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ALLERGENIC EXTRACTSINDIVIDUAL TREATMENT VIAL


  1. Warnings
  2. Description
  3. Clinical Pharmacology
  4. Indications And Usage
  5. Contraindications
  6. General Precautions
  7. Dosage And Administration
  8. Adverse Reactions
  9. Overdosage
  10. How Supplied
  11. References
  12. Container Labeling

Warnings 

Epinephrine 1:1000 should be available.

When changing immunotherapy from an unstandardized to an AU/ml standardized allergenic extract, dose adjustment, if indicated, should be based on the comparative potency of the extracts. Patient re-evaluation may be necessary.

Injections should never be given intravenously. A 5/8 inch 25 gauge needle on a sterile syringe will allow deep subcutaneous injection. Precaution of withdrawing the plunger slightly after inserting the needle is advisable to determine if a blood vessel has been entered. Proper measurement of the dose and caution in making the injection will minimize reactions. Patients should be detained for twenty to thirty minutes after injection or advised to return to the office immediately if symptoms or reactions occur.

Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death.

Description 

Allergenic extract in this vial is referred to as an individual treatment vial since it is designed primarily for the physician equipped to complete skin testing and supervise allergenic extract immunotherapy. The extract is sterile and intended for subcutaneous injection. The concentration of allergenic extract supplied will be based on the individual physician's prescription order and will be expressed in most cases on a weight/volume basis (or AU/ml with standardized extract) diluted either 1:10 or 1:5. Where mixtures of pollens and non-pollens have been ordered, the ingredients are listed on the final container label. To insure maximum potency for the entire dating period, dilutions will be prepared with 50% v/v glycerine unless otherwise specified.

Ingredients - Active allergens, preservative and stabilizer are noted on the Physicians Prescription Ingredients Insert enclosed with each individual allergenic extract treatment vial.

Dating Period - A twelve month dating period (expiration date) for the prescription vial will be on the container label. Extract Treatment Sets should be reordered when outdated. Government requirements include a two week holding period for sterility tests. Please allow three weeks minimum for delivery.

Clinical Pharmacology 

The mechanisms by which immunotherapy (hyposensitization) is achieved are not completely understood. Anaphylaxis or "anaphylactic shock," and hay fever are caused by the same basic process: the production of IgE antibody, its attachment to mast cells and, on renewed contact with the same antigen explosive degranulation of the mast cells and release of mediators, which act on smooth muscle, mucous glands, and blood vessels. With massive release there is bronchospasm, vomiting, skin rashes, edema of the nose and throat, and vascular collapse, sometimes fatal, while with more localized release one or more of these symptoms predominates, depending on the site (tissue shock organ) of exposure to the antigen.

Antigens that can trigger these reactions are known as "allergens"; they have very diverse origins but a curious similarity of molecular weight. People who suffer unduly from allergy are called "atopic"; this trait is usually inherited and has been attributed to a variety of constitutional abnormalities.

The IgE dependent degranulation of mast cells is initiated by the bridging of pairs of cell-bound IgE by antigen and terminates rapidly. Bridging results in alteration of the cell membrane, which is associated with increased energy dependent entry of calcium, alterations in phospholipid metabolism and increase of cyclic adenosine monophosphate (cyclic AMP).

The mast cell membrane is ruffled and possesses receptors both for the Fc portion of IgE and C3b. Receptors for anaphylatoxin (C3a and C5a), have been defined functionally. In addition to IgE antigen interaction and stimulation by anaphylatoxin, mast cells may be degranulated by non-immunological stimuli such as enzymes, ionophores, polycations, radio-contrast dyes and opiates. Atopic individuals develop their symptoms principally as a result of IgE-dependent processes; however, non- IgE mediated mechanisms for the release of mast cell mediators provide additional potential for recruitment of mediators.

Subsequent to activation, the secretion of granules is under cyclic nucleotide regulation. Of direct relevance is the possibility that the mast cell itself, by histamine (H2) and prostaglandins (E2, D2, I2) may increase cyclic AMP and inhibit secretion. Conversely histamine (H1) could elevate cyclic GMP and PGF, 2 alpha lower cyclic AMP, augmenting the release of mediators. 18

Indications And Usage 

When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to the cause of a person's allergic condition can be gleaned from a thorough history and careful physical examination. Diagnostic tests - in vitro or in vivo - serve only to confirm the physician's suspicions or to improve investigative skills. Specific diagnosis is especially indicated when the patient's symptoms are not controlled by medication. When immunotherapy is contemplated demonstration of sensitivity to a specific allergenic extract is necessary. An orderly approach to the use of diagnostic tests usually begins with direct skin testing. 5,6,11

THIS PRODUCT IS NOT INTENDED FOR TREATMENT OF PATIENTS WHO DO NOT MANIFEST IMMEDIATE HYPERSENSITIVITY REACTIONS TO THE ALLERGENIC EXTRACT FOLLOWING SKIN TESTING.

Contraindications 

There are no absolute contraindications; however, extreme caution is necessary when using diagnostic skin tests or injection treatment in highly sensitive patients, who have experienced severe symptoms or anaphylaxis by natural exposure or previous skin testing or treatment. IN THESE CASES BOTH THE POTENCY FOR SKIN TESTS AND THE ESCALATION OF THE TREATMENT DOSE MUST BE ADJUSTED TO THE PATIENT S SENSlTIVITY AND TOLERANCE.

This product is not intended for the treatment of patients who do not experience allergic symptoms upon natural exposure to the allergen. At the present time there has been no demonstrated adverse effects on the fetus when allergenic extract immunotherapy is administered during gestation to pregnant women.

100,000 AU/ml standardized allergenic extract should be used by physicians with experience in maximal dose immunotherapy and treatment of anaphylaxis.

General Precautions 

Pregnancy Category C: There are no adequate and well controlled studies in pregnant women. Allergenic extracts should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pediatric Use: Doses of allergenic extracts for children are generally the same as those for adults. The maximum volume of extract tolerated without undue pain and swelling may be less for smaller individuals and therefore the maximum dose and treatment schedule must be individualized.

Animal reproduction studies have not been conducted with allergenic extracts. It is also not known whether allergenic extracts can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Allergenic extracts should be given to a pregnant woman only if clearly needed. 15

Refrigerate at 2-8 degrees C.

Sterile solutions, vials, syringes, etc. should be used. Aseptic technique should be observed when making dilutions, skin testing, and extracts for treatment. The usual precautions in administering allergenic extracts are necessary.

A separate autoclave sterilized or disposable syringe and needle should be used for each individual patient to prevent transmission of serum hepatitis, A.I.D.S. and other infectious agents from one person to another.

The initial dilution of allergen extract, starting dose, and progression of dosage must be carefully determined on the basis of the patient's history and results of skin tests. Patients with a history of severe sensitivity and markedly positive skin tests to high dilutions of the allergen extract should be started with low doses of highly diluted extract. Pregnancy or a history of prior reactions to allergen immunotherapy dictates the need to start with small quantities of antigen.

If the first injection of the initial dilution of extract is tolerated without significant local reaction, increasing doses by 5-20% increments of that dilution may be administered. The rate of increase in dosage in the early stages of treatment with highly diluted extracts is usually more rapid than the rate of increase possible with more concentrated extracts. This schedule is intended only as a guide and must be modified according to the reactivity of the individual patient. Needless to say, the physician must proceed cautiously in the treatment of the highly sensitive patient who develops large local or systemic reactions.

Some patients may tolerate larger doses, but it is rarely necessary to give maintenance doses larger than 2,000 AU/ml of the standardized extract or 0.5 ml of 1:100 w/v of the unstandardized extract. Because dilute extracts tend to lose activity on storage, the first dose from a more concentrated vial, should be the same or less than the previous dose.1,2,3,4,16

Immunotherapy must be given under the supervision of a physician. Before an injection is given the patient should be asked about any reaction following the previous injection to help determine the next dose. Target maintenance dose should be determined by the physician s experience and patient response to skin testing and treatment.

Dosages progressively increase thereafter according to the tolerance of the patient at intervals of one to seven days until, (1) the patient achieves relief of symptoms, (2) induration at the site of injection is no larger than 50 mm in 36 to 48 hours, (3) a maintenance dose short of aggravating existing symptoms, systemic symptoms, or anaphylaxis. The dose should be escalated until the patient is receiving a final maintenance dose containing 2.7 to 22 u/ml or more of ragweed AgE (using Short Ragweed as example) or demonstrates untoward reactions that indicate the dose to be excessive. This maintenance dose may be continued at regular intervals perennially or achieved each year by a new, but shortened course of treatment. It may be necessary to adjust the progression of dosage downward to avoid local and constitutional reactions.

Immunotherapy of patients highly sensitive to ragweed pollen (using Short Ragweed as an example) receiving a dose of 2.7 to 46.8 units of ragweed AgE (1,000-2,000 or more AU/ml of standardized ragweed extract) was significantly more effective than placebo for (1) relieving symptoms of ragweed hay fever, (2) producing increase in serum levels of anti-ragweed IgG, (3) decrease in seasonal rises in levels of anti-ragweed IgE, (4) decrease in leukocyte histamine release from exposure to ragweed pollen extract in some patients, and (5) increase in IgG and IgA antibodies in nasal secretions. 17

In addition to these changes in humoral antibody production, immunotherapy also effects some cellular changes. Basophils from treated subjects release less histamine in vitro and are less sensitive to the allergen (that is, higher concentrations of allergens are required to induce histamine release) than are basophils from non-treated patients. Lymphocytes from treated patients exhibit decreased proliferative response and decreased production of lymphokine in the presence of the specific allergen. A state of tolerance may be induced in the IgE producing B lymphocytes, there may be impairment in T-lymphocyte helper function, or immunotherapy may generate suppressor cells. Antigen specific suppressor cells, probably bearing histamine receptors, are generated during immunotherapy for allergy and may be partly responsible for the efficacy of this therapy. 14

Loss of potency of aqueous pollen extracts has been recognized as a problem since shortly after the introduction of modern methods of immunotherapy. This loss of potency occurs more rapidly in saline extracts without added preservatives at high temperature and at greater extract dilutions. At concentrations of 1:100 all dilutions containing glycerin, human serum albumin, maintained extract potency within 1 logarithm (log) dilution of the original strength for 12 months; glycerin was significantly superior to all other extracts at 1, 3, and 12 months; and the deleterious effect of phenol was minimal. The deleterious effect of phenol was more marked at the higher dilutions. It was concluded that there may be marked loss of potency of dilute pollen extracts stored for periods of only two weeks under conditions which may be encountered in normal clinical practice. 12

Dosage And Administration 

As a consequence of the discovery of IgE and the development of methods to identify and quantify anti-allergen IgE levels, interest in recent years has centered around the utilization of in vivo and in vitro diagnostic procedures. 7,9

Patients who react to a small quantity of antigen by skin testing can be classified as highly sensitive. Those who react only to large quantities of antigen can be classified as less sensitive. It would appear that there is at least a 50,000-fold range between the most and least sensitive individuals. On the other hand, certain patients who do not appear to have elevated quantities of specific anti-allergen IgE do have positive skin tests and have symptoms of allergic rhinitis. These patients are considerably less sensitive than patients with detectable levels of specific IgE antibody. 10

The current standard method of immunotherapy dates back to the earliest studies by Noon. As adapted for ragweed pollen extract, therapy is begun with a low dose, which has been shown to be tolerated by both experience and skin testing.

The physician who undertakes immunotherapy should be concerned with the degree of sensitivity of the patient. This can be measured by skin test, leukocyte histamine release, or anti-allergen IgE levels. Strongly positive skin tests or high initial ragweed IgE and total IgE may be risk factors for systemic reactions. Less aggressive immunotherapy schedules may be indicated for such patients. Maintenance dose potency must be established by the physician's clinical observation and experience. 10,17

Serial fivefold or tenfold dilutions of the extract are used to make more dilute extract concentrations. Other concentrations can be prepared by appropriate dilution. In brief, the allergist can prepare any dilution of extract that is considered appropriate for the patient.

Adverse Reactions 

Systemic reactions may range from mild exaggeration of the patient s allergic symptoms to anaphylactic reactions. Very sensitive patients may show a rapid response. In some instances a severe systemic reaction with blood pressure fall and/or shock may occur. Quantitation of patient's sensitivity combined with careful early observation is essential for safe skin testing and treatment.

Other reactions include, but are not necessarily limited to urticaria, itching, edema of the extremities, respiratory wheezing or asthma, dyspnea, cyanosis, tachycardia, lacrimation, marked perspiration, flushing of the face, neck or upper chest, mild persistent clearing of the throat, hacking cough, or persistent sneezing.

1) Local Reactions

Small amounts of erythema and swelling at the site of injection are common, the extent varying with the patient. Such reactions should not be considered significant unless they persist for at least 24 hours or exceed 50 mm. in diameter.

Larger local reactions are not only uncomfortable, but also indicate the possibility of a systemic reaction if dosage is increased. In such cases the dosage should be reduced to the last level not causing the reaction and maintained at this level for two or three treatments before cautiously increasing again.

Large, persistent local reactions or minor exacerbations of the patient s allergic symptoms may be treated by local cold applications and/or the use of oral antihistamines, but they should be considered a warning of possible severe systemic reactions and the need for temporarily reduced dosages.

A mild burning immediately after the injection is to be expected; this usually leaves in 10 to 20 seconds. Prolonged pain, or pain radiating up the arm, is usually the result of intramuscular injection, making this injection route undesirable. Subcutaneous injection is the recommended route.

2) Systemic Reactions

With careful attention to dosage and administration, such reactions occur infrequentIy, but it must be remembered that allergenic extracts are highly potent to sensitive individuals and OVERDOSE could result in anaphylactic symptoms. Therefore, it is imperative that physicians administering allergenic extracts understand and be prepared for the treatment of severe reactions.

Adverse reaction frequency data for allergenic extract administration is not available. Inherent difficulties in establishing such data are the wide variations in clinical allergy types, patient sensitivity, treatment schedules used by allergists, potency of extracts from various sources, etc.

It cannot be overemphasized that, under certain unpredictable combinations of circumstances, anaphylactic shock is always a possibility. Other possible systemic reaction symptoms are, in varying degrees of severity, fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis, and urticaria.17,18

Overdosage 

If a systemic or anaphylactic reaction does occur, apply a tourniquet above the site of injection and inject intramuscularly or subcutaneously 0.3 to 0.5 ml of 1:1000 epinephrine-hydrochloride into the opposite arm. The dose may be repeated in 5-10 minutes if necessary. Loosen the tourniquet at least every 10 minutes.

