670YV) DISTICHLIS SPICATA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-345-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-345-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-345-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-345-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
SANDBUR RAGWEED POLLEN
ambrosia bipinnatifida injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-353 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA CHAMISSONIS POLLEN (UNII: 2Z41EEQ491) (AMBROSIA CHAMISSONIS POLLEN - UNII:2Z41EEQ491) AMBROSIA CHAMISSONIS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-353-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-353-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-353-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-353-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
SHAD SCALE POLLEN
atriplex confertifolia injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-439 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATRIPLEX CONFERTIFOLIA POLLEN (UNII: GG8WX068MX) (ATRIPLEX CONFERTIFOLIA POLLEN - UNII:GG8WX068MX) ATRIPLEX CONFERTIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-439-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-439-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-439-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-439-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
SHAGBARK HICKORY POLLEN
carya ovata injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-332 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARYA OVATA POLLEN (UNII: 54UN9R2798) (CARYA OVATA POLLEN - UNII:54UN9R2798) CARYA OVATA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-332-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-332-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-332-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-332-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
SHEEP SORREL POLLEN
rumex acetosella injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-405 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-405-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-405-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-405-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-405-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
SHORTLEAF PINE POLLEN
pinus echinata injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-448 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PINUS ECHINATA POLLEN (UNII: 96LRW14765) (PINUS ECHINATA POLLEN - UNII:96LRW14765) PINUS ECHINATA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-448-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-448-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-448-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-448-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
SILVER MAPLE POLLEN
acer saccharinum injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-304 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER SACCHARINUM POLLEN (UNII: 95447163DG) (ACER SACCHARINUM POLLEN - UNII:95447163DG) ACER SACCHARINUM POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-304-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-304-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-304-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-304-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
SILVER RAGWEED POLLEN
dicoria canescens injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-344 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DICORIA CANESCENS POLLEN (UNII: E9H4GR1NMP) (DICORIA CANESCENS POLLEN - UNII:E9H4GR1NMP) DICORIA CANESCENS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-344-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-344-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-344-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-344-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
SISAL
sisal injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-021 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AGAVE SISALANA FIBER (UNII: MRJ91HVV4H) (AGAVE SISALANA FIBER - UNII:MRJ91HVV4H) AGAVE SISALANA FIBER 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-021-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-021-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-021-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-021-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
SLENDER RAGWEED POLLEN
ambrosia tenuifolia injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-356 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA TENUIFOLIA POLLEN (UNII: 57W5SO585B) (AMBROSIA TENUIFOLIA POLLEN - UNII:57W5SO585B) AMBROSIA TENUIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-356-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-356-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-356-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-356-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
SMOOTH BROME POLLEN
bromus inermis injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-328 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMUS INERMIS POLLEN (UNII: 766QT72BK6) (BROMUS INERMIS POLLEN - UNII:766QT72BK6) BROMUS INERMIS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-328-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-328-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-328-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-328-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
SMUT, CORN
ustilago maydis injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-122 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG) USTILAGO MAYDIS 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-122-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-122-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-122-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-122-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
SMUT, JOHNSON GRASS
sphacelotheca cruenta injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-123 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SPORISORIUM CRUENTUM (UNII: GQM6LVU5V8) (SPORISORIUM CRUENTUM - UNII:GQM6LVU5V8) SPORISORIUM CRUENTUM 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-123-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-123-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-123-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-123-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
SMUT, WHEAT
tilletia caries (tritici) injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-124 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TILLETIA CARIES (UNII: C7000B9PQI) (TILLETIA CARIES - UNII:C7000B9PQI) TILLETIA CARIES 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-124-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-124-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-124-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-124-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
SPRING BIRCH POLLEN
betula fontinalis injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-441 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA OCCIDENTALIS POLLEN (UNII: R889N2L976) (BETULA OCCIDENTALIS POLLEN - UNII:R889N2L976) BETULA OCCIDENTALIS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-441-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-441-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-441-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-441-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
