Acacia Pollen

Allermed Laboratories, Inc.

ALLERGENIC EXTRACT INSTRUCTIONS FOR USE AND DOSAGE SCHEDULE

FULL PRESCRIBING INFORMATION: CONTENTS*

• WARNINGS
• ACACIA POLLEN DESCRIPTION
• CLINICAL PHARMACOLOGY
• ACACIA POLLEN INDICATIONS AND USAGE
• ACACIA POLLEN CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• ACACIA POLLEN ADVERSE REACTIONS
• OVERDOSAGE
• ACACIA POLLEN DOSAGE AND ADMINISTRATION
• SUPPLIED
• REFERENCES

FULL PRESCRIBING INFORMATION

ACACIA POLLEN DESCRIPTION

Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.

CLINICAL PHARMACOLOGY

Positive skin tests with allergenic extract are the result of histamine release from mast cells sensitized with allergen specific IgE. The exact mechanisms by which immunotherapy relieves symptoms of allergy are still under investigation. Elevations in allergen-specific IgG antibodies and an increase in the activity of T suppressor lymphocytes appear to be some of the immunologic changes that occur from hyposensitization.^1,2,3

ACACIA POLLEN INDICATIONS AND USAGE

Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease.^4,5,6
Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms.^7-12
Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.

ACACIA POLLEN CONTRAINDICATIONS

Allergenic extract should not be administered to a non-allergic person. However, there are no absolute contraindications to the use of allergenic extract for treatment in appropriate individuals. Relative contraindications include: EXTREME SENSITIVITY TO AN ALLERGEN - Determined from the allergic history, or from previous anaphylaxis following skin testing or subcutaneous injection; AUTOIMMUNE DISEASE - Individuals with autoimmune disease may be at risk, due to the possibility of routine immunizations exacerbating symptoms of the underlying disease; PREGNANCY - In limited controlled studies of women receiving allergenic extract during conception and throughout all trimesters of pregnancy, no evidence was found that extract is harmful to the fetus or mother. However, because of the known pharmacologic action of histamine on uterine muscle, any treatment that might result in the release of significant amounts of this mediator should be avoided if possible¹³. See Precaution #4; MYOCARDIAL INFARCTION - Patients who have experienced a recent myocardial infarction may not be able to tolerate immunotherapy. As in all of the above circumstances, the benefit to risk ration must be carefully evaluated; BLEEDING DIATHESIS - Patients with a bleeding tendency should not be tested or treated with allergenic extract, unless the physician responsible believes that such procedures are safe to perform.
Allergenic extract should be temporarily withheld from patients if any of the following conditions exist: (1) severe symptoms of hay fever and/or asthma; (2) infection or flu accompanied by fever; and (3) exposure to excessive amounts of clinically relevant allergens prior to skin testing or immunotherapy.

WARNINGS

The only approved method for determining hypersensitivity to Allermed Laboratories Allergenic Extracts is by diagnostic skin testing (See DOSAGE AND ADMINISTRATION — DIAGNOSIS).
Physicians who administer allergenic extract should have emergency medication and equipment available to treat anaphylaxis¹⁴. See Precautions, Adverse Reactions and Overdosage below.
To reduce the risk of anaphylaxis, the following measures must be observed:

• Concentrated extract must be diluted before use for intradermal skin testing and for beginning immunotherapy. It should never be injected intravenously during testing or treatment procedures.
• Patients who are highly sensitive, determined from clinical findings and test results, may require that treatment start with a very weak concentration of extract, such as 1:10,000,000 v/v.
• The dosage of fresh (new) extract given to a patient receiving maintenance injections must be reduced to one-fourth the amount given from the previous (old) lot (See Immunotherapy, last paragraph).
• Patients who are transferred to standardized extract after previous treatment with unstandardized extract must be skin tested with serial dilutions, starting with a 1:100,000 v/v dilution of the standardized extract, to determine a safe, non-reacting starting dose.
• Patients who are transferred to this extract after treatment with alum precipitated or other modified extract must re-start injections with the beginning recommended dose of this extract.