The epinephrine HCL 1: 1000 dose for infants to 2 years is 0.05 to 0.1 ml; for children 2 to 6 years it is 0.15 ml; for children 6 to 12 years it is 0.2 ml.

Patients unresponsive to epinephrine may be treated with theophylline. Studies on asthmatic subjects reveal that plasma concentrations of theophylline of 5 to 20 ug/ml are associated with therapeutic effects. Toxicity is particularly apparent at concentrations greater than 20 ug/ml. A loading dose of aminophylline of 5.6 mg/kg intravenously followed by 0.9 mg/kg per hour results in plasma concentrations of approximately 10 ug/ml. (Mitenko and Ogilive 1973b; Nicholoson and Chick 1973).

Other beta-adrenergic drugs such as isoproterenol, isoetharine, or albuterol may be used by inhalation. The usual dose to relieve broncho-constriction in asthma is 0.5 ml or the 0.5% solution for isoproterenol HCL; albuterol is longer acting than isoproterenol by any route of administration. The albuterol inhaler delivers approximately 90 mcg of albuterol from the mouthpiece. The usual dosage for adults and children would be two inhalations repeated every 4 to 6 hours. Isoetharine supplied in the Bronkometer unit delivers approximately 340 mcg isoetharine. The average adult dose is one to two inhalations.

Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators. Respiratory obstruction not responding to parenteral or inhaled bronchodilators may require Theophylline, low-flow oxygen, intubation and the use of life support systems. Parenteral fluid and/or plasma expanders may be utilized for treatment of shock and low flow (two liters per minute) oxygen may be utilized if indicated. Adenocorticosteroids may be administered parenterally or intravenously. 8

How Supplied 

Individual treatment sets as prescribed by the physician. The allergenic extract contains a variable number of individual doses depending on the patient's sensitivity and maximum tolerated maintenance treatment dose.

References 

1. Baer, Harold E.: The Regulation of Allergenic Extracts by the U.S. Food and Drug Administration, Regulatory Control and Standardization of Allergenic Extracts, First International Paul-Ehrlich Seminar, May 20-22, 1979, Frankfurt, Germany, pp. 10-11.

2. Baer, Harold E.: Evaluation of RAST Inhibition, International Joint Steering Committee for Allergen Standardization, Course on Allergen Standardization, The Protein Laboratory, University of Copenhagen, August 4-9, 1980.

3. Baer, Harold E., L. Bolin, D. Levy, H. Lowenstein, & A. DeWeck: Standard reference extracts, (round table discussion), International Joint Steering Committee for Allergen Standardization, Course on Allergen Standardization. The Protein Laboratory, University of Copenhagen, August 4-9, 1980.

4. Baer, Harold E.: Second International Paul-Ehrlich Seminar on Regulatory Control and Standardization of Allergenic Extract, Frankfurt, Germany, September 13-15, 1981.

5. Evans, Richard, III and Summers, Richard: In vivo and in vitro tests to confirm clinical findings - Diagnostic tests for allergic patients. Journal of Respiratory Diseases, Vol. 65, No. 7, July 1981.

6. Fadal, Richard G. & Nalebuff, Donald J.: Tools of the Allergists: Old and New. Continuing Education for the Family Physician, Vol. 10, No. 5, May 1979, pp. 37-61.

7. Allergenic Products: Antigen E. Potency Test: Additional Standards for Miscellaneous Products, 21 CFR Part 680, Federal Register, Vol. 46, No. 147, Friday, July 31, 1981, Rules and Regulations, pp. 39128-39136.

8. Goodman, Louis S., Gillman, Alfred: Editors, The Pharmacological Basis of Therapeutics. MacMillan Publishing Co., Inc., Chapter 19, p. 375.

9. Kniker, William T.: Clinical Science and Common Sense in the Diagnosis and Immunotherapy of Respiratory Allergy. Continuing Education for the Family Physician, Vol. 10, No. 5, May 1979, pp. 16-33.

10. Matthews, Kenneth, et al: Rhinitis, Asthma and the Other Allergic Diseases, NIAID Task Force Report, U.S. Dept. HEW, NIH Publication No. 79-387, Chapter 4, pp. 213-217, May 1979.

11. Nalebuff, Donald J. and Fadal, Richard G.: The Modified RAST Assay: An Aid in the Diagnosis and Management of Allergic Disorders. Continuing Education for the Family Physician, Vol. 10, No. 5, May 1979, pp. 64-76.

12. Nelson, Harold S.: The Effect of Preservatives and Dilution on the Deterioration of Russian Thistle (Salsola pestifer), a pollen extract. The Journal of Allergy and Clinical Immunology. Vol. 63, No. 6, pp. 417-425, June 1979.

13. Norman, Philip S., Lichtenstein, L.M., Ishizaka, K.: Diagnostic tools in ragweed hay fever. A comparison of direct skin tests IgE antibody measurements and basophil histamine release. The Journal of Allergy and Clinical Immunology. Vol. 52, 1973, pp. 210.

14. Rocklin, Ross E., Sheffer, Albert L., Grainader, Dirk K., and Melmon, Kenneth: Generation of antigen-specific suppressor cells during allergy desensitization. New England Journal of Medicine, 302: May 29, 1980, pp. 1213-1219.

15. Seebohm, Paul M., et al: Panel on Review of Allergenic Extracts, Final Report, Food and Drug Administration, March 13, 1981, pp. 9-48.

16. Stevens, E.: Cutaneous Tests, Regulatory Control and Standardization of Allergenic Extracts, First International Paul-Ehrlich Seminar, May 20-22, 1979, Frankfurt, Germany, pp. 133-138.

17. Van Metre, Thomas E., Jr., Adkinson, N. Franklin, Jr., Amodio, Frank J., Lichtenstein, Lawrence L., Mardinay, Michael R., Jr., Norman, Philip S., Rosenberg, Gary L., Sobotka, Anne K., & Valentine, Martin D.: A comparative study of the effectiveness of the Rinkel method and the current standard method of immunology for ragweed pollen hay fever. The Journal of Clinical Allergy and Immunology, Vol. 66, No. 6, p. 511, December 1980.

18. Wasserman, S.: The mast cell and the inflammatory response, The Mast Cell - its role in health and disease. Edited by J. Pepys & A.M. Edwards, Proceedings of an International Symposium, Davos, Switzerland, Pitman Medical Publishing Co., 1979, pp. 9-20.

