Animal Allergens, AP Horse Hair and Dander

Jubilant HollisterStier LLC
Jubilant HollisterStier LLC

ALLERGENIC EXTRACTS IN BULK VIALS

FULL PRESCRIBING INFORMATION: CONTENTS*

• WARNINGS
• ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER DESCRIPTION
• CLINICAL PHARMACOLOGY
• ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER INDICATIONS AND USAGE
• ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • 1. General
  • 2. Information for Patients
  • 3. Drug Interactions
  • 4. Carcinogenesis, Mutagenesis, Impairment of Fertility
  • 5. Pregnancy
  • 6. Nursing Mothers
  • 7. Pediatric Use
  • 8. Geriatric Use
• ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER ADVERSE REACTIONS
• OVERDOSE SECTION
• ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER DOSAGE AND ADMINISTRATION 1. General
  • 2. Pediatric Use
  • 3. Geriatric Use
• HOW SUPPLIED
• STORAGE AND HANDLING
• LIMITED WARRANTY
• REFERENCES

FULL PRESCRIBING INFORMATION

ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER DESCRIPTION

The allergenic extract in this vial is referred to as a "bulk" extract or stock concentrate since it is designed primarily for the physician equipped to prepare dilutions and mixtures as required. The extract is sterile and intended for subcutaneous injection for immunotherapy and scratch, prick or puncture for diagnosis. Unless specified otherwise, the concentration of extract supplied will in most cases be expressed in weight to volume (e.g., 1:10 or 1:20 w/v) and will be the strongest available. Where mixtures of pollens and non-pollens have been ordered, the mixed extract will be treated as a pollen mixture. To insure maximum potency for the entire dating period, all bulk concentrates will contain 50% volume to volume (v/v) glycerin unless otherwise requested. Dilutions will also be prepared with 50% (v/v) glycerin unless another diluent is specified.
Source materials utilized in allergenic extract products include pollens, molds, animal epidermals, insects, foods and environmental materials.
Pollens are collected using techniques such as waterset or vacuuming, cleaned and purified to greater than 99% single specie pollen (less than 1% foreign particle presence).
Molds are typically grown on synthetic nutrient medias and are derived from the surface growth (mycelia).
Animal source materials are collected from animals deemed to be healthy at the time of collection by a veterinarian or individual trained and certified by a veterinarian. Epidermals include feathers, hair and dander, or the whole epidermal (pelt) as described on product labeling.
Regular process epidermals are extractions of the source material without additional processing, except that certain materials are defatted. AP™ (acetone precipitated) epidermal source materials are derived from the precipitate formed when acetone is added to an aqueous extract. The resulting precipitate is dried, and becomes the source material for the AP™ product.
Insects are collected in whole body form. Extractions take place as whole body or ground insects.
Information on Foods and other Environmental source materials can be obtained by contacting our Customer Service Department.
The following is a brief summary of the six methods of describing allergenic product concentration.

1. Weight to volume (w/v). Weight to volume (w/v) describes the weight of allergenic source material added to a given volume of extracting fluid. A 1:10 w/v extract, e.g., indicates that the solution contains the extractable material from one gram of raw material added to each 10 mL Glycero-Coca's or 10 mL Coca's extracting fluid. The amount and composition of extracted materials will vary with the type of antigen, the extracting fluid, duration of extraction, pH, temperature, and other variables. Pollens are typically extracted at a 1:20 w/v ratio in Glycero-Coca's while Coca's extracts are 1:10 w/v. Epidermal, environmental, regular molds and insect products are typically extracted at 1:10 w/v. AP™ (acetone precipitated) epidermal products are prepared at a 1:50 w/v concentration (i.e., 1 gram of dried precipitate in 50 mL of reconstitution fluid). AP™ Dog Hair-Dander is prepared at 1:100 w/v concentration. (i.e., 1 gram of dried precipitate in 100 mL of reconstitution fluid.)

2. Protein Nitrogen Units per mL (PNU/mL). One protein nitrogen unit represents 0.00001 mg phosphotungstic acid precipitable protein nitrogen dissolved in one mL of antigen extract. The PNU content of extracts of the same antigen may vary according to the method of measuring the PNU. Thus, the PNU content of extracts from different manufacturers is not comparable unless the PNU method is known to be the same and is reproducible from lot to lot. The amount of protein nitrogen extracted from the source material is influenced by such factors as the type of antigen, the extracting fluid, duration of extraction, pH, temperature and other variables. Allergenic materials make up a variable proportion of the total protein of an extract. Most allergenic extracts are assayed for PNU. Specific PNU information is available upon request.

3. Amb a 1. Of the many allergens from Short Ragweed which have been purified and characterized [Amb a 1 3 (also known as Antigen E), Amb a 2 3 (also known as Antigen K), Ra3 4, Ra4 (BPA-R) 5, Ra5 6, Ra6, Ra7, Ra87, and cytochrome C 8], Amb a 1 is considered the most important and has been selected as the basis for standardization. Extracts of Short Ragweed containing Amb a 1 are diffused in agar against standard anti-serum to Amb a 1, and compared to the diffusion of standard Amb a 1 solutions. The amount of Amb a 1 is expressed as units of Amb a 1 per mL of extract. A Short Ragweed pollen extracted at 1:20 (w/v) usually assays within a range of 50,000 to 70,000 PNU/mL and 100 to 300 units of Amb a 1 per mL.
The Amb a 1 concentration of any Short Ragweed extract which is diluted with a diluent or other allergenic extracts is determined by calculation. The resulting Amb a 1 value does not reflect the total potency of the product if Short Ragweed extract is mixed with another allergenic extract.