STEMPHYLIUM
stemphylium botryosum injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-126 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLEOSPORA TARDA (UNII: TPL549N9R8) (PLEOSPORA TARDA - UNII:TPL549N9R8) PLEOSPORA TARDA 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-126-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-126-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-126-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-126-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
SUGAR BEET POLLEN
beta vulgaris injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-324 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETA VULGARIS POLLEN (UNII: W7NU4B5CIY) (BETA VULGARIS POLLEN - UNII:W7NU4B5CIY) BETA VULGARIS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-324-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-324-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-324-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-324-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
SUNFLOWER POLLEN
helianthus annua injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-360 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HELIANTHUS ANNUUS POLLEN (UNII: 28D6K7E9IP) (HELIANTHUS ANNUUS POLLEN - UNII:28D6K7E9IP) HELIANTHUS ANNUUS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-360-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-360-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-360-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-360-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
SWEET GUM POLLEN
liquidamber styraciflua injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-377 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (LIQUIDAMBAR STYRACIFLUA POLLEN - UNII:5Q246DS5BS) LIQUIDAMBAR STYRACIFLUA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-377-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-377-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-377-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-377-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
TAG ALDER POLLEN
alnus rugosa injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-436 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALNUS INCANA SUBSP. RUGOSA POLLEN (UNII: 605T96G8Y5) (ALNUS INCANA SUBSP. RUGOSA POLLEN - UNII:605T96G8Y5) ALNUS INCANA SUBSP. RUGOSA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-436-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-436-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-436-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-436-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
TOBACCO LEAF
tobacco leaf injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-022 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU) TOBACCO LEAF 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-022-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-022-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-022-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-022-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
TREE OF HEAVEN POLLEN
ailanthus altissima injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-310 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AILANTHUS ALTISSIMA POLLEN (UNII: 2A64U81OQ3) (AILANTHUS ALTISSIMA POLLEN - UNII:2A64U81OQ3) AILANTHUS ALTISSIMA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-310-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-310-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-310-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-310-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
UTAH JUNIPER POLLEN
juniperus osteosperma injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-370 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS OSTEOSPERMA POLLEN (UNII: 15L060HV8H) (JUNIPERUS OSTEOSPERMA POLLEN - UNII:15L060HV8H) JUNIPERUS OSTEOSPERMA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-370-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-370-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-370-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-370-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
VELVET GRASS POLLEN
holcus lanatus injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-361 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOLCUS LANATUS POLLEN (UNII: 70O1TP6H01) (HOLCUS LANATUS POLLEN - UNII:70O1TP6H01) HOLCUS LANATUS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-361-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-361-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-361-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-361-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
WESTERN JUNIPER POLLEN
juniperus occidentalis injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-369 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS OCCIDENTALIS POLLEN (UNII: 7JWJ3HXZ9U) (JUNIPERUS OCCIDENTALIS POLLEN - UNII:7JWJ3HXZ9U) JUNIPERUS OCCIDENTALIS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-369-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-369-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-369-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-369-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
WESTERN RAGWEED POLLEN
ambrosia psilostachia injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-316 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (AMBROSIA PSILOSTACHYA POLLEN - UNII:RX18M46K8L) AMBROSIA PSILOSTACHYA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-316-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-316-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-316-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-316-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
WESTERN SYCAMORE POLLEN
platanus racemosa injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-392 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLATANUS RACEMOSA POLLEN (UNII: BWC8DYU8OS) (PLATANUS RACEMOSA POLLEN - UNII:BWC8DYU8OS) PLATANUS RACEMOSA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-392-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-392-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-392-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-392-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
WESTERN WATERHEMP POLLEN
acnida tamariscina injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-305 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS TUBERCULATUS POLLEN (UNII: 92N6W6KO2G) (AMARANTHUS TUBERCULATUS POLLEN - UNII:92N6W6KO2G) AMARANTHUS TUBERCULATUS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-305-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-305-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-305-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-305-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
WESTERN WHEATGRASS POLLEN
agropyron smithii injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-308 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASCOPYRUM SMITHII POLLEN (UNII: 6AU0ZD8T1O) (PASCOPYRUM SMITHII POLLEN - UNII:6AU0ZD8T1O) PASCOPYRUM SMITHII POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-308-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-308-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-308-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-308-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