PRECAUTIONS

• Extract should be stored at 2°C to 8°C since higher temperatures may adversely affect the stability of the product. Do not freeze.
• After the needle is inserted subcutaneously, the plunger should be withdrawn slightly to check for the presence of blood in the syringe. If blood is observed, a new injection should be prepared and given at another site, observing the same precautions.
• Treatment with beta-blocking drugs may make patients refractory to the usual dose of epinephrine, in the event epinephrine is required to control an adverse allergic reaction.
• PREGNANCY CATEGORY C. Allergenic extract. Animal reproduction studies have not been conducted with allergenic extract. It is also not known whether allergenic extract can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Allergenic extract should be given to a pregnant woman only if clearly needed.
• PATIENT INSTRUCTIONS: Patients should be instructed to remain in the physician's office for at least 20 minutes after skin testing and after each treatment injection, and immediately notify the physician if symptoms of a generalized reaction or shock occur.
• CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: Long term studies have not been conducted with allergenic extracts to determine their potential for carcinogenesis, mutagenesis, and impairment of fertility.
• LACTATION: Data are not available on the secretion of allergenic extract in human milk and it is not known what affect this might have on the nursing infant.
• PEDIATRIC USE: The dose of allergenic extract recommended for children is the same as that used for adults, except in the injection of large doses of extract for treatment. In this case, the amount of extract given to a child may be modified so that the discomfort of the injection is minimized.

ACACIA POLLEN ADVERSE REACTIONS

Local Reactions: The occurrence of a hive 5 to 15 minutes after the subcutaneous injection of extract does not require a reduction in dosage. However, a local reaction with edema larger than 2 cm in diameter or swelling and redness that persist for several hours or longer indicates that too much extract has been given. Treatment should be altered as follows:

• Additional injections should not be given until all evidence of the reaction has disappeared.
• The next injection administered should be 50% of the last non-reacting dose or less, depending upon the size and severity of the local reaction.
• Subsequent injections should be continued at the reduced dosage unless the physician responsible for treatment believes that it is safe to increase the dose, and that possible clinical improvement would result form the administration of a larger dose of extract.
  
  

Systemic Reactions:Systemic (generalized) reactions may range from a mild exacerbation of the patient's allergic symptoms to hives, anaphylactic shock, or even death from anaphylaxis. The reaction usually occurs 5 to 20 minutes after injection. As a rule, the more quickly a reaction develops, the more serious it is likely to become. Symptoms may include sneezing, coughing, itching, shortness of breath, abdominal cramps, vomiting, diarrhea, tachycardia, hypotension and respiratory failure in severe cases. The reaction is usually stopped by the subcutaneous injection of Epinephrine HCL 1:1,000 (See Overdosage below). The oral administration of antihistamines and the placement of a tourniquet proximal to the injection site are helpful adjuncts. In the event that additional measures are required, it may be necessary to treat the patient for BRONCHOSPASM with intravenous aminophylline, intravenous fluids and corticosteroids; for HYPOTENSION with vasopressors, volume repletion, isoproterenol and corticosteroids; for LARYNGEAL OBSTRUCTION with oxygen and tracheostomy and for CARDIAC ARREST with cardiopulmonary resuscitation and other appropriate measures.
Immunotherapy after anaphylaxis should be continued if the cause of the reaction can be identified and appropriate precautions taken to insure that a subsequent reaction does not occur.

OVERDOSAGE

A strong local reaction to the injection of extract may be treated with oral antihistamines and the local application of a cold compress. The dosage must be reduced and additional extract must not be given until all evidence of the reaction has disappeared.
A systemic reaction following the injection of extract must be treated immediately. Reported procedures include (Ref. #4, vol. 2, p. 888):

• 0.01 mL/kg up to 0.2 mL of aqueous epinephrine HCL 1:1000 subcutaneously at the injection site of antigen.
• 0.01 mL/kg up to 0.3 mL of aqueous epinephrine HCL 1:1000 subcutaneously at another site.
• Diphenhydramine intravenously or intramuscularly, 1.25 mg/kg up to 50 mg.
• Tourniquet above the injection site of antigen.

Specific reactions:

• Brochospasm: intravenous aminophylline 4 mg/kg up to 500 mg given over 10 to 15 minutes, aqueous hydrocortisone 5 mg/kg up to 200 mg, oxygen.
• Laryngeal edema: oxygen, intubation, tracheostomy.
• Hypotension: vasopressors, fluids, corticosteroids.
• Cardiac arrest: resuscitation, sodium bicarbonate, defibrillation, antiarrhythmia medications.