4. Allergy Units per mL (AU/mL). The potency of extracts labeled in Allergy Units (AU)/mL is determined by in vitro comparison to a reference standard established by the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA).

5. Bioequivalent Allergy Units per mL (BAU/mL). Other standardized allergenic extracts are labeled in Bioequivalent Allergy Units/mL (BAU/mL) based on their comparison (by in vitro assay or major allergen content) to CBER, FDA Reference Preparations. The FDA reference extracts have been assigned Bioequivalent Allergy Units based on the CBER ID₅₀EAL method.9 Briefly, highly sensitive patients are skin tested to the reference preparation using an intradermal technique employing 3-fold extract dilutions. Depending on the dilution which elicits a summation of erythema diameter of 50, Bioequivalent Allergy Units are assigned as follows:

BAU/mL	D50 Range
100,000	13.9 - 15.9
10,000	10.9 - 12.9
1,000	8.8 - 10.8
100	6.7 - 8.7

References labeled 10,000 BAU/mL can be diluted one to a half million fold, and references labeled 100,000 BAU/mL can be diluted one to 5 million fold and produce a sum of erythema diameter of 50 mm when Intradermal testing highly reactive subjects.

6. Concentrate. Concentrate label terminology applies to allergenic extract mixtures, where the individual allergens being combined vary in strength or the designation of strength.

e.g. Concentrate
50% Short Ragweed 1:20 w/v
25% Std. Cat Pelt 10,000 BAU/mL
25% Mite D. farinae 10,000 AU/mL

Should the physician choose to calculate the actual strength of each component in the "Concentrate" mixture, the following formulation may be used:

Actual Allergen Strength in Concentrate	=	Allergen Manufacturing Strength	X	% Allergen in Formulation (by volume or parts)

Ingredients: Active ingredients are the allergen(s) noted on the vial label. Preservative is 50% (v/v) glycerin, or 0.4% phenol, as indicated on the vial label. Additional ingredients are 0.5% sodium chloride, and 0.275% sodium bicarbonate.

CLINICAL PHARMACOLOGY

11, 12, 13, 1410, 15, 16, 17, 18, 19

ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER INDICATIONS AND USAGE

20,21,22,23

Allergenic extracts are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific environmental allergens. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing.
The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed antigen.
Avoidance of allergens is to be advocated if possible, but cannot always be attained, e.g., allergy to dog dander in kennel owners and employees, dog breeders, research workers, veterinarians, etc.
Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur with the highly reactive allergen.

ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER CONTRAINDICATIONS

PRECAUTIONSWARNINGS
1

2

WARNINGS

WARNINGS PRECAUTIONS






DOSAGE AND ADMINISTRATION
DOSAGE AND ADMINISTRATION

DOSAGE AND ADMINISTRATIONADVERSE REACTIONS


ADVERSE REACTIONSPRECAUTIONSADVERSE REACTIONS WARNINGS

PRECAUTIONS

1. General

1, 24, 25, 26, 27
DOSAGE and ADMINISTRATION






ADVERSE REACTIONS WARNINGS

ADVERSE REACTIONS

2. Information for Patients

WARNINGS

3. Drug Interactions

Patients with cardiovascular diseases and/or pulmonary diseases such as symptomatic unstable, steroid-dependent asthma, and/or those who are receiving cardiovascular drugs such as beta blockers, may be at higher risk for severe adverse reactions. These patients may also be more refractory to the normal allergy treatment regimen. Patients should be treated only if the benefit of treatment outweighs the risks.1
Patients on beta blockers may be more reactive to allergens given for testing or treatment and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.2 (See WARNINGS). Certain medications may lessen the skin test wheal and erythema responses elicited by allergens and histamine for varying time periods. Conventional antihistamines should be discontinued at least 5 days before skin testing. Long acting antihistamines should be discontinued for at least 3 weeks prior to skin testing. 28 Topical steroids should be discontinued at the skin test site for at least 2-3 weeks before skin testing.28, 29
Tricyclic antidepressants such as Doxepin should be withheld for at least 7 days before skin testing. 30 Topical local anesthetics may suppress the flare responses and should be avoided in skin test sites.31

4. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been conducted with allergenic extracts to determine their potential for carcinogenicity, mutagenicity or impairment of fertility.

5. Pregnancy

WARNINGS PRECAUTIONS 33

6. Nursing Mothers

There are no current studies on the secretion of allergenic extract components in human milk or their effect on the nursing infant. Because many drugs are excreted in human milk, caution should be exercised when allergenic extracts are administered to a nursing woman.

7. Pediatric Use

34, 35

8. Geriatric Use

The reactions from immunotherapy can be expected to be the same in elderly patients as in younger ones. Elderly patients may be more likely to be on medication that could block the effect of epinephrine which could be used to treat serious reactions, or they could be more sensitive to the cardiovascular side effect of epinephrine because of pre-existing cardiovascular disease. 36

ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER ADVERSE REACTIONS

Physicians administering allergenic extract testing or treatment materials should be experienced in the treatment of severe systemic reactions. See WARNINGS box at the beginning of this package insert.
1. Local Reactions
Some erythema, swelling or pruritus at the site of injection are common, the extent varying with the patient. Such reactions should not be considered significant unless they persist for at least 24 hours. Local reactions (erythema or swelling) which exceed 4-5 cm in diameter are not only uncomfortable, but also indicate the possibility of a systemic reaction if dosage is increased. In such cases the dosage should be reduced to the last level not causing the reaction and maintained at this level for two or three treatments before cautiously increasing again. Large persistent local reactions may be treated by local cold, wet dressings and/or the use of oral antihistamines. They should be considered a warning of possible severe systemic reactions and an indication of the need for temporarily reduced dosages. A mild burning immediately after the injection is to be expected. This usually subsides in 10 to 20 seconds.