WHITE ASH POLLEN
fraxinus americana injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-357 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-357-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-357-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-357-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-357-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
WHITE HICKORY POLLEN
carya tomentosa injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-334 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-334-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-334-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-334-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-334-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
WHITE MULBERY POLLEN
morus alba injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-382 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MORUS ALBA POLLEN (UNII: 3I9T68187H) (MORUS ALBA POLLEN - UNII:3I9T68187H) MORUS ALBA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-382-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-382-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-382-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-382-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
WHITE OAK POLLEN
quercus alba injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-402 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-402-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-402-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-402-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-402-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
WHITE POPLAR POLLEN
populus alba injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-394 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS ALBA POLLEN (UNII: VU8C8SB23P) (POPULUS ALBA POLLEN - UNII:VU8C8SB23P) POPULUS ALBA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-394-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-394-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-394-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-394-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
WING SCALE POLLEN
atriplex canescens injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-438 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATRIPLEX CANESCENS POLLEN (UNII: 26U0BU8G83) (ATRIPLEX CANESCENS POLLEN - UNII:26U0BU8G83) ATRIPLEX CANESCENS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-438-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-438-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-438-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-438-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
WINTERFAT POLLEN
eurotia lanata injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-348 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KRASCHENINNIKOVIA LANATA POLLEN (UNII: 0GTO5BR99M) (KRASCHENINNIKOVIA LANATA POLLEN - UNII:0GTO5BR99M) KRASCHENINNIKOVIA LANATA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-348-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-348-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-348-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-348-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
WORMWOOD SAGE POLLEN
artemisia absinthium injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-319 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA ABSINTHIUM POLLEN (UNII: 81GS97HVFO) (ARTEMISIA ABSINTHIUM POLLEN - UNII:81GS97HVFO) ARTEMISIA ABSINTHIUM POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-319-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-319-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-319-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-319-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
YELLOW PINE POLLEN
pinus ponderosa injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-449 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PINUS PONDEROSA POLLEN (UNII: 042SUA2DS9) (PINUS PONDEROSA POLLEN - UNII:042SUA2DS9) PINUS PONDEROSA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-449-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-449-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-449-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-449-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
ACACIA POLLEN
acacia spp. injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-301 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACACIA POLLEN (UNII: 43DDR2YDYZ) (ACACIA POLLEN - UNII:43DDR2YDYZ) ACACIA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-301-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-301-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-301-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-301-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
WALNUT MIX
walnut mix injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-544 Route of Administration PERCUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.0167 g in 1 mL JUGLANS REGIA POLLEN (UNII: ARW43087I1) (JUGLANS REGIA POLLEN - UNII:ARW43087I1) JUGLANS REGIA POLLEN 0.0167 g in 1 mL JUGLANS CALIFORNICA POLLEN (UNII: 2147EPR64I) (JUGLANS CALIFORNICA POLLEN - UNII:2147EPR64I) JUGLANS CALIFORNICA POLLEN 0.0167 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.5 g in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-544-01 1 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:49643-544-05 5 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:49643-544-10 10 mL in 1 VIAL; Type 0: Not a Combination Product 4 NDC:49643-544-30 30 mL in 1 VIAL; Type 0: Not a Combination Product 5 NDC:49643-544-50 50 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
ALTERNARIA
alternaria alternata injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-101 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-101-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-101-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-101-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-101-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
ALDER, WHITE POLLEN
alnus rhombifolia injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-312 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALNUS RHOMBIFOLIA POLLEN (UNII: 7X8HL8GRTM) (ALNUS RHOMBIFOLIA POLLEN - UNII:7X8HL8GRTM) ALNUS RHOMBIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-312-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-312-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-312-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-312-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
ALFALFA POLLEN
medicago sativa injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-300 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MEDICAGO SATIVA POLLEN (UNII: G515RAI9FY) (MEDICAGO SATIVA POLLEN - UNII:G515RAI9FY) MEDICAGO SATIVA POLLEN 0.02 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-300-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-300-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-300-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-300-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
ALKALI BLITE POLLEN
