Animal Allergens, AP Horse Hair and Dander description, usages, side effects, indications, overdosage, supplying and lots more!

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Animal Allergens, AP Horse Hair and Dander

Jubilant HollisterStier LLC
Jubilant HollisterStier LLC

INSTRUCTIONS ALLERGENIC EXTRACTS FOR SCRATCH, PRICK OR PUNCTURE TESTING


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

WARNINGS

This product is intended for use only by licensed medical personnel experienced in administering allergenic extracts and trained to provide immediate emergency treatment in the event of a life-threatening reaction. Allergenic extracts may potentially elicit a severe life threatening systemic reaction, rarely resulting in death.7 Therefore, emergency measures and personnel trained in their use must be available immediately in the event of such a reaction. Patients should be instructed to recognize adverse reaction s ymptoms and cautioned to contact the physician's office if symptoms occur. Patients on non-selective 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. This product should never be injected intravenously. Refer also to the WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS Sections for further discussion.

ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER DESCRIPTION

Sterile extracts for scratch, prick or puncture testing are supplied in dropper vials containing, in addition to the extract allergens and antigens, 50% (v/v) glycerin as preservative, 0.5% sodium chloride and 0.275% sodium bicarbonate. The strength of these extracts may be expressed in terms of

  • Weight to Volume (w/v)
  • Protein Nitrogen Units/mL (PNU/mL)
  • Allergy Units/mL (AU/mL)
  • Bioequivalent Allergy Units/mL (BAU/mL)
  • Concentrate

1. Weight to volume (w/v).
For regular extracts this describes the extraction ratio, i.e., the amount of crude allergen added to the extracting fluid. A 1:10 extract, therefore, indicates that the solution contains the extracted material from one gram of raw material added to each 10 mL of extracting fluid. The amount and composition of extracted materials will vary with the kind of antigen, the extracting fluid, duration of extraction, pH, temperature, and other variables. AP™ (acetone precipitated) extracts, if present, are prepared by reconstituting dry, allergenically active concentrates produced by precipitation process from extracts of raw materials. For those AP™ extracts labeled on a weight per volume (w/v) basis, the strength designation indicates the dry weight of finished (acetone) precipitate per volume of reconstituting fluid. For example, 1:50 (w/v) means that each gram of dry precipitate obtained from the original extract is reconstituted in 50 mL of solution.

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 reproducible from lot to lot. Also, the amount of protein nitrogen extracted from an antigen is influenced by the same variables as the weight to volume extract. Allergenic materials make up a variable proportion of the total protein of an extract.

3. Allergy Units per mL (AU/mL).
The potency of extracts labeled in Allergy Units per mL (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).

4. Bioequivalent Allergy Units per mL (BAU/mL).
When originally licensed, the Reference Preparations for standardized extracts were arbitrarily assigned 100,000 Allergy Units (AU)/mL. Subsequently, quantitative skin testing by the ID50EAL method 13 was used to determine that some Reference Preparations should be assigned 10,000 AU/mL, and others 100,000 AU/mL. To avoid possible confusion about this change in the method of allergy unit assignment, the nomenclature changed for standardized extracts whose allergy units are assigned based on quantitative skin testing, and such products are labeled in Bioequivalent Allergy Units (BAU)/mL. 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.

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

CLINICAL PHARMACOLOGY

Allergenic extracts for scratch, prick or puncture testing, used according to the DOSAGE AND ADMINISTRATION section, produce erythema or erythema and wheal reactions in patients with significant IgE-mediated sensitivity to the relevant allergen. This allergic inflammatory response, although not completely understood, is thought to begin with reaction of antigen with IgE on the surface of basophils or mast cells, which initiates a series of biochemical events resulting in the production of histamine and other mediators. These, in turn, produce the immediate-type "wheal and flare" skin reaction.