2. Systemic Reactions
With careful attention to dosage and administration, systemic reactions occur infrequently, but it cannot be overemphasized that in sensitive individuals, any injection could result in anaphylactic shock. Therefore, it is imperative that physicians administering allergenic extracts understand and be prepared for the treatment of severe reactions.
Most severe systemic reactions will begin within a 30 minute time period, but systemic reactions may occur at any time after skin tests or immunotherapy. Symptoms may range from mild to life-threatening (due to anaphylaxis)as described below.
Other possible systemic reactions which may occur in varying degrees of severity are laryngeal edema, fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis, and urticaria. Adverse reaction frequency data for allergenic extract administration for testing and treatment show that risk is low. 1, 37
If a systemic or anaphylactic reaction does occur, apply a tourniquet above the site of injection and inject 1:1,000 epinephrine-hydrochloride intramuscularly or subcutaneously into the opposite arm. Loosen the tourniquet at least every 10 minutes. Do not obstruct arterial blood flow with the tourniquet.
EPINEPHRINE DOSAGE:
ADULT: 0.3 to 0.5 mL should be injected. Repeat in 5 to 10 minutes if necessary.
PEDIATRIC: The usual initial dose is 0.01 mg (mL) per kg body weight or 0.3 mg (mL) per square meter of body surface area. Suggested dosage for infants to 2 years of age is 0.05 mL to 0.1 mL; for children 2 to 6 years, 0.15 mL; and children 6 to 12 years, 0.2 mL. Single pediatric doses should not exceed 0.3 mg (mL). Doses may be repeated as frequently as every 20 minutes, depending on the severity of the condition and the response of the patient. After administration of epinephrine, profound shock or vasomotor collapse should be treated with intravenous fluids, and possibly vasoactive drugs. Airway patency should be insured. Oxygen should be given by mask. Intravenous antihistamine, inhaled bronchodilators, theophylline and/or adrenal corticosteroids may be used if necessary after adequate epinephrine and circulatory support has been given. Emergency resuscitation measures and personnel trained in their use must be available immediately in the event of a serious systemic or anaphylactic reaction not responsive to the above measures [Ref. J. Allergy and Clinical Immunology, 77(2):p. 271-273, 1986].
Rarely are all of the above measures necessary; the tourniquet and epinephrine usually produce prompt responses. However, the physician should be prepared in advance for all contingencies. Promptness in beginning emergency treatment measures is of utmost importance.
Severe systemic reactions mandate a decrease of at least 50% in the next dose, followed by cautious increases. Repeated systemic reactions, even of a mild nature, are sufficient reason for the cessation of further attempts to increase the reaction-causing dose.

3. Adverse Event Reporting
Report all adverse events to Jubilant HollisterStier LLC, Customer Technical Services Department at 1 (800) 992-1120. A voluntary adverse event reporting system for health professionals is available through the FDA MEDWATCH program. Preprinted forms (FDA Form 3500) are available from the FDA by calling 1 (800) FDA-1088. Completed forms should be mailed to MEDWATCH, 5600 Fisher Lane, Rockville, MD 20852-9787 or Fax to: 1 (800) FDA-0178.

OVERDOSE SECTION

See ADVERSE REACTIONS.

DOSAGE AND ADMINISTRATION 1. General

DESCRIPTION



WARNINGS

2. Pediatric Use

The dose for the pediatric population is the same as for adults.

3. Geriatric Use

The dose for elderly patients is the same as for adult patients under 65.36

HOW SUPPLIED

In 10 mL, 30 mL and 50 mL vials at the w/v, Concentrate, v/v dilution of Concentrate, AU/mL (Standardized Mite Extracts: D. farinae, D. pteronyssinus 10,000 and 30,000 AU/mL; Mite Mixtures: 5,000 AU/mL each species, or 15,000 AU/mL each species), BAU/mL (Standardized Cat Hair and Cat Pelt extracts: 10,000 BAU/mL; Standardized Grass extracts: 10,000 and 100,000 BAU/mL); Amb a 1 units/mL; or PNU/mL ordered by the physician. Please see the current Allergy Product Catalog.

STORAGE AND HANDLING

The expiration date is listed on the container label. To ensure the maximum potency, the extract and its dilutions should be stored at 2° - 8°C, and kept in this temperature range at all times, even during use. Dilutions are less stable than concentrates. If loss of potency is suspected, dilutions should be checked by skin testing with equal v/v dilutions of a freshly prepared dilution on individuals known to be allergic to the specific allergen.

LIMITED WARRANTY

A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use. No warranty, express or implied, including any warranty of merchantability or fitness, is made. Representatives of the Company are not authorized to vary the terms or the contents of any printed labeling, including the package insert, for this product except by printed notice from the Company's headquarters. The prescriber and user of this product must accept the terms hereof.