suaeda spp. injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-414 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SUAEDA NIGRA POLLEN (UNII: FZU040QDS7) (SUAEDA NIGRA POLLEN - UNII:FZU040QDS7) SUAEDA NIGRA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-414-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-414-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-414-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-414-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
AMERICAN ELM POLLEN
ulmus americana injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-417 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-417-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-417-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-417-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-417-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
ARIZONA ASH POLLEN
fraxinus velutina injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-359 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS VELUTINA POLLEN (UNII: LJT6I6Z8FD) (FRAXINUS VELUTINA POLLEN - UNII:LJT6I6Z8FD) FRAXINUS VELUTINA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-359-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-359-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-359-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-359-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
ARROYO WILLOW POLLEN
salix lasiolepsis injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-408 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALIX LASIOLEPIS POLLEN (UNII: 808UWJ59FI) (SALIX LASIOLEPIS POLLEN - UNII:808UWJ59FI) SALIX LASIOLEPIS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-408-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-408-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-408-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-408-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
ASPEN POLLEN
populus tremuloides injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-398 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS TREMULOIDES POLLEN (UNII: 928OC2TJDA) (POPULUS TREMULOIDES POLLEN - UNII:928OC2TJDA) POPULUS TREMULOIDES POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-398-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-398-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-398-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-398-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
ASPERGILLUS FUMIGATUS
aspergillus fumigatus injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-130 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-130-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-130-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-130-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-130-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
AUSTRALIAN PINE POLLEN
casuarina equisetifoli injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-335 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CASUARINA EQUISETIFOLIA POLLEN (UNII: OZJ4OE173N) (CASUARINA EQUISETIFOLIA POLLEN - UNII:OZJ4OE173N) CASUARINA EQUISETIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-335-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-335-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-335-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-335-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
BAHIA GRASS POLLEN
paspalum notatum injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-384 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK) PASPALUM NOTATUM POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-384-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-384-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-384-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-384-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
BASSIA POLLEN
bassia hyssopifolia injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-323 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BASSIA HYSSOPIFOLIA POLLEN (UNII: 35487N1IC9) (BASSIA HYSSOPIFOLIA POLLEN - UNII:35487N1IC9) BASSIA HYSSOPIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-323-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-323-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-323-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-323-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
BEECH POLLEN
fagus grandifolia injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-349 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4) (FAGUS GRANDIFOLIA POLLEN - UNII:34X886W1H4) FAGUS GRANDIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-349-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-349-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-349-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-349-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
BLACK COTTONWOOD POLLEN
populus trichocarpa injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-399 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS TRICHOCARPA POLLEN (UNII: H8QYU50Z2D) (POPULUS TRICHOCARPA POLLEN - UNII:H8QYU50Z2D) POPULUS TRICHOCARPA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-399-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-399-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-399-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-399-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
BLACK OAK POLLEN
quercus velutina injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-451 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS VELUTINA POLLEN (UNII: 294L626TT0) (QUERCUS VELUTINA POLLEN - UNII:294L626TT0) QUERCUS VELUTINA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-451-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-451-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-451-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-451-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
BLACK WALNUT POLLEN
juglans nigra injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-366 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-366-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-366-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-366-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-366-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
BLACK WILLOW POLLEN
salix nigra injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-409 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-409-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-409-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-409-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-409-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
BOTRYTIS
botrytis cinerea injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-104 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOTRYTIS CINEREA (UNII: TBW53313S7) (BOTRYTIS CINEREA - UNII:TBW53313S7) BOTRYTIS CINEREA 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-104-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-104-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-104-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-104-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
BOTTLEBRUSH POLLEN