ACACIA POLLEN DOSAGE AND ADMINISTRATION

Diagnosis: Concentrated extract may be used for scratch or prick testing providing the patient is not extremely sensitive. In this case, the extract should be diluted 10 fold before a scratch or prick test is performed. Extract for intradermal testing must be used as follows:

a. Patients with a negative scratch or prick test: Patients who do not react who do not react to a valid scratch or prick test should be tested intradermally with 0.05 mL of a 1:1000 v/v dilution of the concentrate. If the test is negative, a second test should be performed with 0.05 mL of a 1:100 v/v dilution or concentrate.
b. Patients with positive scratch or prick tests: It is not advisable to perform an intradermal skin test if the patient has a positive scratch or prick test.
c. Patients tested only by the intradermal method: Patients suspected of being highly allergic should be tested with 0.05 mL of a 1:100,000 v/v dilution of the concentrate. A negative test should be followed by repeat tests using 10 fold stronger concentrations until the maximum dose of 0.05 mL of a 1:100 v/v dilution is reached.

Interpretation of Results
Scratch and Prick Test
A negative test shows only a slight red area at the site of scarification or prick penetration. Positive tests are scored as follows:

1+ Erythema with 5 mm wheal
2+ Erythema with a 5-10 mm wheal
3+ Erythema with a 10-15 mm wheal
4+ Erythema with a wheal 15 mm (or larger) with pseudopodia

Intradermal Test
A negative test shows no change in the appearance and size of the 5 mm wheal created by the I.D. injection of 0.05 mL of extract. Positive tests are scored as follows:

1+ Erythema 10-20 mm with a 5-10 mm wheal
2+ Erythema 20-30 mm with a 5-10 mm wheal
3+ Erythema 30-40 mm with a 10-15 mm wheal
4+ Erythema greater than 40 mm with a 15 mm wheal (or larger) with pseudopodia

Immunotherapy

Allergenic extract should be administered subcutaneously in the outer aspect of the upper arm using a sterile tuberculin syringe and needle. The skin should be cleaned with 70% alcohol and aseptic technique should be observed in removing the extract from the vial. Care must be taken to avoid injecting the extract into a blood vessel because of the risk of anaphylaxis.
Concentrated extract must be diluted before administration to new patients. A 1:100,000 v/v dilution of concentrate is usually satisfactory to start treatment. However, as a precaution against overdose, a skin test with the intended starting dose should be done to help evaluate the patient's sensitivity to the product. If the skin response is larger than 5 mm edema/15 mm erythema, the extract is too strong and must be diluted before it is given subcutaneously. The doses shown in the Dosage Schedule (Table 1) below are recommended unless the patient's skin test response and allergic history indicates that more dilute extract should be used.
Little is known about the required accumulated dosage of allergen that is needed to relieve symptoms. However, studies have shown that high dose immunotherapy is efficacious in the treatment of allergic rhinitis and asthma. For this reason, treatment with extract from Vial #5 is recommended, providing the patient can tolerate the extract without experiencing local or systemic reactions. Treatment with Vial #6 may be used for patients who have not had adverse reactions to extract in Vial #5 and who require more concentrated extract to control or relieve symptoms.
Patients who have received allergenic extract for maintenance therapy SHOULD NOT be given the same dose from a fresh vial of extract. IT IS ADVISABLE TO REDUCE THE DOSAGE OF FRESH EXTRACT TO ONE-FOURTH THE AMOUNT GIVEN FROM A PREVIOUS LOT OF EXTRACT MADE AT THE SAME CONCENTRATION AND BY THE SAME FORMULA.

Table 1 - Suggested Dosage Schedule

No.	Vial #1 1:100,000 w/v frequency twice weekly mL	Vial #2 1:10,000 w/v frequency twice weekly mL	Vial #3 1:1,000 w/v frequency once weekly mL	Vial #4 1:100 w/v frequency once weekly mL	Vial #5 1:10 w/v frequency every two-four weeks mL	Vial #6 Concentrate frequency every two-four weeks mL
1	0.025	0.025	0.025	0.025	0.025	0.025
2	0.05	0.05	0.05	0.05	0.05	0.05
3	0.10	0.10	0.10	0.10	0.10	0.10
4	0.15	0.15	0.15	0.15	0.15	0.15
5	0.20	0.20	0.20	0.20	0.20	0.20
6	0.25	0.25	0.25	0.25	0.25	0.25
7	0.30	0.30	0.30	0.30	0.30	0.30

SUPPLIED

Allergenic extract is supplied in dropper vials for scratch or prick testing and in 10, 30, and 50 mL vials for bulk use.