REFERENCES

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In Vivo

Animal Allergens, AP Horse Hair and Dander AP Horse Hair and Dander INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-4855 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EQUUS CABALLUS HAIR EQUUS CABALLUS HAIR 0.01 g EQUUS CABALLUS DANDER Equus caballus dander 0.01 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4855-2 10 in 1 VIAL 2 NDC:65044-4855-3 30 in 1 VIAL 3 NDC:65044-4855-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1978-01-30

Animal Allergens, AP Cattle Hair and Dander Cattle Hair and Dander INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-4811 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOS TAURUS HAIR BOS TAURUS HAIR 0.01 g BOS TAURUS DANDER Bos taurus dander 0.01 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4811-2 10 in 1 VIAL 2 NDC:65044-4811-3 30 in 1 VIAL 3 NDC:65044-4811-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1978-01-30

Animal Allergens, AP Dog Hair and Dander Canis spp Animal Allergens, Dog Dander Canis spp INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-4824 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANIS LUPUS FAMILIARIS HAIR CANIS LUPUS FAMILIARIS HAIR 0.005 g CANIS LUPUS FAMILIARIS DANDER Canis lupus familiaris dander 0.005 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4824-2 10 in 1 VIAL 2 NDC:65044-4824-3 30 in 1 VIAL 3 NDC:65044-4824-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1976-08-24

Animal Allergens, Dog Hair and Dander Canis spp. Dog Hair Canis spp. INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-4083 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANIS LUPUS FAMILIARIS HAIR CANIS LUPUS FAMILIARIS HAIR 0.05 g CANIS LUPUS FAMILIARIS DANDER Canis lupus familiaris dander 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4083-2 10 in 1 VIAL 2 NDC:65044-4083-3 30 in 1 VIAL 3 NDC:65044-4083-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Animal Allergens, Dog Hair and Dander Canis spp. Dog Hair Canis spp. INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-4085 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANIS LUPUS FAMILIARIS HAIR CANIS LUPUS FAMILIARIS HAIR 0.05 g CANIS LUPUS FAMILIARIS DANDER Canis lupus familiaris dander 0.05 g Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4085-2 10 in 1 VIAL 2 NDC:65044-4085-3 30 in 1 VIAL 3 NDC:65044-4085-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Animal Allergens, Feather Mix Feather Mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-4349 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GALLUS GALLUS FEATHER GALLUS GALLUS FEATHER 0.1 g ANAS PLATYRHYNCHOS FEATHER ANAS PLATYRHYNCHOS FEATHER 0.1 g ANSER ANSER FEATHER ANAS PLATYRHYNCHOS FEATHER 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4349-2 10 in 1 VIAL 2 NDC:65044-4349-3 30 in 1 VIAL 3 NDC:65044-4349-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Animal Allergens, Feather Mix Feather Mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-4352 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GALLUS GALLUS FEATHER GALLUS GALLUS FEATHER 0.1 g ANAS PLATYRHYNCHOS FEATHER ANAS PLATYRHYNCHOS FEATHER 0.1 g ANSER ANSER FEATHER ANAS PLATYRHYNCHOS FEATHER 0.1 g Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4352-2 10 in 1 VIAL 2 NDC:65044-4352-3 30 in 1 VIAL 3 NDC:65044-4352-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Animal Allergens, Guinea Pig Hair and Dander Guinea Pig Hair and Dander INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-4401 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAVIA PORCELLUS HAIR Cavia porcellus hair 0.05 g CAVIA PORCELLUS DANDER Cavia porcellus dander 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4401-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Dust, House Mixture Dust, House Mixture INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-4700 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST HOUSE DUST 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4700-2 10 in 1 VIAL 2 NDC:65044-4700-3 30 in 1 VIAL 3 NDC:65044-4700-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Dust, House Mixture Dust, House Mixture INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-4703 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST HOUSE DUST 20000 [PNU] Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4703-2 10 in 1 VIAL 2 NDC:65044-4703-3 30 in 1 VIAL 3 NDC:65044-4703-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Dust, House Mixture Dust, House Mixture INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-4704 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST HOUSE DUST 10000 [PNU] Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4704-2 10 in 1 VIAL 2 NDC:65044-4704-3 30 in 1 VIAL 3 NDC:65044-4704-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

AP House Dust Mix AP House Dust Mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-4707 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST HOUSE DUST 20000 [PNU] Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4707-2 10 in 1 VIAL 2 NDC:65044-4707-3 30 in 1 VIAL 3 NDC:65044-4707-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1972-08-17

AP House Dust Mix AP House Dust Mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-4708 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST HOUSE DUST 20000 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4708-2 10 in 1 VIAL 2 NDC:65044-4708-3 30 in 1 VIAL 3 NDC:65044-4708-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1972-08-17