Container Labeling 

5 mL Treatment Set Label 10 mL Treatment Set Label
TREATMENT SET TS329678
treatment set ts329678 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0656
Route of Administration INTRADERMAL, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 10000 [AU] in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 1000 [BAU] in 1 mL
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 10000 [BAU] in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.005 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.005 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
GLYCERIN (UNII: PDC6A3C0OX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0656-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS333938
treatment set ts333938 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0657
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K) DERMATOPHAGOIDES PTERONYSSINUS 1000 [AU] in 1 mL
AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 0.00125 g in 1 mL
AMBROSIA BIDENTATA POLLEN (UNII: M3S672G75O) (AMBROSIA BIDENTATA POLLEN - UNII:M3S672G75O) AMBROSIA BIDENTATA POLLEN 0.00125 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 0.00125 g in 1 mL
AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (AMBROSIA PSILOSTACHYA POLLEN - UNII:RX18M46K8L) AMBROSIA PSILOSTACHYA POLLEN 0.00125 g in 1 mL
IVA XANTHIFOLIA POLLEN (UNII: V80TPZ0T6J) (IVA XANTHIFOLIA POLLEN - UNII:V80TPZ0T6J) IVA XANTHIFOLIA POLLEN 0.0025 g in 1 mL
IVA ANNUA VAR. ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA VAR. ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA VAR. ANNUA POLLEN 0.0025 g in 1 mL
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.005 g in 1 mL
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.005 g in 1 mL
FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4) (FAGUS GRANDIFOLIA POLLEN - UNII:34X886W1H4) FAGUS GRANDIFOLIA POLLEN 0.00021 g in 1 mL
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.00021 g in 1 mL
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.00021 g in 1 mL
SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 0.00021 g in 1 mL
CARPINUS CAROLINIANA POLLEN (UNII: 9UC4BM3IZ0) (CARPINUS CAROLINIANA POLLEN - UNII:9UC4BM3IZ0) CARPINUS CAROLINIANA POLLEN 0.00021 g in 1 mL
PICEA PUNGENS POLLEN (UNII: R9JBC6687X) (PICEA PUNGENS POLLEN - UNII:R9JBC6687X) PICEA PUNGENS POLLEN 0.00021 g in 1 mL
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.00021 g in 1 mL
PINUS STROBUS POLLEN (UNII: TX1ER5UV3T) (PINUS STROBUS POLLEN - UNII:TX1ER5UV3T) PINUS STROBUS POLLEN 0.00021 g in 1 mL
CELTIS OCCIDENTALIS POLLEN (UNII: 68R9X9Y96X) (CELTIS OCCIDENTALIS POLLEN - UNII:68R9X9Y96X) CELTIS OCCIDENTALIS POLLEN 0.00021 g in 1 mL
ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 0.00021 g in 1 mL
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.00021 g in 1 mL
BETULA PAPYRIFERA POLLEN (UNII: 3538FNV8AY) (BETULA PAPYRIFERA POLLEN - UNII:3538FNV8AY) BETULA PAPYRIFERA POLLEN 0.00021 g in 1 mL
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.00021 g in 1 mL
ACER RUBRUM POLLEN (UNII: 700NK45C76) (ACER RUBRUM POLLEN - UNII:700NK45C76) ACER RUBRUM POLLEN 0.00021 g in 1 mL
MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52) (MORUS RUBRA POLLEN - UNII:9LYI4RTZ52) MORUS RUBRA POLLEN 0.00021 g in 1 mL
JUNIPERUS PINCHOTII POLLEN (UNII: S8A4X05W7J) (JUNIPERUS PINCHOTII POLLEN - UNII:S8A4X05W7J) JUNIPERUS PINCHOTII POLLEN 0.00021 g in 1 mL
CARYA OVATA POLLEN (UNII: 54UN9R2798) (CARYA OVATA POLLEN - UNII:54UN9R2798) CARYA OVATA POLLEN 0.00021 g in 1 mL
ACER SACCHARINUM POLLEN (UNII: 95447163DG) (ACER SACCHARINUM POLLEN - UNII:95447163DG) ACER SACCHARINUM POLLEN 0.00021 g in 1 mL
LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (LIQUIDAMBAR STYRACIFLUA POLLEN - UNII:5Q246DS5BS) LIQUIDAMBAR STYRACIFLUA POLLEN 0.00021 g in 1 mL
AILANTHUS ALTISSIMA POLLEN (UNII: 2A64U81OQ3) (AILANTHUS ALTISSIMA POLLEN - UNII:2A64U81OQ3) AILANTHUS ALTISSIMA POLLEN 0.00021 g in 1 mL
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.00021 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.00021 g in 1 mL
MORUS ALBA POLLEN (UNII: 3I9T68187H) (MORUS ALBA POLLEN - UNII:3I9T68187H) MORUS ALBA POLLEN 0.00021 g in 1 mL
POPULUS ALBA POLLEN (UNII: VU8C8SB23P) (POPULUS ALBA POLLEN - UNII:VU8C8SB23P) POPULUS ALBA POLLEN 0.00021 g in 1 mL
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.001 g in 1 mL
ASPERGILLUS FLAVUS (UNII: 3J888Y9L13) (ASPERGILLUS FLAVUS - UNII:3J888Y9L13) ASPERGILLUS FLAVUS 0.00025 g in 1 mL
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.00025 g in 1 mL
ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 0.00025 g in 1 mL
ASPERGILLUS REPENS (UNII: SQ89E6LOME) (ASPERGILLUS REPENS - UNII:SQ89E6LOME) ASPERGILLUS REPENS 0.00025 g in 1 mL
FUSARIUM OXYSPORUM (UNII: 5398RXP8KU) (FUSARIUM OXYSPORUM - UNII:5398RXP8KU) FUSARIUM OXYSPORUM 0.001 g in 1 mL
COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 0.001 g in 1 mL
CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 0.001 g in 1 mL
MUCOR RACEMOSUS (UNII: 17RH99LQ7G) (MUCOR RACEMOSUS - UNII:17RH99LQ7G) MUCOR RACEMOSUS 0.001 g in 1 mL
PENICILLIUM CAMEMBERTI (UNII: T069R9OPVG) (PENICILLIUM CAMEMBERTI - UNII:T069R9OPVG) PENICILLIUM CAMEMBERTI 0.00017 g in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.00017 g in 1 mL
PENICILLIUM EXPANSUM (UNII: 1XSC3BB35Z) (PENICILLIUM EXPANSUM - UNII:1XSC3BB35Z) PENICILLIUM EXPANSUM 0.00017 g in 1 mL
PENICILLIUM ITALICUM (UNII: AZJ5XKM7W3) (PENICILLIUM ITALICUM - UNII:AZJ5XKM7W3) PENICILLIUM ITALICUM 0.00017 g in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.00017 g in 1 mL
PENICILLIUM ROQUEFORTI (UNII: 7ORP6R724L) (PENICILLIUM ROQUEFORTI - UNII:7ORP6R724L) PENICILLIUM ROQUEFORTI 0.00017 g in 1 mL
PHOMA DESTRUCTIVA (UNII: A17SE577FM) (PHOMA DESTRUCTIVA - UNII:A17SE577FM) PHOMA DESTRUCTIVA 0.001 g in 1 mL
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.001 g in 1 mL
RHIZOPUS STOLONIFER (UNII: FEE198DK4Q) (RHIZOPUS STOLONIFER - UNII:FEE198DK4Q) RHIZOPUS STOLONIFER 0.001 g in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 45.5 [BAU] in 1 mL
LOLIUM PERENNE POLLEN (UNII: 4T81LB52R0) (LOLIUM PERENNE POLLEN - UNII:4T81LB52R0) LOLIUM PERENNE POLLEN 454.5 [BAU] in 1 mL
AGROSTIS GIGANTEA POLLEN (UNII: HU8V6E7HOA) (AGROSTIS GIGANTEA POLLEN - UNII:HU8V6E7HOA) AGROSTIS GIGANTEA POLLEN 454.5 [BAU] in 1 mL
DACTYLIS GLOMERATA POLLEN (UNII: 83N78IDA7P) (DACTYLIS GLOMERATA POLLEN - UNII:83N78IDA7P) DACTYLIS GLOMERATA POLLEN 454.5 [BAU] in 1 mL
PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG) PHLEUM PRATENSE POLLEN 454.5 [BAU] in 1 mL
FESTUCA PRATENSIS POLLEN (UNII: A0WFQ8P6N1) (FESTUCA PRATENSIS POLLEN - UNII:A0WFQ8P6N1) FESTUCA PRATENSIS POLLEN 454.5 [BAU] in 1 mL
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 454.5 [BAU] in 1 mL
ANTHOXANTHUM ODORATUM POLLEN (UNII: 2KIK19R45Y) (ANTHOXANTHUM ODORATUM POLLEN - UNII:2KIK19R45Y) ANTHOXANTHUM ODORATUM POLLEN 454.5 [BAU] in 1 mL
POA COMPRESSA POLLEN (UNII: 50HCQ1NYV5) (POA COMPRESSA POLLEN - UNII:50HCQ1NYV5) POA COMPRESSA POLLEN 0.000227 g in 1 mL
TYPHA LATIFOLIA POLLEN (UNII: 341PDX5PLM) (TYPHA LATIFOLIA POLLEN - UNII:341PDX5PLM) TYPHA LATIFOLIA POLLEN 0.000227 g in 1 mL
BROMUS SECALINUS POLLEN (UNII: Q4T1SJ3046) (BROMUS SECALINUS POLLEN - UNII:Q4T1SJ3046) BROMUS SECALINUS POLLEN 0.000227 g in 1 mL
ZEA MAYS POLLEN (UNII: 74PD8J616H) (ZEA MAYS POLLEN - UNII:74PD8J616H) ZEA MAYS POLLEN 0.000227 g in 1 mL
SECALE CEREALE POLLEN (UNII: I6KAZ8AO1O) (SECALE CEREALE POLLEN - UNII:I6KAZ8AO1O) SECALE CEREALE POLLEN 0.000227 g in 1 mL
TRITICUM AESTIVUM POLLEN (UNII: F1KAH8374D) (TRITICUM AESTIVUM POLLEN - UNII:F1KAH8374D) TRITICUM AESTIVUM POLLEN 0.000227 g in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.000227 g in 1 mL
ELYMUS REPENS POLLEN (UNII: ON2T85TA2O) (ELYMUS REPENS POLLEN - UNII:ON2T85TA2O) ELYMUS REPENS POLLEN 0.000227 g in 1 mL
PHALARIS ARUNDINACEA POLLEN (UNII: FAY1Y90VJ9) (PHALARIS ARUNDINACEA POLLEN - UNII:FAY1Y90VJ9) PHALARIS ARUNDINACEA POLLEN 0.000227 g in 1 mL
BROMUS INERMIS POLLEN (UNII: 766QT72BK6) (BROMUS INERMIS POLLEN - UNII:766QT72BK6) BROMUS INERMIS POLLEN 0.000227 g in 1 mL
SORGHUM BICOLOR SSP. DRUMMONDII POLLEN (UNII: B43R30VP73) (SORGHUM BICOLOR SSP. DRUMMONDII POLLEN - UNII:B43R30VP73) SORGHUM BICOLOR SSP. DRUMMONDII POLLEN 0.000227 g in 1 mL
ARRHENATHERUM ELATIUS POLLEN (UNII: B55BD1QM4Q) (ARRHENATHERUM ELATIUS POLLEN - UNII:B55BD1QM4Q) ARRHENATHERUM ELATIUS POLLEN 0.000227 g in 1 mL
HOLCUS LANATUS POLLEN (UNII: 70O1TP6H01) (HOLCUS LANATUS POLLEN - UNII:70O1TP6H01) HOLCUS LANATUS POLLEN 0.000227 g in 1 mL
PASCOPYRUM SMITHII POLLEN (UNII: 6AU0ZD8T1O) (PASCOPYRUM SMITHII POLLEN - UNII:6AU0ZD8T1O) PASCOPYRUM SMITHII POLLEN 0.000227 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
PHENOL (UNII: 339NCG44TV)
GLYCERIN (UNII: PDC6A3C0OX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0657-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS128872
treatment set ts128872 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0658
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 0.00125 g in 1 mL
AMBROSIA BIDENTATA POLLEN (UNII: M3S672G75O) (AMBROSIA BIDENTATA POLLEN - UNII:M3S672G75O) AMBROSIA BIDENTATA POLLEN 0.00125 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 0.00125 g in 1 mL
AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (AMBROSIA PSILOSTACHYA POLLEN - UNII:RX18M46K8L) AMBROSIA PSILOSTACHYA POLLEN 0.00125 g in 1 mL
AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH) (AMARANTHUS PALMERI POLLEN - UNII:1GH3WV23KH) AMARANTHUS PALMERI POLLEN 0.00125 g in 1 mL
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.00125 g in 1 mL
AMARANTHUS SPINOSUS POLLEN (UNII: 380W4HYR6N) (AMARANTHUS SPINOSUS POLLEN - UNII:380W4HYR6N) AMARANTHUS SPINOSUS POLLEN 0.00125 g in 1 mL
AMARANTHUS TUBERCULATUS POLLEN (UNII: 92N6W6KO2G) (AMARANTHUS TUBERCULATUS POLLEN - UNII:92N6W6KO2G) AMARANTHUS TUBERCULATUS POLLEN 0.00125 g in 1 mL
KOCHIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (KOCHIA SCOPARIA POLLEN - UNII:07A108ZKW5) KOCHIA SCOPARIA POLLEN 0.005 g in 1 mL
FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4) (FAGUS GRANDIFOLIA POLLEN - UNII:34X886W1H4) FAGUS GRANDIFOLIA POLLEN 0.00021 g in 1 mL
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.00021 g in 1 mL
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.00021 g in 1 mL
SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 0.00021 g in 1 mL
CARPINUS CAROLINIANA POLLEN (UNII: 9UC4BM3IZ0) (CARPINUS CAROLINIANA POLLEN - UNII:9UC4BM3IZ0) CARPINUS CAROLINIANA POLLEN 0.00021 g in 1 mL
PICEA PUNGENS POLLEN (UNII: R9JBC6687X) (PICEA PUNGENS POLLEN - UNII:R9JBC6687X) PICEA PUNGENS POLLEN 0.00021 g in 1 mL
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.00021 g in 1 mL
PINUS STROBUS POLLEN (UNII: TX1ER5UV3T) (PINUS STROBUS POLLEN - UNII:TX1ER5UV3T) PINUS STROBUS POLLEN 0.00021 g in 1 mL
CELTIS OCCIDENTALIS POLLEN (UNII: 68R9X9Y96X) (CELTIS OCCIDENTALIS POLLEN - UNII:68R9X9Y96X) CELTIS OCCIDENTALIS POLLEN 0.00021 g in 1 mL
ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 0.00021 g in 1 mL
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.00021 g in 1 mL
BETULA PAPYRIFERA POLLEN (UNII: 3538FNV8AY) (BETULA PAPYRIFERA POLLEN - UNII:3538FNV8AY) BETULA PAPYRIFERA POLLEN 0.00021 g in 1 mL
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.00021 g in 1 mL
ACER RUBRUM POLLEN (UNII: 700NK45C76) (ACER RUBRUM POLLEN - UNII:700NK45C76) ACER RUBRUM POLLEN 0.00021 g in 1 mL
MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52) (MORUS RUBRA POLLEN - UNII:9LYI4RTZ52) MORUS RUBRA POLLEN 0.00021 g in 1 mL
JUNIPERUS PINCHOTII POLLEN (UNII: S8A4X05W7J) (JUNIPERUS PINCHOTII POLLEN - UNII:S8A4X05W7J) JUNIPERUS PINCHOTII POLLEN 0.00021 g in 1 mL
CARYA OVATA POLLEN (UNII: 54UN9R2798) (CARYA OVATA POLLEN - UNII:54UN9R2798) CARYA OVATA POLLEN 0.00021 g in 1 mL
ACER SACCHARINUM POLLEN (UNII: 95447163DG) (ACER SACCHARINUM POLLEN - UNII:95447163DG) ACER SACCHARINUM POLLEN 0.00021 g in 1 mL
LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (LIQUIDAMBAR STYRACIFLUA POLLEN - UNII:5Q246DS5BS) LIQUIDAMBAR STYRACIFLUA POLLEN 0.00021 g in 1 mL
AILANTHUS ALTISSIMA POLLEN (UNII: 2A64U81OQ3) (AILANTHUS ALTISSIMA POLLEN - UNII:2A64U81OQ3) AILANTHUS ALTISSIMA POLLEN 0.00021 g in 1 mL
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.00021 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.00021 g in 1 mL
MORUS ALBA POLLEN (UNII: 3I9T68187H) (MORUS ALBA POLLEN - UNII:3I9T68187H) MORUS ALBA POLLEN 0.00021 g in 1 mL
POPULUS ALBA POLLEN (UNII: VU8C8SB23P) (POPULUS ALBA POLLEN - UNII:VU8C8SB23P) POPULUS ALBA POLLEN 0.00021 g in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 1045.5 [BAU] in 1 mL
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 454.5 [BAU] in 1 mL
FESTUCA PRATENSIS POLLEN (UNII: A0WFQ8P6N1) (FESTUCA PRATENSIS POLLEN - UNII:A0WFQ8P6N1) FESTUCA PRATENSIS POLLEN 454.5 [BAU] in 1 mL
DACTYLIS GLOMERATA POLLEN (UNII: 83N78IDA7P) (DACTYLIS GLOMERATA POLLEN - UNII:83N78IDA7P) DACTYLIS GLOMERATA POLLEN 454.5 [BAU] in 1 mL
LOLIUM PERENNE POLLEN (UNII: 4T81LB52R0) (LOLIUM PERENNE POLLEN - UNII:4T81LB52R0) LOLIUM PERENNE POLLEN 454.5 [BAU] in 1 mL
AGROSTIS GIGANTEA POLLEN (UNII: HU8V6E7HOA) (AGROSTIS GIGANTEA POLLEN - UNII:HU8V6E7HOA) AGROSTIS GIGANTEA POLLEN 454.5 [BAU] in 1 mL
ANTHOXANTHUM ODORATUM POLLEN (UNII: 2KIK19R45Y) (ANTHOXANTHUM ODORATUM POLLEN - UNII:2KIK19R45Y) ANTHOXANTHUM ODORATUM POLLEN 454.5 [BAU] in 1 mL
PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG) PHLEUM PRATENSE POLLEN 454.5 [BAU] in 1 mL
POA COMPRESSA POLLEN (UNII: 50HCQ1NYV5) (POA COMPRESSA POLLEN - UNII:50HCQ1NYV5) POA COMPRESSA POLLEN 0.000227 g in 1 mL
TYPHA LATIFOLIA POLLEN (UNII: 341PDX5PLM) (TYPHA LATIFOLIA POLLEN - UNII:341PDX5PLM) TYPHA LATIFOLIA POLLEN 0.000227 g in 1 mL
BROMUS SECALINUS POLLEN (UNII: Q4T1SJ3046) (BROMUS SECALINUS POLLEN - UNII:Q4T1SJ3046) BROMUS SECALINUS POLLEN 0.000227 g in 1 mL
ZEA MAYS POLLEN (UNII: 74PD8J616H) (ZEA MAYS POLLEN - UNII:74PD8J616H) ZEA MAYS POLLEN 0.000227 g in 1 mL
SECALE CEREALE POLLEN (UNII: I6KAZ8AO1O) (SECALE CEREALE POLLEN - UNII:I6KAZ8AO1O) SECALE CEREALE POLLEN 0.000227 g in 1 mL
TRITICUM AESTIVUM POLLEN (UNII: F1KAH8374D) (TRITICUM AESTIVUM POLLEN - UNII:F1KAH8374D) TRITICUM AESTIVUM POLLEN 0.000227 g in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.000227 g in 1 mL
ELYMUS REPENS POLLEN (UNII: ON2T85TA2O) (ELYMUS REPENS POLLEN - UNII:ON2T85TA2O) ELYMUS REPENS POLLEN 0.000227 g in 1 mL
PHALARIS ARUNDINACEA POLLEN (UNII: FAY1Y90VJ9) (PHALARIS ARUNDINACEA POLLEN - UNII:FAY1Y90VJ9) PHALARIS ARUNDINACEA POLLEN 0.000227 g in 1 mL
BROMUS INERMIS POLLEN (UNII: 766QT72BK6) (BROMUS INERMIS POLLEN - UNII:766QT72BK6) BROMUS INERMIS POLLEN 0.000227 g in 1 mL
SORGHUM BICOLOR SSP. DRUMMONDII POLLEN (UNII: B43R30VP73) (SORGHUM BICOLOR SSP. DRUMMONDII POLLEN - UNII:B43R30VP73) SORGHUM BICOLOR SSP. DRUMMONDII POLLEN 0.000227 g in 1 mL
ARRHENATHERUM ELATIUS POLLEN (UNII: B55BD1QM4Q) (ARRHENATHERUM ELATIUS POLLEN - UNII:B55BD1QM4Q) ARRHENATHERUM ELATIUS POLLEN 0.000227 g in 1 mL
HOLCUS LANATUS POLLEN (UNII: 70O1TP6H01) (HOLCUS LANATUS POLLEN - UNII:70O1TP6H01) HOLCUS LANATUS POLLEN 0.000227 g in 1 mL
PASCOPYRUM SMITHII POLLEN (UNII: 6AU0ZD8T1O) (PASCOPYRUM SMITHII POLLEN - UNII:6AU0ZD8T1O) PASCOPYRUM SMITHII POLLEN 0.000227 g in 1 mL
ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (ARTEMISIA VULGARIS POLLEN - UNII:ANT994T71D) ARTEMISIA VULGARIS POLLEN 0.00125 g in 1 mL
ARTEMISIA ABSINTHIUM POLLEN (UNII: 81GS97HVFO) (ARTEMISIA ABSINTHIUM POLLEN - UNII:81GS97HVFO) ARTEMISIA ABSINTHIUM POLLEN 0.00125 g in 1 mL
ARTEMISIA TRIDENTATA POLLEN (UNII: YI19RB8YFD) (ARTEMISIA TRIDENTATA POLLEN - UNII:YI19RB8YFD) ARTEMISIA TRIDENTATA POLLEN 0.00125 g in 1 mL
ARTEMISIA LUDOVICIANA POLLEN (UNII: 57KIJ4772H) (ARTEMISIA LUDOVICIANA POLLEN - UNII:57KIJ4772H) ARTEMISIA LUDOVICIANA POLLEN 0.00125 g in 1 mL
IVA XANTHIFOLIA POLLEN (UNII: V80TPZ0T6J) (IVA XANTHIFOLIA POLLEN - UNII:V80TPZ0T6J) IVA XANTHIFOLIA POLLEN 0.0025 g in 1 mL
IVA ANNUA VAR. ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA VAR. ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA VAR. ANNUA POLLEN 0.0025 g in 1 mL
RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (RUMEX CRISPUS POLLEN - UNII:V825XJG64G) RUMEX CRISPUS POLLEN 0.0025 g in 1 mL
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.0025 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
GLYCERIN (UNII: PDC6A3C0OX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0658-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS128871
treatment set ts128871 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0659
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 0.005 g in 1 mL