WARRANTY

Allermed Laboratories, Inc. certifies that allergenic extract prepared within the Laboratories meets the safety and sterility standards of the F.D.A. Because the Laboratories have no control over the conditions under which extract is sued, or the purposes intended, neither a good nor a bad effect following its administration is warranted.
The users of this product should be aware of the potential dangers involved in the injection of allergenic extract and accept the risk of any consequences resulting from such injections.
No representatives of the Laboratories may change this warranty whether written, oral or implied. The buyer or user must assume full responsibility for the product after it leaves the premises of the Laboratories.

REFERENCES

• Levy, D.A., L.M., Lichtenstein, E.O. Goldstein and K. Ishizaka. Immunologic and cellular changes accompanying the therapy of pollen allergy. J. Clinical Investigations. 50:360, 1971.
• Evans, R., H. Pence, H. Kaplan and R. Rocklin. The effect of immunotherapy on humoral and cellular response in ragweed hayfever. J. Clinical Investigations. 57:1378, 1976.
• Ishizaka, K. Cellular events in the IgE antibody response. Adv. In Immunology. 23:50, 1976.
• Middleton, Elliott, Jr., C.E. Reed and E.F. Ellis (Eds.) Allergy, Principles and Practice Vols. 1&2, C.V. Mosby 1978.
• Sheldon, J.M., R.G. Lovell and K.P. Matthews. A Manual of Clinical Allergy. W.B. Saunders, 1967.
• Nelson, H.S. Diagnostic procedures in allergy. I. Allergy skin testing. Ann. Allergy. 51:411, 1983.
• Norma, P.S., W.L. Winkenwerder and L.M. Lichtenstein. Immunotherapy of hay fever with ragweed antigen E: comparisons with whole pollen extract and placebos. J. Allergy. 42:93, 1968.
• Milner, F.H. and E.C. Tees. Specific sensitivity to individual grass pollens in some hay fever patients. Clinical Allergy. 2:83, 1972.
• Frankland, A.W. and R. Augustine. Grass pollen antigens effective in treatment. Clinical Science. 23:95, 1962.
• Pence, H.L., D.Q. Mitchell, R.L. Greely, B.R. Updegraff and H.A. Selfridge. Immunotherapy for mountain cedar pollinosis: a double-blind controlled study. J. Allergy ad Clinical Immunology. 58:39, 1976.
• Taylor, W.W., J.L. Ohman, Jr. and F.C. Lowell. Immunotherapy in cat-induced asthma. Double-blind trial with evaluation of bronchial responses to cat allergen and histamine. J. Allergy and Clinical Immunology. 61:283. 1978.
• Lichtenstein, L.M., M.D. Valentine and A.K. Sobotka. Insect allergies. The state of the art. J. Allergy and Clinical Immunology. 61:268, 1978.
• Metzger, W.J., E. Turner and R. Patterson. The safety of immunotherapy during pregnancy. J. Allergy and Clinical Immunology. 61:268. 1978.
• Ouellette, J.J. Emergency management of allergic reactions. Modern Medicine 99, 1975.

Acacia Pollen Acacia spp. INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-301 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACACIA POLLEN ACACIA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-301-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-301-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-301-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-301-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Alder, White Pollen Alnus rhombifolia INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-312 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALNUS RHOMBIFOLIA POLLEN ALNUS RHOMBIFOLIA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-312-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-312-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-312-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-312-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Alfalfa Pollen Medicago sativa INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-300 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MEDICAGO SATIVA POLLEN MEDICAGO SATIVA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-300-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-300-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-300-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-300-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Alkali Blite Pollen Suaeda spp. INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-414 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SUAEDA MOQUINII POLLEN SUAEDA MOQUINII POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-414-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-414-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-414-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-414-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Alternaria Alternaria alternata INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-101 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA ALTERNARIA ALTERNATA 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-101-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-101-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-101-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-101-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