Food - Animal Products and Poultry Products, Beef Bovine spp. Beef Bovine spp. INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3077 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BEEF Beef 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3077-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Animal Products and Poultry Products, Chicken Meat Gallus sp. Chicken Meat Gallus sp. INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3173 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Poultry Poultry 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3173-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Animal Products and Poultry Products, Egg, White Gallus sp. Egg, White Gallus sp. INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3248 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EGG WHITE Egg White 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3248-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Animal Products and Poultry Products, Egg, Yolk Gallus sp. Egg, Yolk Gallus sp. INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3254 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EGG YOLK Egg Yolk 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3254-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Animal Products and Poultry Products, Pork Sus sp. Pork Sus sp. INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3509 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PORK Pork 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3509-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Dairy Products, Casein, Cow Milk Casein, Cow Milk INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3380 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CASEIN Casein 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3380-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Dairy Products, Milk, Whole Cow Milk, Whole Cow INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3389 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COW MILK COW MILK 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3389-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Fish and Shellfish, Clam Clam INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3191 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUAHOG, UNSPECIFIED Quahog, Unspecified 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3191-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Fish and Shellfish, Codfish Gadus callarias Codfish Gadus callarias INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3203 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COD, UNSPECIFIED Cod, Unspecified 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3203-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Fish and Shellfish, Crab Xiphosurus sowerbyi Crab Xiphosurus sowerbyi INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3215 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Crab Leg, Unspecified Crab Leg, Unspecified 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3215-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Fish and Shellfish, Lobster Homarus americanus Lobster Homarus americanus INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3362 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lobster, Unspecified Lobster, Unspecified 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3362-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Fish and Shellfish, Salmon Salmo salar Salmon Salmo salar INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3565 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALMON, UNSPECIFIED Salmon, Unspecified 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3565-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Fish and Shellfish, Shrimp Crago sp. Shrimp Crago sp. INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3584 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SHRIMP, UNSPECIFIED Shrimp, Unspecified 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3584-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Fish and Shellfish, Tuna Thunnus sp. Tuna Thunnus sp. INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3674 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TUNA, UNSPECIFIED Tuna, Unspecified 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3674-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Plant Source, Almond Prunus amygdalus Almond Prunus amygdalus INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3014 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALMOND 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3014-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Plant Source, Apple Malus sp. Apple Malus sp. INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3020 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength APPLE 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3020-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Plant Source, Banana Musa sapientum Banana Musa sapientum INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3041 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BANANA 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3041-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Plant Source, Brazil Nut Bertholletia excelsa Brazil Nut Bertholletia excelsa INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3107 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BRAZIL NUT Brazil Nut 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3107-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Plant Source, Carrot Daucus carota Carrot Daucus carota INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3125 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARROT 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3125-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Plant Source, Cashew Nut Anacardium occidentalie Cashew Nut Anacardium occidentalie INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3134 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CASHEW Cashew 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3134-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Plant Source, Celery Apium graveolens Celery Apium graveolens INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3140 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CELERY Celery 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3140-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Plant Source, Corn Zea mays Corn Zea mays INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3212 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CORN 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3212-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Plant Source, Hazelnut (Filbert) Corylus spp. Hazelnut (Filbert) Corylus spp. INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3305 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hazelnut, Unspecified Hazelnut, Unspecified 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3305-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Plant Source, Melon, Cantaloupe Cucumis melo Cantaloupe Cucumis melo INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3116 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANTALOUPE Cantaloupe 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3116-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Plant Source, Orange Citrus sinensis Orange Citrus sinensis INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3428 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ORANGE 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3428-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Plant Source, Pea, Green or English Pisum sativum Pea, Green or English Pisum sativum INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3449 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PEA 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3449-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Plant Source, Peach Prunus persica Peach Prunus persica INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3452 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PEACH Peach 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3452-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Plant