callistemon citrinus injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-330 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALLISTEMON CITRINUS POLLEN (UNII: 62OII98F1T) (CALLISTEMON CITRINUS POLLEN - UNII:62OII98F1T) CALLISTEMON CITRINUS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-330-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-330-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-330-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-330-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
BOX ELDER MAPLE POLLEN
acer negundo injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-303 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-303-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-303-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-303-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-303-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
BURNING BUSH POLLEN
kochia scoparia injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-374 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (BASSIA SCOPARIA POLLEN - UNII:07A108ZKW5) BASSIA SCOPARIA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-374-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-374-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-374-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-374-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
BURROBRUSH POLLEN
hymenoclea salsola injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-362 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA SALSOLA POLLEN (UNII: 662J7FTA7T) (AMBROSIA SALSOLA POLLEN - UNII:662J7FTA7T) AMBROSIA SALSOLA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-362-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-362-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-362-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-362-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
BURWEED MARSHELDER POLLEN
iva xanthifolia injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-365 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYCLACHAENA XANTHIFOLIA POLLEN (UNII: V80TPZ0T6J) (CYCLACHAENA XANTHIFOLIA POLLEN - UNII:V80TPZ0T6J) CYCLACHAENA XANTHIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-365-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-365-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-365-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-365-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
CALIF. BLACK WALNUT POLLEN
juglans californica injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-446 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUGLANS CALIFORNICA POLLEN (UNII: 2147EPR64I) (JUGLANS CALIFORNICA POLLEN - UNII:2147EPR64I) JUGLANS CALIFORNICA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-446-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-446-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-446-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-446-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
CALIFORNIA JUNIPER POLLEN
juniperus californica injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-368 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS CALIFORNICA POLLEN (UNII: 0H1V4V5V9L) (JUNIPERUS CALIFORNICA POLLEN - UNII:0H1V4V5V9L) JUNIPERUS CALIFORNICA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-368-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-368-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-368-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-368-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
CALIFORNIA SCRUB OAK POLLEN
quercus dumosa injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-403 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS DUMOSA POLLEN (UNII: P5W45RU6E4) (QUERCUS DUMOSA POLLEN - UNII:P5W45RU6E4) QUERCUS DUMOSA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-403-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-403-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-403-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-403-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
CANARY GRASS POLLEN
phalaris arundinaceae injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-385 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHALARIS ARUNDINACEA POLLEN (UNII: FAY1Y90VJ9) (PHALARIS ARUNDINACEA POLLEN - UNII:FAY1Y90VJ9) PHALARIS ARUNDINACEA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-385-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-385-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-385-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-385-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
CANDIDA
candida albicans injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-105 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-105-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-105-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-105-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-105-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
CANYON RAGWEED POLLEN
ambrosia ambrosioides injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-352 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA AMBROSIOIDES POLLEN (UNII: 81214Y871U) (AMBROSIA AMBROSIOIDES POLLEN - UNII:81214Y871U) AMBROSIA AMBROSIOIDES POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-352-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-352-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-352-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-352-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
CARELESS WEED POLLEN
amaranthus palmerii injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-313 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH) (AMARANTHUS PALMERI POLLEN - UNII:1GH3WV23KH) AMARANTHUS PALMERI POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-313-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-313-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-313-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-313-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
CATTLE EPITHELIA
cattle epithelia injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-003 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOS TAURUS SKIN (UNII: 7J12CD6O9L) (BOS TAURUS SKIN - UNII:7J12CD6O9L) BOS TAURUS SKIN 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-003-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-003-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-003-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-003-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
CEPHALOSPORIUM
cephalosporium roseum injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-106 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CEPHALOSPORIUM ROSEUM (UNII: 1756J4PM8P) (CEPHALOSPORIUM ROSEUM - UNII:1756J4PM8P) CEPHALOSPORIUM ROSEUM 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-106-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-106-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-106-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-106-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
CHAETOMIUM
chaetomium globosum injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-107 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHAETOMIUM GLOBOSUM (UNII: 5016WB8B8A) (CHAETOMIUM GLOBOSUM - UNII:5016WB8B8A) CHAETOMIUM GLOBOSUM 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-107-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-107-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-107-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-107-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