American Elm Pollen Ulmus americana INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-417 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ULMUS AMERICANA POLLEN ULMUS AMERICANA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-417-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-417-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-417-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-417-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Arizona Ash Pollen Fraxinus velutina INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-359 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS VELUTINA POLLEN FRAXINUS VELUTINA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-359-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-359-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-359-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-359-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Arroyo Willow Pollen Salix lasiolepsis INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-408 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALIX LASIOLEPIS POLLEN SALIX LASIOLEPIS POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-408-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-408-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-408-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-408-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Aspen Pollen Populus tremuloides INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-398 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS TREMULOIDES POLLEN POPULUS TREMULOIDES POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-398-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-398-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-398-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-398-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Aspergillus fumigatus Aspergillus fumigatus INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-130 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-130-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-130-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-130-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-130-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Australian Pine Pollen Casuarina equisetifoli INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-335 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CASUARINA EQUISETIFOLIA POLLEN CASUARINA EQUISETIFOLIA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-335-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-335-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-335-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-335-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Bahia Grass Pollen Paspalum notatum INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-384 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASPALUM NOTATUM POLLEN PASPALUM NOTATUM POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-384-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-384-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-384-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-384-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Bassia Pollen Bassia hyssopifolia INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-323 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BASSIA HYSSOPIFOLIA POLLEN BASSIA HYSSOPIFOLIA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-323-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-323-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-323-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-323-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Beech Pollen Fagus grandifolia INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-349 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAGUS GRANDIFOLIA POLLEN FAGUS GRANDIFOLIA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-349-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-349-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-349-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-349-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Black Cottonwood Pollen Populus trichocarpa INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-399 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS BALSAMIFERA SSP. TRICHOCARPA POLLEN POPULUS BALSAMIFERA SSP. TRICHOCARPA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-399-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-399-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-399-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-399-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Black Oak Pollen Quercus velutina INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-451 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS VELUTINA POLLEN QUERCUS VELUTINA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-451-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-451-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-451-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-451-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Black Walnut Pollen Juglans nigra INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-366 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUGLANS NIGRA POLLEN JUGLANS NIGRA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-366-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-366-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-366-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-366-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Black Willow Pollen Salix nigra INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-409 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALIX NIGRA POLLEN SALIX NIGRA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-409-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-409-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-409-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-409-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Botrytis Botrytis cinerea INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-104 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOTRYTIS CINEREA BOTRYTIS CINEREA 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-104-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-104-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-104-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-104-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Bottlebrush Pollen Callistemon citrinus INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-330 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Callistemon citrinus pollen CALLISTEMON CITRINUS POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-330-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-330-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-330-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-330-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Box Elder Maple Pollen Acer negundo INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-303 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER NEGUNDO POLLEN ACER NEGUNDO POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-303-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-303-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-303-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-303-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Burning Bush Pollen Kochia scoparia INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-374 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KOCHIA SCOPARIA POLLEN KOCHIA SCOPARIA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-374-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-374-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-374-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-374-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Burrobrush Pollen Hymenoclea salsola INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-362 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYMENOCLEA SALSOLA POLLEN HYMENOCLEA SALSOLA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-362-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-362-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-362-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-362-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Burweed Marshelder Pollen Iva xanthifolia INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-365 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IVA XANTHIFOLIA POLLEN IVA XANTHIFOLIA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-365-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-365-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-365-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-365-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Calif. Black Walnut Pollen Juglans californica INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-446 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUGLANS CALIFORNICA POLLEN JUGLANS CALIFORNICA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-446-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-446-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-446-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-446-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

California Juniper Pollen Juniperus californica INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-368 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS CALIFORNICA POLLEN JUNIPERUS CALIFORNICA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-368-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-368-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-368-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-368-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