Source, Peanut Arachis hypogaea Peanut Arachis hypogaea INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3455 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PEANUT Peanut 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3455-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Plant Source, Pecan Carya illinoensis Pecan Carya illinoensis INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3461 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECAN Pecan 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3461-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Plant Source, Potato, White Solanum tuberosum Potato, White Solanum tuberosum INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3518 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTATO Potato 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3518-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Plant Source, Rice, Whole Grain Rice, Whole Grain INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3548 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RICE RICE 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3548-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Plant Source, Rye Grain Rye Grain INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3554 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RYE 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3554-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Plant Source, Soybean Glycine soja Soybean Glycine soja INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3596 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOYBEAN 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3596-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Plant Source, Strawberry Fragaria chiloensis Strawberry Fragaria chiloensis INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3626 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Strawberry 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3626-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Plant Source, String Bean Mix String Bean Mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3074 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STRING BEAN String Bean 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3074-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Plant Source, Tomato Nicotiana spp. Tomato Nicotiana spp. INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3656 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOMATO 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3656-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Plant Source, Walnut, Black Juglans nigra Walnut, Black Juglans nigra INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3695 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLACK WALNUT Black Walnut 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3695-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Plant Source, Yeast, Baker Saccharomyces cerevisiae Yeast, Baker Saccharomyces cerevisiae INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3713 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength yeast 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3713-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Food - Plant Source, Yeast, Brewer Saccharomyces cerevisiae Yeast, Brewer Saccharomyces cerevisiae INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3716 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength yeast 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3716-2 10 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Insects (whole body) cockroach, American Periplaneta americana Insects (whole body) cockroach, American Periplaneta americana INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-6580 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERIPLANETA AMERICANA PERIPLANETA AMERICANA 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-6580-2 10 in 1 VIAL 2 NDC:65044-6580-3 30 in 1 VIAL 3 NDC:65044-6580-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Insects (whole body) Cockroach, German Blatella germanica Insects (whole body) Cockroach, German Blatella germanica INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-6581 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLATELLA GERMANICA BLATELLA GERMANICA 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-6581-2 10 in 1 VIAL 2 NDC:65044-6581-3 30 in 1 VIAL 3 NDC:65044-6581-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Insects (whole body) cockroach mix Insects (whole body) cockroach mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-6584 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERIPLANETA AMERICANA PERIPLANETA AMERICANA 0.1 g BLATELLA GERMANICA BLATELLA GERMANICA 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-6584-2 10 in 1 VIAL 2 NDC:65044-6584-3 30 in 1 VIAL 3 NDC:65044-6584-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Insects (whole body) cockroach mix Insects (whole body) cockroach mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-6587 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERIPLANETA AMERICANA PERIPLANETA AMERICANA 0.1 g BLATELLA GERMANICA BLATELLA GERMANICA 0.1 g Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-6587-2 10 in 1 VIAL 2 NDC:65044-6587-3 30 in 1 VIAL 3 NDC:65044-6587-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Insects (whole body) cockroach mix Insects (whole body) cockroach mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-6588 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERIPLANETA AMERICANA PERIPLANETA AMERICANA 20000 [PNU] BLATELLA GERMANICA BLATELLA GERMANICA 20000 [PNU] Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-6588-2 10 in 1 VIAL 2 NDC:65044-6588-3 30 in 1 VIAL 3 NDC:65044-6588-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Insects (whole body) cockroach mix Insects (whole body) cockroach mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-6589 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERIPLANETA AMERICANA PERIPLANETA AMERICANA 20000 [PNU] BLATELLA GERMANICA BLATELLA GERMANICA 20000 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-6589-2 10 in 1 VIAL 2 NDC:65044-6589-3 30 in 1 VIAL 3 NDC:65044-6589-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Insects (whole body) cockroach mix Insects (whole body) cockroach mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-6590 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERIPLANETA AMERICANA PERIPLANETA AMERICANA 5000 [PNU] BLATELLA GERMANICA BLATELLA GERMANICA 5000 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-6590-2 10 in 1 VIAL 2 NDC:65044-6590-3 30 in 1 VIAL 3 NDC:65044-6590-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Insects (whole body), Fire Ant Mix Insects (whole body), Fire Ant Mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-6518 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Solenopsis richteri Solenopsis richteri 0.1 g SOLENOPSIS INVICTA Solenopsis invicta 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-6518-2 10 in 1 VIAL 2 NDC:65044-6518-3 30 in 1 VIAL 3 NDC:65044-6518-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Insects (whole body), Fire Ant Mix Insects (whole body), Fire Ant Mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-6517 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Solenopsis richteri Solenopsis richteri 0.1 g SOLENOPSIS INVICTA Solenopsis invicta 0.1 g Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-6517-2 10 in 1 VIAL 2 NDC:65044-6517-3 30 in 1 VIAL 3 NDC:65044-6517-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds - Alternaria/Hormodendrum Mix Molds - Alternaria/Hormodendrum Mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5004 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA ALTERNARIA ALTERNATA 0.1 g CLADOSPORIUM CLADOSPORIOIDES CLADOSPORIUM CLADOSPORIOIDES 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5004-2 10 in 1 VIAL 2 NDC:65044-5004-3 30 in 1 VIAL 3 NDC:65044-5004-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds - Mold Mix 10 Molds - Mold Mix 10 INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5136 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA ALTERNARIA ALTERNATA 0.1 g ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS 0.025 g Aspergillus nidulans