ACREMONIUM STRICTUM (UNII: 3F36V0451W) (ACREMONIUM STRICTUM - UNII:3F36V0451W) ACREMONIUM STRICTUM 0.005 g in 1 mL
TRICHOTHECIUM ROSEUM (UNII: TGO054E31O) (TRICHOTHECIUM ROSEUM - UNII:TGO054E31O) TRICHOTHECIUM ROSEUM 0.00036 g in 1 mL
PASSALORA FULVA (UNII: HR6H5057CO) (PASSALORA FULVA - UNII:HR6H5057CO) PASSALORA FULVA 0.00036 g in 1 mL
COCHLIOBOLUS SPICIFER (UNII: 91M9RWP3TD) (COCHLIOBOLUS SPICIFER - UNII:91M9RWP3TD) COCHLIOBOLUS SPICIFER 0.00036 g in 1 mL
MYROTHECIUM VERRUCARIA (UNII: W5U19AK212) (MYROTHECIUM VERRUCARIA - UNII:W5U19AK212) MYROTHECIUM VERRUCARIA 0.00036 g in 1 mL
HYPOMYCES PERNICIOSUS (UNII: 6K41G30A6U) (HYPOMYCES PERNICIOSUS - UNII:6K41G30A6U) HYPOMYCES PERNICIOSUS 0.00036 g in 1 mL
NEUROSPORA CRASSA (UNII: 1X92VM01YP) (NEUROSPORA CRASSA - UNII:1X92VM01YP) NEUROSPORA CRASSA 0.00036 g in 1 mL
KHUSKIA ORYZAE (UNII: VK8C112WTS) (KHUSKIA ORYZAE - UNII:VK8C112WTS) KHUSKIA ORYZAE 0.00036 g in 1 mL
PAECILOMYCES VARIOTII (UNII: KO7V58BY40) (PAECILOMYCES VARIOTII - UNII:KO7V58BY40) PAECILOMYCES VARIOTII 0.00036 g in 1 mL
MICROASCUS BREVICAULIS (UNII: DHI513VXU7) (MICROASCUS BREVICAULIS - UNII:DHI513VXU7) MICROASCUS BREVICAULIS 0.00036 g in 1 mL
COLLETOTRICHUM COCCODES (UNII: Y0M7LGE3Z8) (COLLETOTRICHUM COCCODES - UNII:Y0M7LGE3Z8) COLLETOTRICHUM COCCODES 0.00036 g in 1 mL
PLEOSPORA HERBARUM (UNII: 0N3Z1P4B2W) (PLEOSPORA HERBARUM - UNII:0N3Z1P4B2W) PLEOSPORA HERBARUM 0.00036 g in 1 mL
STREPTOMYCES GRISEUS (UNII: G0O5980Z7W) (STREPTOMYCES GRISEUS - UNII:G0O5980Z7W) STREPTOMYCES GRISEUS 0.00036 g in 1 mL
TRICHODERMA VIRIDE (UNII: T8678F0P0Q) (TRICHODERMA VIRIDE - UNII:T8678F0P0Q) TRICHODERMA VIRIDE 0.00036 g in 1 mL
TRICHOPHYTON SCHOENLEINII (UNII: Z4MD1809H1) (TRICHOPHYTON SCHOENLEINII - UNII:Z4MD1809H1) TRICHOPHYTON SCHOENLEINII 0.00036 g in 1 mL
MYCOCLADUS CORYMBIFERUS (UNII: 1M4E76V32I) (MYCOCLADUS CORYMBIFERUS - UNII:1M4E76V32I) MYCOCLADUS CORYMBIFERUS 0.00042 g in 1 mL
ACROTHECIUM ROBUSTUM (UNII: C91ZMT66YA) (ACROTHECIUM ROBUSTUM - UNII:C91ZMT66YA) ACROTHECIUM ROBUSTUM 0.00042 g in 1 mL
HUMICOLA GRISEA (UNII: RZ55S3AQOJ) (HUMICOLA GRISEA - UNII:RZ55S3AQOJ) HUMICOLA GRISEA 0.00042 g in 1 mL
MICROSPORUM AUDOUINII (UNII: B7B86Y84R8) (MICROSPORUM AUDOUINII - UNII:B7B86Y84R8) MICROSPORUM AUDOUINII 0.00042 g in 1 mL
MICROSPORUM CANIS (UNII: N4F4RQ7BY7) (MICROSPORUM CANIS - UNII:N4F4RQ7BY7) MICROSPORUM CANIS 0.00042 g in 1 mL
APIOSPORA MONTAGNEI (UNII: 49VI1ZSO06) (APIOSPORA MONTAGNEI - UNII:49VI1ZSO06) APIOSPORA MONTAGNEI 0.00042 g in 1 mL
PHYCOMYCES BLAKESLEEANUS (UNII: 41Y752Y34M) (PHYCOMYCES BLAKESLEEANUS - UNII:41Y752Y34M) PHYCOMYCES BLAKESLEEANUS 0.00042 g in 1 mL
SPOROTRICHUM PRUINOSUM (UNII: H20KU95UBG) (SPOROTRICHUM PRUINOSUM - UNII:H20KU95UBG) SPOROTRICHUM PRUINOSUM 0.00042 g in 1 mL
STACHYBOTRYS CHARTARUM (UNII: HJ4L70T1ZP) (STACHYBOTRYS CHARTARUM - UNII:HJ4L70T1ZP) STACHYBOTRYS CHARTARUM 0.00042 g in 1 mL
SYNCEPHALASTRUM RACEMOSUM (UNII: 2VWV12V9WR) (SYNCEPHALASTRUM RACEMOSUM - UNII:2VWV12V9WR) SYNCEPHALASTRUM RACEMOSUM 0.00042 g in 1 mL
TETRACOCCOSPORIUM PAXIANUM (UNII: KSY1AWN59I) (TETRACOCCOSPORIUM PAXIANUM - UNII:KSY1AWN59I) TETRACOCCOSPORIUM PAXIANUM 0.00042 g in 1 mL
VERTICILLIUM ALBO-ATRUM (UNII: X92O101CS2) (VERTICILLIUM ALBO-ATRUM - UNII:X92O101CS2) VERTICILLIUM ALBO-ATRUM 0.00042 g in 1 mL
USTILAGO CYNODONTIS (UNII: 0V3J4YEX2W) (USTILAGO CYNODONTIS - UNII:0V3J4YEX2W) USTILAGO CYNODONTIS 0.0025 g in 1 mL
SPORISORIUM CRUENTUM (UNII: GQM6LVU5V8) (SPORISORIUM CRUENTUM - UNII:GQM6LVU5V8) SPORISORIUM CRUENTUM 0.0025 g in 1 mL
CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR) CANIS LUPUS FAMILIARIS HAIR 0.005 g in 1 mL
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 500 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0659-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS128873
treatment set ts128873 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0660
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 0.00125 g in 1 mL
AMBROSIA BIDENTATA POLLEN (UNII: M3S672G75O) (AMBROSIA BIDENTATA POLLEN - UNII:M3S672G75O) AMBROSIA BIDENTATA POLLEN 0.00125 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 0.00125 g in 1 mL
AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (AMBROSIA PSILOSTACHYA POLLEN - UNII:RX18M46K8L) AMBROSIA PSILOSTACHYA POLLEN 0.00125 g in 1 mL
AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH) (AMARANTHUS PALMERI POLLEN - UNII:1GH3WV23KH) AMARANTHUS PALMERI POLLEN 0.00125 g in 1 mL
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.00125 g in 1 mL
AMARANTHUS SPINOSUS POLLEN (UNII: 380W4HYR6N) (AMARANTHUS SPINOSUS POLLEN - UNII:380W4HYR6N) AMARANTHUS SPINOSUS POLLEN 0.00125 g in 1 mL
AMARANTHUS TUBERCULATUS POLLEN (UNII: 92N6W6KO2G) (AMARANTHUS TUBERCULATUS POLLEN - UNII:92N6W6KO2G) AMARANTHUS TUBERCULATUS POLLEN 0.00125 g in 1 mL
KOCHIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (KOCHIA SCOPARIA POLLEN - UNII:07A108ZKW5) KOCHIA SCOPARIA POLLEN 0.005 g in 1 mL
CHENOPODIUM BOTRYS POLLEN (UNII: IVU789297D) (CHENOPODIUM BOTRYS POLLEN - UNII:IVU789297D) CHENOPODIUM BOTRYS POLLEN 0.00167 g in 1 mL
CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 0.00167 g in 1 mL
CHENOPODIUM AMBROSIOIDES POLLEN (UNII: WIB701MW2H) (CHENOPODIUM AMBROSIOIDES POLLEN - UNII:WIB701MW2H) CHENOPODIUM AMBROSIOIDES POLLEN 0.00167 g in 1 mL
IVA XANTHIFOLIA POLLEN (UNII: V80TPZ0T6J) (IVA XANTHIFOLIA POLLEN - UNII:V80TPZ0T6J) IVA XANTHIFOLIA POLLEN 0.0025 g in 1 mL
IVA ANNUA VAR. ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA VAR. ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA VAR. ANNUA POLLEN 0.0025 g in 1 mL
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.005 g in 1 mL
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.005 g in 1 mL
RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (RUMEX CRISPUS POLLEN - UNII:V825XJG64G) RUMEX CRISPUS POLLEN 0.0025 g in 1 mL
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.0025 g in 1 mL
FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4) (FAGUS GRANDIFOLIA POLLEN - UNII:34X886W1H4) FAGUS GRANDIFOLIA POLLEN 0.00021 g in 1 mL
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.00021 g in 1 mL
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.00021 g in 1 mL
SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 0.00021 g in 1 mL
CARPINUS CAROLINIANA POLLEN (UNII: 9UC4BM3IZ0) (CARPINUS CAROLINIANA POLLEN - UNII:9UC4BM3IZ0) CARPINUS CAROLINIANA POLLEN 0.00021 g in 1 mL
PICEA PUNGENS POLLEN (UNII: R9JBC6687X) (PICEA PUNGENS POLLEN - UNII:R9JBC6687X) PICEA PUNGENS POLLEN 0.00021 g in 1 mL
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.00021 g in 1 mL
PINUS STROBUS POLLEN (UNII: TX1ER5UV3T) (PINUS STROBUS POLLEN - UNII:TX1ER5UV3T) PINUS STROBUS POLLEN 0.00021 g in 1 mL
CELTIS OCCIDENTALIS POLLEN (UNII: 68R9X9Y96X) (CELTIS OCCIDENTALIS POLLEN - UNII:68R9X9Y96X) CELTIS OCCIDENTALIS POLLEN 0.00021 g in 1 mL
ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 0.00021 g in 1 mL
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.00021 g in 1 mL
BETULA PAPYRIFERA POLLEN (UNII: 3538FNV8AY) (BETULA PAPYRIFERA POLLEN - UNII:3538FNV8AY) BETULA PAPYRIFERA POLLEN 0.00021 g in 1 mL
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.00021 g in 1 mL
ACER RUBRUM POLLEN (UNII: 700NK45C76) (ACER RUBRUM POLLEN - UNII:700NK45C76) ACER RUBRUM POLLEN 0.00021 g in 1 mL
MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52) (MORUS RUBRA POLLEN - UNII:9LYI4RTZ52) MORUS RUBRA POLLEN 0.00021 g in 1 mL
JUNIPERUS PINCHOTII POLLEN (UNII: S8A4X05W7J) (JUNIPERUS PINCHOTII POLLEN - UNII:S8A4X05W7J) JUNIPERUS PINCHOTII POLLEN 0.00021 g in 1 mL
CARYA OVATA POLLEN (UNII: 54UN9R2798) (CARYA OVATA POLLEN - UNII:54UN9R2798) CARYA OVATA POLLEN 0.00021 g in 1 mL
ACER SACCHARINUM POLLEN (UNII: 95447163DG) (ACER SACCHARINUM POLLEN - UNII:95447163DG) ACER SACCHARINUM POLLEN 0.00021 g in 1 mL
LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (LIQUIDAMBAR STYRACIFLUA POLLEN - UNII:5Q246DS5BS) LIQUIDAMBAR STYRACIFLUA POLLEN 0.00021 g in 1 mL
AILANTHUS ALTISSIMA POLLEN (UNII: 2A64U81OQ3) (AILANTHUS ALTISSIMA POLLEN - UNII:2A64U81OQ3) AILANTHUS ALTISSIMA POLLEN 0.00021 g in 1 mL
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.00021 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.00021 g in 1 mL
MORUS ALBA POLLEN (UNII: 3I9T68187H) (MORUS ALBA POLLEN - UNII:3I9T68187H) MORUS ALBA POLLEN 0.00021 g in 1 mL
POPULUS ALBA POLLEN (UNII: VU8C8SB23P) (POPULUS ALBA POLLEN - UNII:VU8C8SB23P) POPULUS ALBA POLLEN 0.00021 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0660-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS128870
treatment set ts128870 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0661
Route of Administration INTRADERMAL, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.005 g in 1 mL
EQUUS CABALLUS HAIR (UNII: 4F35XG0149) (EQUUS CABALLUS HAIR - UNII:4F35XG0149) EQUUS CABALLUS HAIR 0.005 g in 1 mL
DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K) DERMATOPHAGOIDES PTERONYSSINUS 300 [AU] in 1 mL
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 500 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0661-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS330718
treatment set ts330718 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0662
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K) DERMATOPHAGOIDES PTERONYSSINUS 80 [AU] in 1 mL
DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q) DERMATOPHAGOIDES FARINAE 80 [AU] in 1 mL
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 16 [BAU] in 1 mL
CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR) CANIS LUPUS FAMILIARIS HAIR 0.00008 g in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 80 [BAU] in 1 mL
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 4000 [BAU] in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.002 g in 1 mL
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 0.0004 g in 1 mL
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.002 g in 1 mL
MUCOR RACEMOSUS (UNII: 17RH99LQ7G) (MUCOR RACEMOSUS - UNII:17RH99LQ7G) MUCOR RACEMOSUS 0.002 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.002 g in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.002 g in 1 mL
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.002 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.002 g in 1 mL
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.002 g in 1 mL
MORUS ALBA POLLEN (UNII: 3I9T68187H) (MORUS ALBA POLLEN - UNII:3I9T68187H) MORUS ALBA POLLEN 0.002 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 800 [AU] in 1 mL
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.002 g in 1 mL
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.002 g in 1 mL
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.002 g in 1 mL
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.002 g in 1 mL
URTICA DIOICA POLLEN (UNII: DNB59M1NVU) (URTICA DIOICA POLLEN - UNII:DNB59M1NVU) URTICA DIOICA POLLEN 0.002 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0662-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS333400
treatment set ts333400 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0663
Route of Administration INTRADERMAL, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 2000 [BAU] in 1 mL
CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR) CANIS LUPUS FAMILIARIS HAIR 0.01 g in 1 mL
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.01 g in 1 mL
PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG) PHLEUM PRATENSE POLLEN 20000 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0663-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS331884
treatment set ts331884 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0664
Route of Administration INTRADERMAL, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K) DERMATOPHAGOIDES PTERONYSSINUS 2000 [AU] in 1 mL
DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q) DERMATOPHAGOIDES FARINAE 2000 [AU] in 1 mL
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 0.01 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0664-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS331413
treatment set ts331413 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0665
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG) PHLEUM PRATENSE POLLEN 800 [BAU] in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 1000 [BAU] in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 10000 [AU] in 1 mL
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.005 g in 1 mL
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.005 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.005 g in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.005 g in 1 mL
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.002 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.002 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0665-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS333541
treatment set ts333541 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0666
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 2000 [BAU] in 1 mL
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.01 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 20000 [AU] in 1 mL
IVA ANNUA VAR. ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA VAR. ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA VAR. ANNUA POLLEN 0.01 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0666-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS333312
treatment set ts333312 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0667
Route of Administration INTRADERMAL, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.002 g in 1 mL
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.01 g in 1 mL
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.01 g in 1 mL
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.01 g in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 80 [BAU] in 1 mL
PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG) PHLEUM PRATENSE POLLEN 800 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0667-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 12/18/2009
TREATMENT SET TS332975
treatment set ts332975 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0668
Route of Administration INTRADERMAL, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 400 [BAU] in 1 mL
CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR) CANIS LUPUS FAMILIARIS HAIR 0.01 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0668-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 12/18/2009
TREATMENT SET TS333635
treatment set ts333635 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0669
Route of Administration SUBCUTANEOUS, INTRADERMAL
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 0.005 g in 1 mL
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.005 g in 1 mL
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.005 g in 1 mL
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.005 g in 1 mL
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.005 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.002 [Amb'a'1'U] in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.005 g in 1 mL
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.005 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.005 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 10000 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0669-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 12/18/2009
TREATMENT SET TS332406
treatment set ts332406 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0670
Route of Administration INTRADERMAL, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q) DERMATOPHAGOIDES FARINAE 400 [AU] in 1 mL
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 0.002 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 4000 [AU] in 1 mL
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.002 g in 1 mL
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.002 g in 1 mL
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.002 g in 1 mL
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.002 g in 1 mL
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.002 g in 1 mL
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.002 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.002 g in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.002 g in 1 mL
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.002 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.002 g in 1 mL
MORUS ALBA POLLEN (UNII: 3I9T68187H) (MORUS ALBA POLLEN - UNII:3I9T68187H) MORUS ALBA POLLEN 0.002 g in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 400 [BAU] in 1 mL
PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG) PHLEUM PRATENSE POLLEN 4000 g in 1 mL
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.002 g in 1 mL