California Scrub Oak Pollen Quercus dumosa INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-403 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS DUMOSA POLLEN QUERCUS DUMOSA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-403-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-403-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-403-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-403-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Canary Grass Pollen Phalaris arundinaceae INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-385 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHALARIS ARUNDINACEA POLLEN PHALARIS ARUNDINACEA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-385-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-385-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-385-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-385-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Candida Candida albicans INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-105 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDIDA ALBICANS candida albicans 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-105-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-105-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-105-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-105-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Canyon Ragweed Pollen Ambrosia ambrosioides INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-352 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA AMBROSIOIDES POLLEN AMBROSIA AMBROSIOIDES POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-352-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-352-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-352-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-352-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Careless Weed Pollen Amaranthus palmerii INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-313 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS PALMERI POLLEN AMARANTHUS PALMERI POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-313-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-313-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-313-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-313-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Cattle Epithelia Cattle Epithelia INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-003 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOS TAURUS SKIN BOS TAURUS SKIN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-003-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-003-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-003-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-003-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Cephalosporium Cephalosporium roseum INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-106 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CEPHALOSPORIUM ROSEUM CEPHALOSPORIUM ROSEUM 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-106-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-106-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-106-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-106-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Chaetomium Chaetomium globosum INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-107 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHAETOMIUM GLOBOSUM CHAETOMIUM GLOBOSUM 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-107-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-107-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-107-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-107-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Cheat Grass Pollen Bromus secalinus INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-329 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMUS SECALINUS POLLEN BROMUS SECALINUS POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-329-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-329-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-329-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-329-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Cherry Birch Pollen Betula lenta INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-442 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA LENTA POLLEN BETULA LENTA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-442-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-442-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-442-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-442-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Chinese Elm Pollen Ulmus pumila INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-419 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ULMUS PUMILA POLLEN ULMUS PUMILA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-419-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-419-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-419-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-419-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Cladosporium Cladosporium herbarum INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-108 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM HERBARUM CLADOSPORIUM HERBARUM 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-108-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-108-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-108-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-108-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Coast Live Oak Pollen Quercus agrifolia INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-401 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS AGRIFOLIA POLLEN QUERCUS AGRIFOLIA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-401-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-401-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-401-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-401-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Coast Maple Pollen Acer macrophyllum INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-302 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER MACROPHYLLUM POLLEN ACER MACROPHYLLUM POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-302-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-302-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-302-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-302-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Coast Sage Pollen Artemisia californica INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-437 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA CALIFORNICA POLLEN ARTEMISIA CALIFORNICA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-437-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-437-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-437-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-437-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Cocklebur Pollen Xanthium commune INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-420 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength XANTHIUM STRUMARIUM POLLEN XANTHIUM STRUMARIUM POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-420-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-420-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-420-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-420-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Cockroach, American Periplaneta americana INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-047 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERIPLANETA AMERICANA PERIPLANETA AMERICANA 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-047-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-047-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-047-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-047-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Cockroach, German Blattella germanica INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-048 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLATELLA GERMANICA BLATELLA GERMANICA 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-048-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-048-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-048-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-048-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Common Sage Pollen Artemisia tridentata INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-320 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA TRIDENTATA POLLEN ARTEMISIA TRIDENTATA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-320-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-320-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-320-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-320-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Corn Pollen Pollen Zea mays INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-422 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZEA MAYS POLLEN ZEA MAYS POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-422-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-422-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-422-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-422-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Cotton Linters Cotton Linters INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-004 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COTTON FIBER COTTON FIBER 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-004-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-004-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-004-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-004-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Cottonseed Cottonseed INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-005 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COTTON SEED 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-005-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-005-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-005-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-005-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Cultivated Oat Pollen Avena sativa INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-322 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVENA SATIVA POLLEN AVENA SATIVA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-322-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-322-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-322-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-322-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Curvularia Curvularia lunata INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-109 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCHLIOBOLUS LUNATUS COCHLIOBOLUS LUNATUS 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-109-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-109-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-109-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-109-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Cypress, Arizona Pollen Cupressus arizonica INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-341 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CUPRESSUS ARIZONICA POLLEN CUPRESSUS ARIZONICA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-341-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-341-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-341-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-341-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Dandelion Pollen Taraxacum officinale INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-416 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TARAXACUM OFFICINALE POLLEN TARAXACUM OFFICINALE POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-416-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-416-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-416-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-416-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Date Palm Pollen Phoenix dactylifera INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-387 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHOENIX DACTYLIFERA POLLEN PHOENIX DACTYLIFERA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-387-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-387-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-387-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-387-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Desert Ragweed Pollen Ambrosia dumosa INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-355 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA DUMOSA POLLEN AMBROSIA DUMOSA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-355-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-355-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-355-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-355-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Dock, Yellow Pollen Rumex crispus INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-406 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RUMEX CRISPUS POLLEN RUMEX CRISPUS POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-406-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-406-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-406-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-406-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Dog Hair Dog Hair INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-006 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANIS LUPUS FAMILIARIS HAIR CANIS LUPUS FAMILIARIS HAIR 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-006-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-006-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-006-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-006-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Eastern Cottonwood Pollen Populus deltoides INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-395 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS DELTOIDES POLLEN POPULUS DELTOIDES POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-395-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-395-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-395-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-395-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Eastern Sycamore Pollen Platanus occidentalis INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-391 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLATANUS OCCIDENTALIS POLLEN PLATANUS OCCIDENTALIS POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-391-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-391-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-391-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-391-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Eastern White Pine Pollen Pinus strobus INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-388 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PINUS STROBUS POLLEN PINUS STROBUS POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-388-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-388-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-388-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-388-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