Aspergillus nidulans 0.025 g ASPERGILLUS NIGER VAR. NIGER Aspergillus Niger Var. Niger 0.025 g ASPERGILLUS TERREUS Aspergillus terreus 0.025 g FUSARIUM OXYSPORUM VASINFECTUM Fusarium oxysporum vasinfectum 0.1 g Dendryphiella vinosa Dendryphiella vinosa 0.1 g CLADOSPORIUM CLADOSPORIOIDES CLADOSPORIUM CLADOSPORIOIDES 0.1 g MUCOR RACEMOSUS mucor racemosus 0.1 g Penicillium digitatum Penicillium digitatum 0.02 g PENICILLIUM EXPANSUM Penicillium expansum 0.02 g PENICILLIUM EXPANSUM Penicillium expansum 0.02 g PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.02 g Clonostachys rosea f. rosea Clonostachys rosea f. rosea 0.02 g PHOMA EXIGUA VAR. EXIGUA Phoma exigua var. exigua 0.1 g AUREOBASIDIUM PULLULANS VAR. PULLUTANS AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.1 g RHIZOPUS STOLONIFER RHIZOPUS STOLONIFER 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5136-2 10 in 1 VIAL 2 NDC:65044-5136-3 30 in 1 VIAL 3 NDC:65044-5136-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds - Mold Mix 4 Molds - Mold Mix 4 INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5000 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA ALTERNARIA ALTERNATA 0.1 g ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS 0.025 g Aspergillus nidulans Aspergillus nidulans 0.025 g ASPERGILLUS NIGER VAR. NIGER Aspergillus Niger Var. Niger 0.025 g ASPERGILLUS TERREUS Aspergillus terreus 0.025 g CLADOSPORIUM CLADOSPORIOIDES CLADOSPORIUM CLADOSPORIOIDES 0.1 g Penicillium digitatum Penicillium digitatum 0.025 g PENICILLIUM EXPANSUM Penicillium expansum 0.025 g PENICILLIUM EXPANSUM Penicillium expansum 0.025 g PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.025 g Clonostachys rosea f. rosea Clonostachys rosea f. rosea 0.025 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5000-2 10 in 1 VIAL 2 NDC:65044-5000-3 30 in 1 VIAL 3 NDC:65044-5000-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds - Trichophyton Mix Molds - Trichophyton Mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5284 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHOPHYTON TONSURANS Trichophyton tonsurans 0.1 g TRICHOPHYTON RUBRUM Trichophyton rubrum 0.1 g TRICHOPHYTON MENTAGROPHYTES Trichophyton mentagrophytes 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5284-2 10 in 1 VIAL 2 NDC:65044-5284-3 30 in 1 VIAL 3 NDC:65044-5284-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Penicillium Mix Molds, Penicillium Mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5168 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Penicillium digitatum Penicillium digitatum 0.1 g PENICILLIUM EXPANSUM Penicillium expansum 0.1 g PENICILLIUM EXPANSUM Penicillium expansum 0.1 g PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.1 g Clonostachys rosea f. rosea Clonostachys rosea f. rosea 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5168-2 10 in 1 VIAL 2 NDC:65044-5168-3 30 in 1 VIAL 3 NDC:65044-5168-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Alternaria tenuis Alternaria tenuis INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5008 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA ALTERNARIA ALTERNATA 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5008-2 10 in 1 VIAL 2 NDC:65044-5008-3 30 in 1 VIAL 3 NDC:65044-5008-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5020 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5020-2 10 in 1 VIAL 2 NDC:65044-5020-3 30 in 1 VIAL 3 NDC:65044-5020-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Aspergillus niger Aspergillus niger INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5032 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS NIGER VAR. NIGER Aspergillus Niger Var. Niger 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5032-2 10 in 1 VIAL 2 NDC:65044-5032-3 30 in 1 VIAL 3 NDC:65044-5032-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Botrytis cinerea Botrytis cinerea INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5048 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOTRYTIS CINEREA BOTRYTIS CINEREA 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5048-2 10 in 1 VIAL 2 NDC:65044-5048-3 30 in 1 VIAL 3 NDC:65044-5048-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Candida albicans Candida albicans INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5052 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDIDA ALBICANS candida albicans 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5052-1 10 in 1 VIAL 2 NDC:65044-5052-3 30 in 1 VIAL 3 NDC:65044-5052-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Candida albicans Candida albicans INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5055 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDIDA ALBICANS candida albicans 0.001 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5055-1 10 in 1 VIAL 2 NDC:65044-5055-3 30 in 1 VIAL 3 NDC:65044-5055-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Cephalosporium acremonium Cephalosporium acremonium INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5056 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACREMONIUM STRICTUM Acremonium strictum 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5056-2 10 in 1 VIAL 2 NDC:65044-5056-3 30 in 1 VIAL 3 NDC:65044-5056-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Curvularia spicifera Curvularia spicifera INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5076 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCHLIOBOLUS SPICIFER Cochliobolus spicifer 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5076-2 10 in 1 VIAL 2 NDC:65044-5076-3 30 in 1 VIAL 3 NDC:65044-5076-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Epicoccum nigrum Epicoccum nigrum INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5100 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPICOCCUM NIGRUM EPICOCCUM NIGRUM 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5100-2 10 in 1 VIAL 2 NDC:65044-5100-3 30 in 1 VIAL 3 NDC:65044-5100-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Epidermophyton floccosum Epidermophyton floccosum INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5104 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPIDERMOPHYTON FLOCCOSUM Epidermophyton floccosum 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5104-2 10 in 1 VIAL 2 NDC:65044-5104-3 30 in 1 VIAL 3 NDC:65044-5104-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Fusarium vasinfectum Fusarium vasinfectum INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5112 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FUSARIUM OXYSPORUM VASINFECTUM Fusarium oxysporum vasinfectum 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5112-2 10 in 1 VIAL 2 NDC:65044-5112-3 30 in 1 VIAL 3 NDC:65044-5112-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Helminthosporium interseminatum Helminthosporium interseminatum INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5124 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dendryphiella vinosa Dendryphiella vinosa 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5124-2 10 in 1 VIAL 2 NDC:65044-5124-3 30 in 1 VIAL 3 NDC:65044-5124-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Hormodendrum cladosporioides Hormodendrum cladosporioides INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5128 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM CLADOSPORIOIDES CLADOSPORIUM CLADOSPORIOIDES 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5128-2 10 in 1 VIAL 2 NDC:65044-5128-3 30 in 1 VIAL 3 NDC:65044-5128-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Mucor racemosus Mucor racemosus INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5144 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUCOR RACEMOSUS mucor racemosus 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5144-2 10 in 1 VIAL 2 NDC:65044-5144-3 30 in 1 VIAL 3 NDC:65044-5144-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Penicillium notatum Penicillium notatum INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5208 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5208-2 10 in 1 VIAL 2 NDC:65044-5208-3 30 in 1 VIAL 3 NDC:65044-5208-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Phoma herbarum Phoma herbarum INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5220 