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.002 g in 1 mL
IVA ANNUA VAR. ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA VAR. ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA VAR. ANNUA POLLEN 0.002 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0670-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 12/18/2009
TREATMENT SET TS332499
treatment set ts332499 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0671
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.002 g in 1 mL
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.002 g in 1 mL
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 400 [BAU] in 1 mL
CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR) CANIS LUPUS FAMILIARIS HAIR 0.002 g in 1 mL
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.002 g in 1 mL
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.002 g in 1 mL
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.002 g in 1 mL
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.002 g in 1 mL
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.002 g in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.002 g in 1 mL
PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG) PHLEUM PRATENSE POLLEN 4000 [BAU] in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 4000 [AU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
GLYCERIN (UNII: PDC6A3C0OX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0671-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS332229
treatment set ts332229 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0672
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K) DERMATOPHAGOIDES PTERONYSSINUS 400 [AU] in 1 mL
DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q) DERMATOPHAGOIDES FARINAE 400 g in 1 mL
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.002 g in 1 mL
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.0004 g in 1 mL
CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR) CANIS LUPUS FAMILIARIS HAIR 0.002 g in 1 mL
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 0.002 g in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.002 g in 1 mL
CLADOSPORIUM HERBARUM (UNII: O64JF11198) (CLADOSPORIUM HERBARUM - UNII:O64JF11198) CLADOSPORIUM HERBARUM 0.002 g in 1 mL
PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE - UNII:S7PW24BX20) PHLEUM PRATENSE POLLEN 4000 [BAU] in 1 mL
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.002 g in 1 mL
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.002 g in 1 mL
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.002 g in 1 mL
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.002 g in 1 mL
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.002 g in 1 mL
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.002 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.002 g in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.002 g in 1 mL
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.001 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.001 g in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 400 [BAU] in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 4000 [AU] in 1 mL
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.002 g in 1 mL
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.002 g in 1 mL
IVA ANNUA VAR. ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA VAR. ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA VAR. ANNUA POLLEN 0.002 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0672-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS332090
treatment set ts332090 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0673
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K) DERMATOPHAGOIDES PTERONYSSINUS 400 [AU] in 1 mL
DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q) DERMATOPHAGOIDES FARINAE 400 [AU] in 1 mL
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.002 g in 1 mL
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 400 [BAU] in 1 mL
CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR) CANIS LUPUS FAMILIARIS HAIR 0.002 g in 1 mL
IVA ANNUA VAR. ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA VAR. ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA VAR. ANNUA POLLEN 0.002 g in 1 mL
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.002 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.002 g in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.002 g in 1 mL
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.001 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.001 g in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 400 [BAU] in 1 mL
PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG) PHLEUM PRATENSE POLLEN 4000 [BAU] in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 4000 [AU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0673-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS332091
treatment set ts332091 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0674
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K) DERMATOPHAGOIDES PTERONYSSINUS 400 [AU] in 1 mL
DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q) DERMATOPHAGOIDES FARINAE 400 [AU] in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.002 g in 1 mL
CLADOSPORIUM HERBARUM (UNII: O64JF11198) (CLADOSPORIUM HERBARUM - UNII:O64JF11198) CLADOSPORIUM HERBARUM 0.002 g in 1 mL
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.002 g in 1 mL
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.002 g in 1 mL
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 0.002 [BAU] in 1 mL
CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR) CANIS LUPUS FAMILIARIS HAIR 0.0004 g in 1 mL
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 0.002 g in 1 mL
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.002 g in 1 mL
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.002 g in 1 mL
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.002 g in 1 mL
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.002 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.002 g in 1 mL
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.001 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.001 g in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 400 [BAU] in 1 mL
PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG) PHLEUM PRATENSE POLLEN 4000 [BAU] in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 4000 [AU] in 1 mL
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.002 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0674-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 12/21/2009
TREATMENT SET TS128811
treatment set ts128811 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0675
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS PENNSYLVANICA POLLEN (UNII: 2WZG2G15WX) (FRAXINUS PENNSYLVANICA POLLEN - UNII:2WZG2G15WX) FRAXINUS PENNSYLVANICA POLLEN 0.0025 g in 1 mL
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.0025 g in 1 mL
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 1428.6 [BAU] in 1 mL
FESTUCA PRATENSIS POLLEN (UNII: A0WFQ8P6N1) (FESTUCA PRATENSIS POLLEN - UNII:A0WFQ8P6N1) FESTUCA PRATENSIS POLLEN 1428.6 [BAU] in 1 mL
DACTYLIS GLOMERATA POLLEN (UNII: 83N78IDA7P) (DACTYLIS GLOMERATA POLLEN - UNII:83N78IDA7P) DACTYLIS GLOMERATA POLLEN 1428.6 [BAU] in 1 mL
LOLIUM PERENNE POLLEN (UNII: 4T81LB52R0) (LOLIUM PERENNE POLLEN - UNII:4T81LB52R0) LOLIUM PERENNE POLLEN 1428.6 [BAU] in 1 mL
AGROSTIS GIGANTEA POLLEN (UNII: HU8V6E7HOA) (AGROSTIS GIGANTEA POLLEN - UNII:HU8V6E7HOA) AGROSTIS GIGANTEA POLLEN 1428.6 [BAU] in 1 mL
ANTHOXANTHUM ODORATUM POLLEN (UNII: 2KIK19R45Y) (ANTHOXANTHUM ODORATUM POLLEN - UNII:2KIK19R45Y) ANTHOXANTHUM ODORATUM POLLEN 1428.6 [BAU] in 1 mL
ANTHOXANTHUM ODORATUM POLLEN (UNII: 2KIK19R45Y) (ANTHOXANTHUM ODORATUM POLLEN - UNII:2KIK19R45Y) ANTHOXANTHUM ODORATUM POLLEN 1428.6 [BAU] in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.005 g in 1 mL
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.005 g in 1 mL
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.005 g in 1 mL
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0675-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS129085
treatment set ts129085 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0676
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52) (MORUS RUBRA POLLEN - UNII:9LYI4RTZ52) MORUS RUBRA POLLEN 0.002 g in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.0004 g in 1 mL
ACER RUBRUM POLLEN (UNII: 700NK45C76) (ACER RUBRUM POLLEN - UNII:700NK45C76) ACER RUBRUM POLLEN 0.0004 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.0004 g in 1 mL
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.0004 g in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 80 [BAU] in 1 mL
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 32 [BAU] in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.00008 g in 1 mL
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.0004 g in 1 mL
URTICA DIOICA POLLEN (UNII: DNB59M1NVU) (URTICA DIOICA POLLEN - UNII:DNB59M1NVU) URTICA DIOICA POLLEN 0.002 g in 1 mL
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.0004 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 800 [AU] in 1 mL
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.0004 g in 1 mL
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.0004 g in 1 mL
DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q) DERMATOPHAGOIDES FARINAE 120 [AU] in 1 mL
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.0004 g in 1 mL
CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 0.002 g in 1 mL
MUCOR RACEMOSUS (UNII: 17RH99LQ7G) (MUCOR RACEMOSUS - UNII:17RH99LQ7G) MUCOR RACEMOSUS 0.002 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.002 g in 1 mL
DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K) DERMATOPHAGOIDES PTERONYSSINUS 120 [AU] in 1 mL
PLEOSPORA HERBARUM (UNII: 0N3Z1P4B2W) (PLEOSPORA HERBARUM - UNII:0N3Z1P4B2W) PLEOSPORA HERBARUM 0.002 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0676-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS329595
treatment set ts329595 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0677
Route of Administration SUBCUTANEOUS, INTRADERMAL
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 0.05 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 800 [AU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0677-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS129259
treatment set ts129259 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0678
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q) DERMATOPHAGOIDES FARINAE 400 [AU] in 1 mL
DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K) DERMATOPHAGOIDES PTERONYSSINUS 2000 [AU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0678-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS331657
treatment set ts331657 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0679
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.002 g in 1 mL
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 400 [BAU] in 1 mL
DACTYLIS GLOMERATA POLLEN (UNII: 83N78IDA7P) (DACTYLIS GLOMERATA POLLEN - UNII:83N78IDA7P) DACTYLIS GLOMERATA POLLEN 4000 [BAU] in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 800 [AU] in 1 mL
BETULA POPULIFOLIA POLLEN (UNII: 23H70FYJ5U) (BETULA POPULIFOLIA POLLEN - UNII:23H70FYJ5U) BETULA POPULIFOLIA POLLEN 0.002 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.002 g in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.002 g in 1 mL
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 4000 [BAU] in 1 mL
IVA ANNUA VAR. ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA VAR. ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA VAR. ANNUA POLLEN 0.002 g in 1 mL
ANTHOXANTHUM ODORATUM POLLEN (UNII: 2KIK19R45Y) (ANTHOXANTHUM ODORATUM POLLEN - UNII:2KIK19R45Y) ANTHOXANTHUM ODORATUM POLLEN 4000 [BAU] in 1 mL
LOLIUM PERENNE POLLEN (UNII: 4T81LB52R0) (LOLIUM PERENNE POLLEN - UNII:4T81LB52R0) LOLIUM PERENNE POLLEN 4000 [BAU] in 1 mL
PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG) PHLEUM PRATENSE POLLEN 4000 [BAU] in 1 mL
ALNUS RHOMBIFOLIA POLLEN (UNII: 7X8HL8GRTM) (ALNUS RHOMBIFOLIA POLLEN - UNII:7X8HL8GRTM) ALNUS RHOMBIFOLIA POLLEN 0.002 g in 1 mL
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.002 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.001 g in 1 mL
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
GLYCERIN (UNII: PDC6A3C0OX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0679-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS333519
treatment set ts333519 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0680
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ANTHOXANTHUM ODORATUM POLLEN (UNII: 2KIK19R45Y) (ANTHOXANTHUM ODORATUM POLLEN - UNII:2KIK19R45Y) ANTHOXANTHUM ODORATUM POLLEN 4000 [BAU] in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 2000 [BAU] in 1 mL
LOLIUM PERENNE POLLEN (UNII: 4T81LB52R0) (LOLIUM PERENNE POLLEN - UNII:4T81LB52R0) LOLIUM PERENNE POLLEN 4000 [BAU] in 1 mL
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 4000 [BAU] in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.01 g in 1 mL
DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K) DERMATOPHAGOIDES PTERONYSSINUS 2000 [AU] in 1 mL
DACTYLIS GLOMERATA POLLEN (UNII: 83N78IDA7P) (DACTYLIS GLOMERATA POLLEN - UNII:83N78IDA7P) DACTYLIS GLOMERATA POLLEN 4000 [BAU] in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 4000 [AU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
GLYCERIN (UNII: PDC6A3C0OX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0680-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS333743
treatment set ts333743 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0681
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 0.002 g in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 400 [BAU] in 1 mL
LOLIUM PERENNE POLLEN (UNII: 4T81LB52R0) (LOLIUM PERENNE POLLEN - UNII:4T81LB52R0) LOLIUM PERENNE POLLEN 4000 [BAU] in 1 mL
PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG) PHLEUM PRATENSE POLLEN 4000 [BAU] in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.002 g in 1 mL
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.002 g in 1 mL
ALNUS RHOMBIFOLIA POLLEN (UNII: 7X8HL8GRTM) (ALNUS RHOMBIFOLIA POLLEN - UNII:7X8HL8GRTM) ALNUS RHOMBIFOLIA POLLEN 0.002 g in 1 mL
BOS TAURUS HAIR (UNII: TOQ97Z8644) (BOS TAURUS HAIR - UNII:TOQ97Z8644) BOS TAURUS HAIR 0.002 g in 1 mL
DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K) DERMATOPHAGOIDES PTERONYSSINUS 400 [AU] in 1 mL
DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q) DERMATOPHAGOIDES FARINAE 400 [AU] in 1 mL
CLADOSPORIUM HERBARUM (UNII: O64JF11198) (CLADOSPORIUM HERBARUM - UNII:O64JF11198) CLADOSPORIUM HERBARUM 0.002 g in 1 mL
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.002 g in 1 mL
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 400 [BAU] in 1 mL
DACTYLIS GLOMERATA POLLEN (UNII: 83N78IDA7P) (DACTYLIS GLOMERATA POLLEN - UNII:83N78IDA7P) DACTYLIS GLOMERATA POLLEN 4000 [BAU] in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 4000 [AU] in 1 mL
BETULA POPULIFOLIA POLLEN (UNII: 23H70FYJ5U) (BETULA POPULIFOLIA POLLEN - UNII:23H70FYJ5U) BETULA POPULIFOLIA POLLEN 0.002 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.002 g in 1 mL
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 4000 [BAU] in 1 mL
EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 0.002 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0681-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS329802
treatment set ts329802 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0682
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K) DERMATOPHAGOIDES PTERONYSSINUS 400 [AU] in 1 mL
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.002 g in 1 mL
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.002 g in 1 mL
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 0.002 g in 1 mL
DACTYLIS GLOMERATA POLLEN (UNII: 83N78IDA7P) (DACTYLIS GLOMERATA POLLEN - UNII:83N78IDA7P) DACTYLIS GLOMERATA POLLEN 4000 [BAU] in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 4000 [AU] in 1 mL
BETULA POPULIFOLIA POLLEN (UNII: 23H70FYJ5U) (BETULA POPULIFOLIA POLLEN - UNII:23H70FYJ5U) BETULA POPULIFOLIA POLLEN 0.002 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.002 g in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.002 g in 1 mL
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 4000 [BAU] in 1 mL
ANTHOXANTHUM ODORATUM POLLEN (UNII: 2KIK19R45Y) (ANTHOXANTHUM ODORATUM POLLEN - UNII:2KIK19R45Y) ANTHOXANTHUM ODORATUM POLLEN 4000 [BAU] in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 400 [BAU] in 1 mL