English Plantain Pollen Plantago lanceolata INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-389 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLANTAGO LANCEOLATA POLLEN PLANTAGO LANCEOLATA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-389-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-389-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-389-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-389-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

English Walnut Pollen Juglans regia INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-367 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUGLANS REGIA POLLEN JUGLANS REGIA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-367-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-367-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-367-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-367-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Epicoccum Epicoccum nigrum INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-110 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPICOCCUM NIGRUM EPICOCCUM NIGRUM 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-110-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-110-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-110-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-110-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Eucalyptus Pollen Eucalyptus globulus INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-347 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTUS GLOBULUS POLLEN EUCALYPTUS GLOBULUS POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-347-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-347-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-347-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-347-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

European Olive Pollen Olea europea INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-383 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLEA EUROPAEA POLLEN OLEA EUROPAEA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-383-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-383-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-383-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-383-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

False Ragweed Pollen Ambrosia acanthicarpa INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-351 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA ACANTHICARPA POLLEN AMBROSIA ACANTHICARPA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-351-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-351-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-351-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-351-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Flaxseed Flaxseed INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-010 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLAX SEED FLAX SEED 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-010-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-010-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-010-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-010-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Fremont Cottonwood Pollen Populus fremontii INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-396 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS FREMONTII POLLEN POPULUS FREMONTII POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-396-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-396-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-396-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-396-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Fusarium Fusarium solani INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-111 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HAEMATONECTRIA HAEMATOCOCCA HAEMATONECTRIA HAEMATOCOCCA 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-111-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-111-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-111-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-111-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Gambels Oak Pollen Quercus gambelii INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-404 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS GAMBELII POLLEN QUERCUS GAMBELII POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-404-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-404-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-404-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-404-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Giant Ragweed Pollen Ambrosia trifida INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-317 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA TRIFIDA POLLEN AMBROSIA TRIFIDA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-317-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-317-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-317-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-317-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Glycerol-Saline Control Glycerol-Saline Diluent INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-818 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN 53 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-818-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-818-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-818-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-818-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Goat Epithelia Goat Epithelia INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-011 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPRA HIRCUS SKIN CAPRA HIRCUS SKIN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-011-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-011-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-011-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-011-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Grama grass Pollen Bouteloua spp. INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-326 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOUTELOUA GRACILIS POLLEN BOUTELOUA GRACILIS POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-326-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-326-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-326-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-326-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Gray (White) Birch Pollen Betula populifolia INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-325 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA POPULIFOLIA POLLEN BETULA POPULIFOLIA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-325-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-325-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-325-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-325-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Greasewood Pollen Sarcobatus vermiculatus INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-411 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SARCOBATUS VERMICULATUS POLLEN SARCOBATUS VERMICULATUS POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-411-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-411-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-411-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-411-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Green Ash Pollen Fraxinus pennsylvanica INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-358 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS PENNSYLVANICA POLLEN FRAXINUS PENNSYLVANICA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-358-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-358-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-358-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-358-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Guinea Pig Epithelia Guinea Pig Epithelia INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-012 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAVIA PORCELLUS SKIN CAVIA PORCELLUS SKIN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-012-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-012-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-012-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-012-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Hackberry Pollen Celtis occidentalis INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-336 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CELTIS OCCIDENTALIS POLLEN CELTIS OCCIDENTALIS POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-336-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-336-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-336-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-336-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Hamster Epithelia Hamster Epithelia INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-013 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MESOCRICETUS AURATUS SKIN MESOCRICETUS AURATUS SKIN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-013-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-013-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-013-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-013-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Hard Maple Pollen Acer saccharum INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-452 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER SACCHARUM POLLEN ACER SACCHARUM POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-452-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-452-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-452-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-452-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Hazelnut Pollen Corylus americana INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-340 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CORYLUS AMERICANA POLLEN CORYLUS AMERICANA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-340-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-340-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-340-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-340-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Helminthosporium sativum Helminthosporium sativum INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-112 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCHLIOBOLUS SATIVUS COCHLIOBOLUS SATIVUS 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-112-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-112-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-112-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-112-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Hog Epithelia Hog Epithelia INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-014 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SUS SCROFA SKIN SUS SCROFA SKIN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-014-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-014-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-014-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-014-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Horse Epithelia Horse Epithelia INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-015 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EQUUS CABALLUS SKIN EQUUS CABALLUS SKIN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-015-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-015-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-015-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-015-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