CHEAT GRASS POLLEN
bromus secalinus injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-329 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMUS SECALINUS POLLEN (UNII: Q4T1SJ3046) (BROMUS SECALINUS POLLEN - UNII:Q4T1SJ3046) BROMUS SECALINUS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-329-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-329-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-329-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-329-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
CHERRY BIRCH POLLEN
betula lenta injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-442 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-442-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-442-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-442-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-442-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
CHINESE ELM POLLEN
ulmus pumila injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-419 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ULMUS PUMILA POLLEN (UNII: 030R993R8E) (ULMUS PUMILA POLLEN - UNII:030R993R8E) ULMUS PUMILA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-419-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-419-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-419-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-419-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
CLADOSPORIUM
cladosporium herbarum injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-108 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM HERBARUM (UNII: O64JF11198) (CLADOSPORIUM HERBARUM - UNII:O64JF11198) CLADOSPORIUM HERBARUM 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-108-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-108-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-108-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-108-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
COAST LIVE OAK POLLEN
quercus agrifolia injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-401 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS AGRIFOLIA POLLEN (UNII: VOT5MA71M7) (QUERCUS AGRIFOLIA POLLEN - UNII:VOT5MA71M7) QUERCUS AGRIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-401-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-401-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-401-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-401-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
COAST MAPLE POLLEN
acer macrophyllum injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-302 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER MACROPHYLLUM POLLEN (UNII: E4CG5Q55M1) (ACER MACROPHYLLUM POLLEN - UNII:E4CG5Q55M1) ACER MACROPHYLLUM POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-302-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-302-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-302-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-302-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
COAST SAGE POLLEN
artemisia californica injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-437 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA CALIFORNICA POLLEN (UNII: 1EDY616508) (ARTEMISIA CALIFORNICA POLLEN - UNII:1EDY616508) ARTEMISIA CALIFORNICA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-437-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-437-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-437-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-437-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
COCKLEBUR POLLEN
xanthium commune injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-420 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength XANTHIUM STRUMARIUM POLLEN (UNII: 2QOF601J1M) (XANTHIUM STRUMARIUM POLLEN - UNII:2QOF601J1M) XANTHIUM STRUMARIUM POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-420-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-420-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-420-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-420-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
COCKROACH, AMERICAN
periplaneta americana injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-047 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-047-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-047-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-047-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-047-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
COCKROACH, GERMAN
blattella germanica injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-048 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLATTELLA GERMANICA (UNII: G9O67I0A8Q) (BLATTELLA GERMANICA - UNII:G9O67I0A8Q) BLATTELLA GERMANICA 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-048-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-048-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-048-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-048-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
COMMON SAGE POLLEN
artemisia tridentata injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-320 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA TRIDENTATA POLLEN (UNII: YI19RB8YFD) (ARTEMISIA TRIDENTATA POLLEN - UNII:YI19RB8YFD) ARTEMISIA TRIDENTATA POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-320-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-320-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-320-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-320-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
CORN POLLEN POLLEN
zea mays injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-422 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZEA MAYS POLLEN (UNII: 74PD8J616H) (ZEA MAYS POLLEN - UNII:74PD8J616H) ZEA MAYS POLLEN 0.05 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-422-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-422-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-422-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-422-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
COTTON LINTERS
cotton linters injection
Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-004 Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COTTON FIBER (UNII: 70LDW53ROO) (COTTON FIBER - UNII:70LDW53ROO) COTTON FIBER 0.1 g in 1 mL
Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0025 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00125 g in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.53 g in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 g in 1 mL WATER (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-004-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:49643-004-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:49643-004-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 4 NDC:49643-004-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102211 03/12/1974
Labeler - Allermed Laboratories, Inc. (073364531)
Establishment Name Address ID/FEI Business Operations Allermed Laboratories, Inc. 073364531 manufacture Revised: 9/2019 Document Id: 92c655c3-b9ec-6712-e053-2a95a90a8241 Set id: f81e793d-d51a-401c-b081-34c044fb9f01 Version: 4 Effective Time: 20190917 Allermed Laboratories, Inc.