LOLIUM PERENNE POLLEN (UNII: 4T81LB52R0) (LOLIUM PERENNE POLLEN - UNII:4T81LB52R0) LOLIUM PERENNE POLLEN 4000 [BAU] in 1 mL
PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG) PHLEUM PRATENSE POLLEN 4000 [BAU] in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.002 g in 1 mL
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.002 g in 1 mL
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.002 g in 1 mL
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.002 g in 1 mL
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.002 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.001 g in 1 mL
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.001 g in 1 mL
EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 0.002 g in 1 mL
COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 0.002 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0682-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS330316
treatment set ts330316 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0683
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q) DERMATOPHAGOIDES FARINAE 400 [AU] in 1 mL
DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K) DERMATOPHAGOIDES PTERONYSSINUS 400 [AU] in 1 mL
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 400 [BAU] in 1 mL
CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR) CANIS LUPUS FAMILIARIS HAIR 0.002 g in 1 mL
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 0.002 g in 1 mL
BOS TAURUS HAIR (UNII: TOQ97Z8644) (BOS TAURUS HAIR - UNII:TOQ97Z8644) BOS TAURUS HAIR 0.002 g in 1 mL
SUS SCROFA HAIR (UNII: 7Q7T9Z7QUW) (SUS SCROFA HAIR - UNII:7Q7T9Z7QUW) SUS SCROFA HAIR 0.002 g in 1 mL
CAPRA HIRCUS HAIR (UNII: 16M9MK8C4W) (CAPRA HIRCUS HAIR - UNII:16M9MK8C4W) CAPRA HIRCUS HAIR 0.002 g in 1 mL
MUCOR RACEMOSUS (UNII: 17RH99LQ7G) (MUCOR RACEMOSUS - UNII:17RH99LQ7G) MUCOR RACEMOSUS 0.002 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOL (UNII: 339NCG44TV)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0683-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS330317
treatment set ts330317 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0684
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.002 g in 1 mL
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.002 g in 1 mL
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.002 g in 1 mL
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.002 g in 1 mL
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.002 g in 1 mL
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.002 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.002 g in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.002 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.001 g in 1 mL
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.001 g in 1 mL
MORUS ALBA POLLEN (UNII: 3I9T68187H) (MORUS ALBA POLLEN - UNII:3I9T68187H) MORUS ALBA POLLEN 0.002 g in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 400 [BAU] in 1 mL
PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG) PHLEUM PRATENSE POLLEN 4000 [BAU] in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 4000 [AU] in 1 mL
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.002 g in 1 mL
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.002 g in 1 mL
IVA ANNUA VAR. ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA VAR. ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA VAR. ANNUA POLLEN 0.002 g in 1 mL
ANTHOXANTHUM ODORATUM POLLEN (UNII: 2KIK19R45Y) (ANTHOXANTHUM ODORATUM POLLEN - UNII:2KIK19R45Y) ANTHOXANTHUM ODORATUM POLLEN 4000 [BAU] in 1 mL
LOLIUM PERENNE POLLEN (UNII: 4T81LB52R0) (LOLIUM PERENNE POLLEN - UNII:4T81LB52R0) LOLIUM PERENNE POLLEN 4000 [BAU] in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.002 g in 1 mL
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.002 g in 1 mL
CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 0.002 g in 1 mL
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.002 g in 1 mL
ALNUS RHOMBIFOLIA POLLEN (UNII: 7X8HL8GRTM) (ALNUS RHOMBIFOLIA POLLEN - UNII:7X8HL8GRTM) ALNUS RHOMBIFOLIA POLLEN 0.002 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0684-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS333001
treatment set ts333001 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0685
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 400 [BAU] in 1 mL
CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR) CANIS LUPUS FAMILIARIS HAIR 0.002 g in 1 mL
PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG) PHLEUM PRATENSE POLLEN 4000 [BAU] in 1 mL
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.002 g in 1 mL
URTICA DIOICA POLLEN (UNII: DNB59M1NVU) (URTICA DIOICA POLLEN - UNII:DNB59M1NVU) URTICA DIOICA POLLEN 0.002 g in 1 mL
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.002 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 4000 [AU] in 1 mL
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.002 g in 1 mL
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.002 g in 1 mL
CELTIS OCCIDENTALIS POLLEN (UNII: 68R9X9Y96X) (CELTIS OCCIDENTALIS POLLEN - UNII:68R9X9Y96X) CELTIS OCCIDENTALIS POLLEN 0.002 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.002 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.002 g in 1 mL
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.002 g in 1 mL
JUGLANS CALIFORNICA POLLEN (UNII: 2147EPR64I) (JUGLANS CALIFORNICA POLLEN - UNII:2147EPR64I) JUGLANS CALIFORNICA POLLEN 0.002 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOL (UNII: 339NCG44TV)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0685-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS331802
treatment set ts331802 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0686
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.005 g in 1 mL
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.005 g in 1 mL
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.005 g in 1 mL
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.005 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.005 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 10000 [AU] in 1 mL
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0686-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS330170
treatment set ts330170 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0687
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON - UNII:2Q8MR21NHK) CYNODON DACTYLON POLLEN 400 [BAU] in 1 mL
PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG) PHLEUM PRATENSE POLLEN 800 [BAU] in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 4000 [AU] in 1 mL
IVA ANNUA VAR. ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA VAR. ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA VAR. ANNUA POLLEN 0.002 g in 1 mL
ANTHOXANTHUM ODORATUM POLLEN (UNII: 2KIK19R45Y) (ANTHOXANTHUM ODORATUM POLLEN - UNII:2KIK19R45Y) ANTHOXANTHUM ODORATUM POLLEN 800 [BAU] in 1 mL
LOLIUM PERENNE POLLEN (UNII: 4T81LB52R0) (LOLIUM PERENNE POLLEN - UNII:4T81LB52R0) LOLIUM PERENNE POLLEN 800 [BAU] in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.002 g in 1 mL
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.0002 g in 1 mL
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 400 [BAU] in 1 mL
CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR) CANIS LUPUS FAMILIARIS HAIR 0.002 g in 1 mL
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.002 g in 1 mL
BOS TAURUS HAIR (UNII: TOQ97Z8644) (BOS TAURUS HAIR - UNII:TOQ97Z8644) BOS TAURUS HAIR 0.002 g in 1 mL
SUS SCROFA HAIR (UNII: 7Q7T9Z7QUW) (SUS SCROFA HAIR - UNII:7Q7T9Z7QUW) SUS SCROFA HAIR 0.002 g in 1 mL
CAPRA HIRCUS HAIR (UNII: 16M9MK8C4W) (CAPRA HIRCUS HAIR - UNII:16M9MK8C4W) CAPRA HIRCUS HAIR 0.002 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0687-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS329123
treatment set ts329123 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0688
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 4000 [AU] in 1 mL
IVA ANNUA VAR. ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA VAR. ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA VAR. ANNUA POLLEN 0.002 g in 1 mL
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.002 g in 1 mL
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.002 g in 1 mL
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.002 g in 1 mL
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.002 g in 1 mL
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.002 g in 1 mL
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.002 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.002 g in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.002 g in 1 mL
ANTHOXANTHUM ODORATUM POLLEN (UNII: 2KIK19R45Y) (ANTHOXANTHUM ODORATUM POLLEN - UNII:2KIK19R45Y) ANTHOXANTHUM ODORATUM POLLEN 4000 [BAU] in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 400 [BAU] in 1 mL
LOLIUM PERENNE POLLEN (UNII: 4T81LB52R0) (LOLIUM PERENNE POLLEN - UNII:4T81LB52R0) LOLIUM PERENNE POLLEN 4000 [BAU] in 1 mL
PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG) PHLEUM PRATENSE POLLEN 4000 [BAU] in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.002 g in 1 mL
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.002 g in 1 mL
CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 0.002 g in 1 mL
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.002 g in 1 mL
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.002 g in 1 mL
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.002 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.001 g in 1 mL
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.001 g in 1 mL
MUCOR RACEMOSUS (UNII: 17RH99LQ7G) (MUCOR RACEMOSUS - UNII:17RH99LQ7G) MUCOR RACEMOSUS 0.002 g in 1 mL
MORUS ALBA POLLEN (UNII: 3I9T68187H) (MORUS ALBA POLLEN - UNII:3I9T68187H) MORUS ALBA POLLEN 0.002 g in 1 mL
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 0.002 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0688-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS331579
treatment set ts331579 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0689
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 400 [BAU] in 1 mL
CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR) CANIS LUPUS FAMILIARIS HAIR 0.002 g in 1 mL
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.01 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0689-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS329894
treatment set ts329894 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0690
Route of Administration INTRADERMAL, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.00017 g in 1 mL
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 1.33 [BAU] in 1 mL
DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K) DERMATOPHAGOIDES PTERONYSSINUS 833.33 [AU] in 1 mL
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.0083 g in 1 mL
MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52) (MORUS RUBRA POLLEN - UNII:9LYI4RTZ52) MORUS RUBRA POLLEN 0.0083 g in 1 mL
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.0083 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 16666 [AU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0690-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS333308
treatment set ts333308 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0691
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K) DERMATOPHAGOIDES PTERONYSSINUS 80 [AU] in 1 mL
DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q) DERMATOPHAGOIDES FARINAE 80 [AU] in 1 mL
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 80 [BAU] in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 80 [BAU] in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.002 g in 1 mL
ACER RUBRUM POLLEN (UNII: 700NK45C76) (ACER RUBRUM POLLEN - UNII:700NK45C76) ACER RUBRUM POLLEN 0.002 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.002 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.0004 g in 1 mL
MORUS ALBA POLLEN (UNII: 3I9T68187H) (MORUS ALBA POLLEN - UNII:3I9T68187H) MORUS ALBA POLLEN 0.002 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 800 [AU] in 1 mL
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.0004 g in 1 mL
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 160 [BAU] in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.0004 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.0004 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0691-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS332780
treatment set ts332780 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0692
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K) DERMATOPHAGOIDES PTERONYSSINUS 16 [AU] in 1 mL
DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q) DERMATOPHAGOIDES FARINAE 3.2 [AU] in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 3.2 [BAU] in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.0002 g in 1 mL
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 6.4 [BAU] in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.000016 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 160 [AU] in 1 mL
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.0002 g in 1 mL
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.0002 g in 1 mL
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.0002 g in 1 mL
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.0002 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0692-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS329905
treatment set ts329905 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0693
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 66.67 [BAU] in 1 mL
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.0017 g in 1 mL
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.0017 g in 1 mL
KOCHIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (KOCHIA SCOPARIA POLLEN - UNII:07A108ZKW5) KOCHIA SCOPARIA POLLEN 0.0017 g in 1 mL
IVA ANNUA VAR. ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA VAR. ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA VAR. ANNUA POLLEN 0.0017 g in 1 mL
AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 0.00056 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 0.00056 g in 1 mL
AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (AMBROSIA PSILOSTACHYA POLLEN - UNII:RX18M46K8L) AMBROSIA PSILOSTACHYA POLLEN 0.00056 g in 1 mL
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.0017 g in 1 mL
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.0017 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.00083 g in 1 mL
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.00083 g in 1 mL
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.0017 g in 1 mL
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.0017 g in 1 mL
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.0017 g in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.0017 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.0017 g in 1 mL
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.0003 g in 1 mL
BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 0.0003 g in 1 mL
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 666.67 [BAU] in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.0003 g in 1 mL
CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 0.0017 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0693-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS329906
treatment set ts329906 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0694
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUSARIUM OXYSPORUM (UNII: 5398RXP8KU) (FUSARIUM OXYSPORUM - UNII:5398RXP8KU) FUSARIUM OXYSPORUM 0.00083 g in 1 mL
CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 0.00083 g in 1 mL
COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 0.00083 g in 1 mL
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 0.00083 g in 1 mL
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.00017 g in 1 mL
USTILAGO CYNODONTIS (UNII: 0V3J4YEX2W) (USTILAGO CYNODONTIS - UNII:0V3J4YEX2W) USTILAGO CYNODONTIS 0.00042 g in 1 mL
SPORISORIUM CRUENTUM (UNII: GQM6LVU5V8) (SPORISORIUM CRUENTUM - UNII:GQM6LVU5V8) SPORISORIUM CRUENTUM 0.00042 g in 1 mL
PLEOSPORA HERBARUM (UNII: 0N3Z1P4B2W) (PLEOSPORA HERBARUM - UNII:0N3Z1P4B2W) PLEOSPORA HERBARUM 0.00083 g in 1 mL
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.00083 g in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.00083 g in 1 mL
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 0.00083 g in 1 mL
RHIZOPUS STOLONIFER (UNII: FEE198DK4Q) (RHIZOPUS STOLONIFER - UNII:FEE198DK4Q) RHIZOPUS STOLONIFER 0.00083 g in 1 mL
PHOMA DESTRUCTIVA (UNII: A17SE577FM) (PHOMA DESTRUCTIVA - UNII:A17SE577FM) PHOMA DESTRUCTIVA 0.00083 g in 1 mL
DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K) DERMATOPHAGOIDES PTERONYSSINUS 166.67 [AU] in 1 mL
CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR) CANIS LUPUS FAMILIARIS HAIR 0.00083 g in 1 mL
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.00083 g in 1 mL
DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q) DERMATOPHAGOIDES FARINAE 166.67 [AU] in 1 mL
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 166.67 [BAU] in 1 mL
USTILAGO NUDA HORDEI (UNII: 9Y53ZS6I82) (USTILAGO NUDA HORDEI - UNII:9Y53ZS6I82) USTILAGO NUDA HORDEI 0.00021 g in 1 mL
USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG) USTILAGO MAYDIS 0.00021 g in 1 mL
USTILAGO AVENAE (UNII: YIH315U1TU) (USTILAGO AVENAE - UNII:YIH315U1TU) USTILAGO AVENAE 0.00021 g in 1 mL
USTILAGO TRITICI (UNII: BV82OL2IZ8) (USTILAGO TRITICI - UNII:BV82OL2IZ8) USTILAGO TRITICI 0.00021 g in 1 mL
GALLUS GALLUS FEATHER (UNII: 1FCM16V0FV) (GALLUS GALLUS FEATHER - UNII:1FCM16V0FV) GALLUS GALLUS FEATHER 0.00028 g in 1 mL
ANAS PLATYRHYNCHOS FEATHER (UNII: 83B65P4796) (ANAS PLATYRHYNCHOS FEATHER - UNII:83B65P4796) ANAS PLATYRHYNCHOS FEATHER 0.00028 g in 1 mL
ANSER ANSER FEATHER (UNII: 15XI414745) (ANSER ANSER FEATHER - UNII:15XI414745) ANSER ANSER FEATHER 0.00028 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0694-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS332509
treatment set ts332509 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0695
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.002 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.002 g in 1 mL
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.002 g in 1 mL
BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 0.002 g in 1 mL
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 4000 [BAU] in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 400 [BAU] in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.002 g in 1 mL
DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K) DERMATOPHAGOIDES PTERONYSSINUS 16 [AU] in 1 mL
DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q) DERMATOPHAGOIDES FARINAE 16 [AU] in 1 mL
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 400 [BAU] in 1 mL
GALLUS GALLUS FEATHER (UNII: 1FCM16V0FV) (GALLUS GALLUS FEATHER - UNII:1FCM16V0FV) GALLUS GALLUS FEATHER 0.000668 g in 1 mL
ANAS PLATYRHYNCHOS FEATHER (UNII: 83B65P4796) (ANAS PLATYRHYNCHOS FEATHER - UNII:83B65P4796) ANAS PLATYRHYNCHOS FEATHER 0.000668 g in 1 mL
ANSER ANSER FEATHER (UNII: 15XI414745) (ANSER ANSER FEATHER - UNII:15XI414745) ANSER ANSER FEATHER 0.000668 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0695-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS330370
treatment set ts330370 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0696
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUSARIUM OXYSPORUM (UNII: 5398RXP8KU) (FUSARIUM OXYSPORUM - UNII:5398RXP8KU) FUSARIUM OXYSPORUM 0.0008 g in 1 mL
CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 0.0008 g in 1 mL
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 3333.33 [BAU] in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 333.33 [BAU] in 1 mL
COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 0.0008 g in 1 mL
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 0.0008 g in 1 mL
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.0008 g in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.0017 g in 1 mL
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 0.0008 g in 1 mL
RHIZOPUS STOLONIFER (UNII: FEE198DK4Q) (RHIZOPUS STOLONIFER - UNII:FEE198DK4Q) RHIZOPUS STOLONIFER 0.0008 g in 1 mL
PHOMA DESTRUCTIVA (UNII: A17SE577FM) (PHOMA DESTRUCTIVA - UNII:A17SE577FM) PHOMA DESTRUCTIVA 0.0008 g in 1 mL
DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K) DERMATOPHAGOIDES PTERONYSSINUS 333.33 [AU] in 1 mL
CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR) CANIS LUPUS FAMILIARIS HAIR 0.0008 g in 1 mL
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.00017 g in 1 mL
DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q) DERMATOPHAGOIDES FARINAE 333.33 [AU] in 1 mL
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 33.33 [BAU] in 1 mL
USTILAGO CYNODONTIS (UNII: 0V3J4YEX2W) (USTILAGO CYNODONTIS - UNII:0V3J4YEX2W) USTILAGO CYNODONTIS 0.00042 g in 1 mL
SPORISORIUM CRUENTUM (UNII: GQM6LVU5V8) (SPORISORIUM CRUENTUM - UNII:GQM6LVU5V8) SPORISORIUM CRUENTUM 0.00042 g in 1 mL
USTILAGO NUDA HORDEI (UNII: 9Y53ZS6I82) (USTILAGO NUDA HORDEI - UNII:9Y53ZS6I82) USTILAGO NUDA HORDEI 0.00021 g in 1 mL
USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG) USTILAGO MAYDIS 0.00021 g in 1 mL
USTILAGO AVENAE (UNII: YIH315U1TU) (USTILAGO AVENAE - UNII:YIH315U1TU) USTILAGO AVENAE 0.00021 g in 1 mL
USTILAGO TRITICI (UNII: BV82OL2IZ8) (USTILAGO TRITICI - UNII:BV82OL2IZ8) USTILAGO TRITICI 0.00021 g in 1 mL
PLEOSPORA HERBARUM (UNII: 0N3Z1P4B2W) (PLEOSPORA HERBARUM - UNII:0N3Z1P4B2W) PLEOSPORA HERBARUM 0.0008 g in 1 mL
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.0008 g in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0008 g in 1 mL
GALLUS GALLUS FEATHER (UNII: 1FCM16V0FV) (GALLUS GALLUS FEATHER - UNII:1FCM16V0FV) GALLUS GALLUS FEATHER 0.00028 g in 1 mL
ANAS PLATYRHYNCHOS FEATHER (UNII: 83B65P4796) (ANAS PLATYRHYNCHOS FEATHER - UNII:83B65P4796) ANAS PLATYRHYNCHOS FEATHER 0.00028 g in 1 mL
ANSER ANSER FEATHER (UNII: 15XI414745) (ANSER ANSER FEATHER - UNII:15XI414745) ANSER ANSER FEATHER 0.00028 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0696-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS330359
treatment set ts330359 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0697
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KOCHIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (KOCHIA SCOPARIA POLLEN - UNII:07A108ZKW5) KOCHIA SCOPARIA POLLEN 0.0017 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.00083 g in 1 mL
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.00083 g in 1 mL
CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 0.0017 g in 1 mL
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.0017 g in 1 mL
IVA ANNUA VAR. ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA VAR. ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA VAR. ANNUA POLLEN 0.0017 g in 1 mL
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.0017 g in 1 mL
AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 0.00011 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 0.00011 g in 1 mL
AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (AMBROSIA PSILOSTACHYA POLLEN - UNII:RX18M46K8L) AMBROSIA PSILOSTACHYA POLLEN 0.00011 g in 1 mL
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.0017 g in 1 mL
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.0017 g in 1 mL
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.0017 g in 1 mL
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.0017 g in 1 mL
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.0017 g in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.0017 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.0017 g in 1 mL
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.0017 g in 1 mL
BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 0.0017 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
GLYCERIN (UNII: PDC6A3C0OX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0697-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS330454
treatment set ts330454 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0698
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 0.00033 g in 1 mL
AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 0.0000044 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 0.0000044 g in 1 mL
AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (AMBROSIA PSILOSTACHYA POLLEN - UNII:RX18M46K8L) AMBROSIA PSILOSTACHYA POLLEN 0.0000044 g in 1 mL
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.0083 g in 1 mL
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.0017 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.00017 g in 1 mL
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.00017 g in 1 mL
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.000133 g in 1 mL
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.00033 g in 1 mL
BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 0.000133 g in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 66.67 [BAU] in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.000133 g in 1 mL
USTILAGO CYNODONTIS (UNII: 0V3J4YEX2W) (USTILAGO CYNODONTIS - UNII:0V3J4YEX2W) USTILAGO CYNODONTIS 0.0021 g in 1 mL
SPORISORIUM CRUENTUM (UNII: GQM6LVU5V8) (SPORISORIUM CRUENTUM - UNII:GQM6LVU5V8) SPORISORIUM CRUENTUM 0.0021 g in 1 mL
PLEOSPORA HERBARUM (UNII: 0N3Z1P4B2W) (PLEOSPORA HERBARUM - UNII:0N3Z1P4B2W) PLEOSPORA HERBARUM 0.00017 g in 1 mL
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.00083 g in 1 mL
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 0.0042 g in 1 mL
DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K) DERMATOPHAGOIDES PTERONYSSINUS 33.33 [AU] in 1 mL
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.00017 g in 1 mL
DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q) DERMATOPHAGOIDES FARINAE 33.33 [AU] in 1 mL
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 33.33 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0698-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS330583
treatment set ts330583 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0699
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.001 g in 1 mL
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.001 g in 1 mL
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 4000 [BAU] in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 400 [BAU] in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.00008 g in 1 mL
DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K) DERMATOPHAGOIDES PTERONYSSINUS 80 [AU] in 1 mL
DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q) DERMATOPHAGOIDES FARINAE 80 [AU] in 1 mL
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.002 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0699-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS331977
treatment set ts331977 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0700
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.0083 g in 1 mL
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.0017 g in 1 mL
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.0017 g in 1 mL
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.0083 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.0083 g in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.0017 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.00083 g in 1 mL
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.00083 g in 1 mL
PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG) PHLEUM PRATENSE POLLEN 16666.67 [BAU] in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 133.33 [AU] in 1 mL
IVA ANNUA VAR. ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA VAR. ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA VAR. ANNUA POLLEN 0.0017 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0700-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS331955
treatment set ts331955 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0701
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 26.67 [BAU] in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 2.67 [BAU] in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.0000133 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0701-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS332080
treatment set ts332080 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0702
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.00033 g in 1 mL
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 666.67 [BAU] in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 66.67 [BAU] in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.00033 g in 1 mL
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.00033 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.00033 g in 1 mL
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.00033 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
GLYCERIN (UNII: PDC6A3C0OX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0702-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS332594
treatment set ts332594 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0703
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.0000133 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.0000066 g in 1 mL
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.0000066 g in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.0000133 g in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 2.67 [BAU] in 1 mL
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 26.67 [BAU] in 1 mL
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.0000133 g in 1 mL
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.0000133 g in 1 mL
AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 0.0000066 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 0.0000066 g in 1 mL
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.0000133 g in 1 mL
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.0000133 g in 1 mL
IVA ANNUA VAR. ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA VAR. ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA VAR. ANNUA POLLEN 0.00033 g in 1 mL
KOCHIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (KOCHIA SCOPARIA POLLEN - UNII:07A108ZKW5) KOCHIA SCOPARIA POLLEN 0.0000133 g in 1 mL
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.0000133 g in 1 mL
CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 0.0000133 g in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.0000133 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.0000133 g in 1 mL
BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 0.0000133 g in 1 mL
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.0000133 g in 1 mL
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.0000133 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0703-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS331046
treatment set ts331046 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0704
Route of Administration SUBCUTANEOUS, INTRADERMAL
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 0.0042 g in 1 mL
CLADOSPORIUM HERBARUM (UNII: O64JF11198) (CLADOSPORIUM HERBARUM - UNII:O64JF11198) CLADOSPORIUM HERBARUM 0.0000333 g in 1 mL
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.00083 g in 1 mL
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.00017 g in 1 mL
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 166.67 [BAU] in 1 mL
CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR) CANIS LUPUS FAMILIARIS HAIR 0.00083 g in 1 mL
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.0017 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.000165 g in 1 mL
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.000165 g in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 333.33 [BAU] in 1 mL
PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG) PHLEUM PRATENSE POLLEN 666.67 [BAU] in 1 mL
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.0017 g in 1 mL
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.0017 g in 1 mL
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.0017 g in 1 mL
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.0017 g in 1 mL
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.00033 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.0017 g in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.00033 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 133.33 [BAU] in 1 mL
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.0017 g in 1 mL
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.0017 g in 1 mL
IVA ANNUA VAR. ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA VAR. ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA VAR. ANNUA POLLEN 0.0017 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0704-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS330376
treatment set ts330376 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0705
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.00033 g in 1 mL
AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 0.0000044 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 0.0000044 g in 1 mL
AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (AMBROSIA PSILOSTACHYA POLLEN - UNII:RX18M46K8L) AMBROSIA PSILOSTACHYA POLLEN 0.0000044 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.00033 g in 1 mL
CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 0.00017 g in 1 mL
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 133.33 [BAU] in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 66.67 [BAU] in 1 mL