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHOMA EXIGUA VAR. EXIGUA Phoma exigua var. exigua 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5220-2 10 in 1 VIAL 2 NDC:65044-5220-3 30 in 1 VIAL 3 NDC:65044-5220-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Pullularia pullulans Pullularia pullulans INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5235 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AUREOBASIDIUM PULLULANS VAR. PULLUTANS AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5235-2 10 in 1 VIAL 2 NDC:65044-5235-3 30 in 1 VIAL 3 NDC:65044-5235-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Rhizopus nigricans Rhizopus nigricans INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5230 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RHIZOPUS STOLONIFER RHIZOPUS STOLONIFER 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5230-2 10 in 1 VIAL 2 NDC:65044-5230-3 30 in 1 VIAL 3 NDC:65044-5230-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Stemphylium botryosum Stemphylium botryosum INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5264 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLEOSPORA TARDA PLEOSPORA TARDA 0.1 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5264-2 10 in 1 VIAL 2 NDC:65044-5264-3 30 in 1 VIAL 3 NDC:65044-5264-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Grasses, Bahia Grass Paspalum notatum Bahia Grass Paspalum notatum INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1081 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASPALUM NOTATUM POLLEN PASPALUM NOTATUM POLLEN 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1081-2 10 in 1 VIAL 2 NDC:65044-1081-3 30 in 1 VIAL 3 NDC:65044-1081-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Grasses, Bahia Grass Paspalum notatum Bahia Grass Paspalum notatum INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1084 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASPALUM NOTATUM POLLEN PASPALUM NOTATUM POLLEN 0.1 g Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1084-2 10 in 1 VIAL 2 NDC:65044-1084-3 30 in 1 VIAL 3 NDC:65044-1084-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Grasses, Brome, Smooth Bromus inermis Brome, Smooth Bromus inermis INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1237 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMUS INERMIS POLLEN BROMUS INERMIS POLLEN 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1237-2 10 in 1 VIAL 2 NDC:65044-1237-3 30 in 1 VIAL 3 NDC:65044-1237-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Grasses, Corn, Cultivated Zea mays Corn, Cultivated Zea mays INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1414 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZEA MAYS POLLEN ZEA MAYS POLLEN 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1414-2 10 in 1 VIAL 2 NDC:65044-1414-3 30 in 1 VIAL 3 NDC:65044-1414-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Grasses, Johnson Grass Sorghum halepense Johnson Grass Sorghum halepense INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1744 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SORGHUM HALEPENSE POLLEN SORGHUM HALEPENSE POLLEN 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1744-2 10 in 1 VIAL 2 NDC:65044-1744-3 30 in 1 VIAL 3 NDC:65044-1744-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Grasses, Johnson Grass Sorghum halepense Johnson Grass Sorghum halepense INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1747 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SORGHUM HALEPENSE POLLEN SORGHUM HALEPENSE POLLEN 0.1 g Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1747-2 10 in 1 VIAL 2 NDC:65044-1747-3 30 in 1 VIAL 3 NDC:65044-1747-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Grasses, Oats, Common, Cultivated Avena sativa Oats, Common, Cultivated Avena sativa INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-2041 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVENA SATIVA POLLEN AVENA SATIVA POLLEN 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2041-2 10 in 1 VIAL 2 NDC:65044-2041-3 30 in 1 VIAL 3 NDC:65044-2041-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Grasses, Grass Mix 8 Grass Mix 8 INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-0879 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POA PRATENSIS POLLEN POA PRATENSIS POLLEN 100000 [BAU] CYNODON DACTYLON POLLEN CYNODON DACTYLON POLLEN 10000 [BAU] SORGHUM HALEPENSE POLLEN SORGHUM HALEPENSE POLLEN 0.05 g AGROSTIS GIGANTEA POLLEN AGROSTIS GIGANTEA POLLEN 100000 [BAU] PHLEUM PRATENSE POLLEN PHLEUM PRATENSE POLLEN 100000 [BAU] Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-0879-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Grasses, Southern Grass Mix Pollens - Grasses, Southern Grass Mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-0854 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POA PRATENSIS POLLEN POA PRATENSIS POLLEN 100000 [BAU] DACTYLIS GLOMERATA POLLEN DACTYLIS GLOMERATA POLLEN 100000 [BAU] AGROSTIS GIGANTEA POLLEN AGROSTIS GIGANTEA POLLEN 100000 [BAU] PHLEUM PRATENSE POLLEN PHLEUM PRATENSE POLLEN 100000 [BAU] ANTHOXANTHUM ODORATUM POLLEN ANTHOXANTHUM ODORATUM POLLEN 100000 [BAU] SORGHUM HALEPENSE POLLEN SORGHUM HALEPENSE POLLEN 0.05 g CYNODON DACTYLON POLLEN CYNODON DACTYLON POLLEN 10000 [BAU] Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-0854-2 10 in 1 VIAL 2 NDC:65044-0854-3 30 in 1 VIAL 3 NDC:65044-0854-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Grasses, Southern Grass Mix 10th of concentrate Pollens - Grasses, Southern Grass Mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-0856 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POA PRATENSIS POLLEN POA PRATENSIS POLLEN 10000 [BAU] DACTYLIS GLOMERATA POLLEN DACTYLIS GLOMERATA POLLEN 10000 [BAU] AGROSTIS GIGANTEA POLLEN AGROSTIS GIGANTEA POLLEN 10000 [BAU] PHLEUM PRATENSE POLLEN PHLEUM PRATENSE POLLEN 10000 [BAU] ANTHOXANTHUM ODORATUM POLLEN ANTHOXANTHUM ODORATUM POLLEN 10000 [BAU] SORGHUM HALEPENSE POLLEN SORGHUM HALEPENSE POLLEN 0.005 g CYNODON DACTYLON POLLEN CYNODON DACTYLON POLLEN 1000 [BAU] Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-0856-2 10 in 1 VIAL 2 NDC:65044-0856-3 30 in 1 VIAL 3 NDC:65044-0856-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Acacia Acacia longifolia Acacia longifolia INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1006 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACACIA LONGIFOLIA POLLEN Acacia longifolia pollen 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1006-2 10 in 1 VIAL 2 NDC:65044-1006-3 30 in 1 VIAL 3 NDC:65044-1006-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Alder, Red Alnus rubra Alder, Red Alnus rubra INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1018 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALNUS RUBRA POLLEN ALNUS RUBRA POLLEN 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1018-2 10 in 1 VIAL 2 NDC:65044-1018-3 30 in 1 VIAL 3 NDC:65044-1018-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Alder, Red Alnus rubra Alder, Red Alnus rubra INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1021 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALNUS RUBRA POLLEN ALNUS RUBRA POLLEN 0.1 g Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1021-2 10 in 1 VIAL 2 NDC:65044-1021-3 30 in 1 VIAL 3 NDC:65044-1021-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Ash, White Fraxinus americana Ash, White Fraxinus americana INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1060 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS AMERICANA POLLEN FRAXINUS AMERICANA POLLEN 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1060-2 10 in 1 VIAL 2 NDC:65044-1060-3 30 in 1 VIAL 3 NDC:65044-1060-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Beech, American Fagus grandifolia Beech, American Fagus grandifolia INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1120 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAGUS GRANDIFOLIA POLLEN FAGUS GRANDIFOLIA POLLEN 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM CHLORIDE SODIUM BICARBONATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1120-2 10 in 1 VIAL 2 NDC:65044-1120-3 30 in 1 VIAL 3 NDC:65044-1120-4 50 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19