House Dust House Dust INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-008 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST HOUSE DUST 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-008-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-008-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-008-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-008-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Iodine Bush Pollen Allenrolfea occidentalis INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-311 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLENROLFEA OCCIDENTALIS POLLEN ALLENROLFEA OCCIDENTALIS POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-311-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-311-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-311-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-311-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Johnson Grass Pollen Sorghum halepense INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-413 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SORGHUM HALEPENSE POLLEN SORGHUM HALEPENSE POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-413-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-413-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-413-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-413-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Jute Jute INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-016 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CORCORUS CAPSULARIS FIBER CORCORUS CAPSULARIS FIBER 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-016-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-016-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-016-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-016-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Kapok Kapok INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-017 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CEIBA PENTANDRA FIBER CEIBA PENTANDRA FIBER 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-017-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-017-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-017-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-017-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Karaya Gum Karaya Gum INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-018 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Karaya Gum KARAYA GUM 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-018-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-018-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-018-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-018-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Koelers Grass Pollen Koeleria cristata INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-375 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KOELERIA MACRANTHA POLLEN KOELERIA MACRANTHA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-375-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-375-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-375-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-375-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Lambs Quarters Pollen Chenopodium album INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-339 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHENOPODIUM ALBUM POLLEN CHENOPODIUM ALBUM POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-339-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-339-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-339-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-339-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Lens Scale Pollen Atriplex lentiformis INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-440 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATRIPLEX LENTIFORMIS POLLEN ATRIPLEX LENTIFORMIS POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-440-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-440-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-440-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-440-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Linden Pollen Tilia cordata INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-460 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TILIA CORDATA POLLEN TILIA CORDATA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-460-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-460-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-460-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-460-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Lombard Poplar Pollen Populus nigra INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-397 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS NIGRA POLLEN POPULUS NIGRA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-397-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-397-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-397-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-397-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Melaleuca Pollen Melaleuca leucadendron INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-380 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MELALEUCA QUINQUENERVIA POLLEN MELALEUCA QUINQUENERVIA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-380-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-380-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-380-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-380-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Mesquite Pollen Prosopis juliflora INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-400 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROSOPIS JULIFLORA POLLEN PROSOPIS JULIFLORA POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-400-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-400-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-400-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-400-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Monilia Monilia sitophila INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-113 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHRYSONILIA SITOPHILA CHRYSONILIA SITOPHILA 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-113-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-113-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-113-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-113-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Mountain Cedar Pollen Juniperus sabinoides INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-371 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS ASHEI POLLEN JUNIPERUS ASHEI POLLEN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-371-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-371-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-371-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-371-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12

Mouse Epithelia Mouse Epithelia INJECTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:49643-019 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUS MUSCULUS SKIN MUS MUSCULUS SKIN 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN PHENOL water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49643-019-05 5 in 1 VIAL, MULTI-DOSE 2 NDC:49643-019-10 10 in 1 VIAL, MULTI-DOSE 3 NDC:49643-019-30 30 in 1 VIAL, MULTI-DOSE 4 NDC:49643-019-50 50 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102212 1974-03-12