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 0.00017 g in 1 mL
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.00017 g in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.00033 g in 1 mL
USTILAGO CYNODONTIS (UNII: 0V3J4YEX2W) (USTILAGO CYNODONTIS - UNII:0V3J4YEX2W) USTILAGO CYNODONTIS 0.000415 g in 1 mL
SPORISORIUM CRUENTUM (UNII: GQM6LVU5V8) (SPORISORIUM CRUENTUM - UNII:GQM6LVU5V8) SPORISORIUM CRUENTUM 0.000415 g in 1 mL
PLEOSPORA HERBARUM (UNII: 0N3Z1P4B2W) (PLEOSPORA HERBARUM - UNII:0N3Z1P4B2W) PLEOSPORA HERBARUM 0.00083 g in 1 mL
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.00083 g in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.00083 g in 1 mL
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 0.00083 g in 1 mL
USTILAGO NUDA HORDEI (UNII: 9Y53ZS6I82) (USTILAGO NUDA HORDEI - UNII:9Y53ZS6I82) USTILAGO NUDA HORDEI 0.00021 g in 1 mL
USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG) USTILAGO MAYDIS 0.00021 g in 1 mL
USTILAGO AVENAE (UNII: YIH315U1TU) (USTILAGO AVENAE - UNII:YIH315U1TU) USTILAGO AVENAE 0.00021 g in 1 mL
USTILAGO TRITICI (UNII: BV82OL2IZ8) (USTILAGO TRITICI - UNII:BV82OL2IZ8) USTILAGO TRITICI 0.00021 g in 1 mL
RHIZOPUS STOLONIFER (UNII: FEE198DK4Q) (RHIZOPUS STOLONIFER - UNII:FEE198DK4Q) RHIZOPUS STOLONIFER 0.00083 g in 1 mL
PHOMA DESTRUCTIVA (UNII: A17SE577FM) (PHOMA DESTRUCTIVA - UNII:A17SE577FM) PHOMA DESTRUCTIVA 0.00083 g in 1 mL
DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K) DERMATOPHAGOIDES PTERONYSSINUS 166.67 [AU] in 1 mL
CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR) CANIS LUPUS FAMILIARIS HAIR 0.00083 g in 1 mL
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.00083 g in 1 mL
DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q) DERMATOPHAGOIDES FARINAE 166.67 [AU] in 1 mL
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 33.33 [BAU] in 1 mL
GALLUS GALLUS FEATHER (UNII: 1FCM16V0FV) (GALLUS GALLUS FEATHER - UNII:1FCM16V0FV) GALLUS GALLUS FEATHER 0.00028 g in 1 mL
ANAS PLATYRHYNCHOS FEATHER (UNII: 83B65P4796) (ANAS PLATYRHYNCHOS FEATHER - UNII:83B65P4796) ANAS PLATYRHYNCHOS FEATHER 0.00028 g in 1 mL
ANSER ANSER FEATHER (UNII: 15XI414745) (ANSER ANSER FEATHER - UNII:15XI414745) ANSER ANSER FEATHER 0.00028 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0705-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS333246
treatment set ts333246 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0706
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q) DERMATOPHAGOIDES FARINAE 400 [AU] in 1 mL
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 80 [BAU] in 1 mL
CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR) CANIS LUPUS FAMILIARIS HAIR 0.002 g in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 80 [BAU] in 1 mL
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 160 [BAU] in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.0004 g in 1 mL
MUCOR RACEMOSUS (UNII: 17RH99LQ7G) (MUCOR RACEMOSUS - UNII:17RH99LQ7G) MUCOR RACEMOSUS 0.002 g in 1 mL
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.00008 g in 1 mL
PLEOSPORA HERBARUM (UNII: 0N3Z1P4B2W) (PLEOSPORA HERBARUM - UNII:0N3Z1P4B2W) PLEOSPORA HERBARUM 0.004 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.002 g in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.004 g in 1 mL
ACER RUBRUM POLLEN (UNII: 700NK45C76) (ACER RUBRUM POLLEN - UNII:700NK45C76) ACER RUBRUM POLLEN 0.004 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.002 g in 1 mL
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.002 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 800 [AU] in 1 mL
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.002 g in 1 mL
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.002 g in 1 mL
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.004 g in 1 mL
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.004 g in 1 mL
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 0.002 g in 1 mL
COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 0.002 g in 1 mL
FUSARIUM OXYSPORUM (UNII: 5398RXP8KU) (FUSARIUM OXYSPORUM - UNII:5398RXP8KU) FUSARIUM OXYSPORUM 0.002 g in 1 mL
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.002 g in 1 mL
EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 0.002 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0706-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS331810
treatment set ts331810 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0707
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.0083 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.00085 g in 1 mL
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.00085 g in 1 mL
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.0017 g in 1 mL
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.0083 g in 1 mL
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.0083 g in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.0017 g in 1 mL
MORUS ALBA POLLEN (UNII: 3I9T68187H) (MORUS ALBA POLLEN - UNII:3I9T68187H) MORUS ALBA POLLEN 0.0083 g in 1 mL
URTICA DIOICA POLLEN (UNII: DNB59M1NVU) (URTICA DIOICA POLLEN - UNII:DNB59M1NVU) URTICA DIOICA POLLEN 0.0083 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0707-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS331632
treatment set ts331632 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0708
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K) DERMATOPHAGOIDES PTERONYSSINUS 833.33 [AU] in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.00083 g in 1 mL
CLADOSPORIUM HERBARUM (UNII: O64JF11198) (CLADOSPORIUM HERBARUM - UNII:O64JF11198) CLADOSPORIUM HERBARUM 0.00017 g in 1 mL
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.00083 g in 1 mL
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.00017 g in 1 mL
CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR) CANIS LUPUS FAMILIARIS HAIR 0.00083 g in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 333.33 [BAU] in 1 mL
PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG) PHLEUM PRATENSE POLLEN 3333.33 [BAU] in 1 mL
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.000067 g in 1 mL
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.0083 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 666.67 [AU] in 1 mL
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.0083 g in 1 mL
IVA ANNUA VAR. ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA VAR. ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA VAR. ANNUA POLLEN 0.0017 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0708-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS332626
treatment set ts332626 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0709
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K) DERMATOPHAGOIDES PTERONYSSINUS 166.67 [AU] in 1 mL
DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q) DERMATOPHAGOIDES FARINAE 166.67 [AU] in 1 mL
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 33.33 [BAU] in 1 mL
CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR) CANIS LUPUS FAMILIARIS HAIR 0.00083 g in 1 mL
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 0.0042 g in 1 mL
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.00033 g in 1 mL
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.0017 g in 1 mL
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.00033 g in 1 mL
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.00033 g in 1 mL
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.0017 g in 1 mL
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.0017 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.00033 g in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.00033 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.00085 g in 1 mL
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.00085 g in 1 mL
MORUS ALBA POLLEN (UNII: 3I9T68187H) (MORUS ALBA POLLEN - UNII:3I9T68187H) MORUS ALBA POLLEN 0.0083 g in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 66.67 [BAU] in 1 mL
PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG) PHLEUM PRATENSE POLLEN 666.67 [BAU] in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 133.33 [AU] in 1 mL
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.0017 g in 1 mL
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.00033 g in 1 mL
IVA ANNUA VAR. ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA VAR. ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA VAR. ANNUA POLLEN 0.00033 g in 1 mL
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.00033 g in 1 mL
URTICA DIOICA POLLEN (UNII: DNB59M1NVU) (URTICA DIOICA POLLEN - UNII:DNB59M1NVU) URTICA DIOICA POLLEN 0.0017 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0709-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS333315
treatment set ts333315 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0710
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 0.00011 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 0.00011 g in 1 mL
AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (AMBROSIA PSILOSTACHYA POLLEN - UNII:RX18M46K8L) AMBROSIA PSILOSTACHYA POLLEN 0.00011 g in 1 mL
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 8333.33 [BAU] in 1 mL
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 0.0042 g in 1 mL
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.0042 g in 1 mL
DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K) DERMATOPHAGOIDES PTERONYSSINUS 833.33 g in 1 mL
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.0042 g in 1 mL
DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q) DERMATOPHAGOIDES FARINAE 833.33 [AU] in 1 mL
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 833.33 [BAU] in 1 mL
CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 0.00033 g in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.00033 g in 1 mL
USTILAGO CYNODONTIS (UNII: 0V3J4YEX2W) (USTILAGO CYNODONTIS - UNII:0V3J4YEX2W) USTILAGO CYNODONTIS 0.0021 g in 1 mL
SPORISORIUM CRUENTUM (UNII: GQM6LVU5V8) (SPORISORIUM CRUENTUM - UNII:GQM6LVU5V8) SPORISORIUM CRUENTUM 0.0021 g in 1 mL
GALLUS GALLUS FEATHER (UNII: 1FCM16V0FV) (GALLUS GALLUS FEATHER - UNII:1FCM16V0FV) GALLUS GALLUS FEATHER 0.0014 g in 1 mL
ANAS PLATYRHYNCHOS FEATHER (UNII: 83B65P4796) (ANAS PLATYRHYNCHOS FEATHER - UNII:83B65P4796) ANAS PLATYRHYNCHOS FEATHER 0.0014 g in 1 mL
ANSER ANSER FEATHER (UNII: 15XI414745) (ANSER ANSER FEATHER - UNII:15XI414745) ANSER ANSER FEATHER 0.0014 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0710-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS330453
treatment set ts330453 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0711
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 0.002 g in 1 mL
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.002 g in 1 mL
KOCHIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (KOCHIA SCOPARIA POLLEN - UNII:07A108ZKW5) KOCHIA SCOPARIA POLLEN 0.002 g in 1 mL
IVA ANNUA VAR. ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA VAR. ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA VAR. ANNUA POLLEN 0.002 g in 1 mL
AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 0.00067 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 0.00067 g in 1 mL
AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (AMBROSIA PSILOSTACHYA POLLEN - UNII:RX18M46K8L) AMBROSIA PSILOSTACHYA POLLEN 0.00067 g in 1 mL
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.002 g in 1 mL
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.002 g in 1 mL
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.002 g in 1 mL
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.002 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.001 g in 1 mL
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.001 g in 1 mL
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.002 g in 1 mL
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.002 g in 1 mL
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.002 g in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.002 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.002 g in 1 mL
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.002 g in 1 mL
BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 0.002 g in 1 mL
FUSARIUM OXYSPORUM (UNII: 5398RXP8KU) (FUSARIUM OXYSPORUM - UNII:5398RXP8KU) FUSARIUM OXYSPORUM 0.002 g in 1 mL
CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 0.002 g in 1 mL
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 4000 [BAU] in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 400 [BAU] in 1 mL
COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 0.002 g in 1 mL
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 0.002 g in 1 mL
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.002 g in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.002 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0711-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS329388
treatment set ts329388 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0712
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IVA ANNUA VAR. ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA VAR. ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA VAR. ANNUA POLLEN 0.0083 g in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 333.33 [BAU] in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.0017 g in 1 mL
DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K) DERMATOPHAGOIDES PTERONYSSINUS 166.67 [AU] in 1 mL
DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q) DERMATOPHAGOIDES FARINAE 166.67 [AU] in 1 mL
FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96) FELIS CATUS HAIR 1.33 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0712-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS331327
treatment set ts331327 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0713
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 160 [BAU] in 1 mL
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.002 g in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 400 [BAU] in 1 mL
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.002 g in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.00008 g in 1 mL
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.002 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0713-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS334128
treatment set ts334128 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0772
Route of Administration SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 160 [BAU] in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.00008 g in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 0.000027 g in 1 mL
AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 0.000027 g in 1 mL
AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (AMBROSIA PSILOSTACHYA POLLEN - UNII:RX18M46K8L) AMBROSIA PSILOSTACHYA POLLEN 0.000027 g in 1 mL
CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR) CANIS LUPUS FAMILIARIS HAIR 0.002 g in 1 mL
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 0.002 g in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 16 [BAU] in 1 mL
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.002 g in 1 mL
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.00008 g in 1 mL
PHOMA DESTRUCTIVA (UNII: A17SE577FM) (PHOMA DESTRUCTIVA - UNII:A17SE577FM) PHOMA DESTRUCTIVA 0.002 g in 1 mL
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.002 g in 1 mL
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.00008 g in 1 mL
CARYA ALBA POLLEN (UNII: G2A764T54B) (CARYA ALBA POLLEN - UNII:G2A764T54B) CARYA ALBA POLLEN 0.00004 g in 1 mL
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.00004 g in 1 mL
BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 0.00008 g in 1 mL
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.00008 g in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.00008 g in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.002 g in 1 mL
KOCHIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (KOCHIA SCOPARIA POLLEN - UNII:07A108ZKW5) KOCHIA SCOPARIA POLLEN 0.002 g in 1 mL
CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 0.002 g in 1 mL
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.002 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PHENOL (UNII: 339NCG44TV)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49288-0772-3 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
Labeler - Antigen Laboratories, Inc. (030705628)
Registrant - Antigen Laboratories, Inc. (030705628)
Establishment
Name Address ID/FEI Business Operations
Antigen Laboratories, Inc. 030705628 manufacture

Revised: 12/2009 Antigen Laboratories, Inc.



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