INDICATIONS & USAGE

Certain diagnostics carry labeling which states Allergenic Extract for Diagnostic Use Only. Data to support the therapeutic use of products labeled with this statement have not been established. 14
In addition to a carefully taken history, the use of glycerin-containing extracts in scratch, prick or puncture testing is an accepted method in the diagnosis of allergic conditions. 1, 2, 3 Extracts of all allergens do not produce equivalent results in scratch, prick or puncture tests. The intensity of the skin reactions produced will be determined by two factors: the degree of sensitivity of the patient, and the nature of the allergenic extract applied.
Scratch, prick or puncture tests are not as sensitive as the intradermal test, but are safer and cause less discomfort. They may, therefore, be the method of choice when a large number of tests are needed, or when testing the pediatric patient. In some cases, where the relatively insensitive scratch, prick or puncture tests are negative or do not confirm the allergic history, follow-up intradermal tests may be positive. However, ANTIGENS PRODUCING LARGE 3 to 4+ SCRATCH, PRICK OR PUNCTURE TESTS SHOULD NOT BE TESTED INTRADERMALLY.

ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER CONTRAINDICATIONS

There are no known absolute contraindications to allergy skin testing. Patients with cardiovascular diseases or pulmonary diseases such as symptomatic asthma, and/or 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 anaphylaxis treatment regimen.

WARNINGS

WARNINGS

PRECAUTIONS

1. General

Always have injectable epinephrine and a tourniquet available when tests are being made. (See ADVERSE REACTION section.) Generally 50 to 60 scratch, prick or puncture tests can be applied safely at one sitting. Patients whose history suggests severe sensitivity should have only 5 to 10 tests applied at a time and these tests applied to the volar surface of one arm. These tests should not all be of the same type of antigen; that is, all grass pollens, all weed pollens, all danders, etc. One or two tests from several classes of antigens should be applied at a time. As soon as a large wheal begins to develop, wipe the antigen from it with a damp cotton sponge. After 10 minutes wipe off all the antigens with a damp cotton sponge, followed by a dry cotton sponge. Be careful not to wipe antigen from a positive reaction onto an adjacent test site.

2 Information for Patients

Patients should be instructed in the recognition of adverse reactions to diagnostic testing. Patients should be made to understand the importance of a 30 minute observation period, and be warned to return to the office promptly if symptoms occur after leaving.

3. Drug Interactions

Patients on non-selective 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.6
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.9 Topical steroids should be discontinued at the skin test site for at least 2-3 weeks before skin testing.9, 10 Tricyclic antidepressants such as Doxepin should be withheld for at least 7 days before skin testing.11 Topical local anesthetics may suppress the flare responses and should be
avoided in skin test sites.12

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

4,5
Pregnancy Category C. Animal reproduction studies have not been conducted with allergenic extracts. It is also not known whether allergenic extracts can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Allergenic extracts should be given to a pregnant woman only if clearly needed.

6. Nursing Mothers

There are no current studies on secretion of the allergenic extract components in human milk or 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

Wheal sizes in response to allergen skin testing can be smaller in infants than in adults. The skin response to histamine parallels that for allergens; therefore, appropriate positive control skin tests should always be performed.1

8. Geriatric Use

Skin test wheal size decreases with age. The decrease in allergen-induced skin test reaction parallels that to histamine; therefore, appropriate positive skin test controls should always be performed.1

ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER ADVERSE REACTIONS

1. Local Reactions


2. Systemic Reactions

7, 8
If a systemic or anaphylactic reaction does occur, WIPE OFF test antigen, apply a tourniquet above the site of injection, if tests are performed on the arms, and inject the 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:
ADULT DOSAGE:
PEDIATRIC DOSAGE


3. Adverse Event Reporting

OVERDOSAGE

See ADVERSE REACTIONS Section.

DOSAGE & ADMINISTRATION

1. General
Parenteral Drug Products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

2. Scratch, Prick or Puncture Testing Methods
There are two general methods of skin testing. (1) The skin is scarified first, and the extract is then applied. (2) A drop of extract is put onto the skin, and a prick or puncture is made through the drop. Avoid touching tip of dropper to skin. Either method is satisfactory, but the second requires that the instrument be cleansed between tests or that separate needles be used.

The extracts for scratch, prick or puncture testing are supplied in dropper vials and should be kept in a rack or box in rows of 10 vials corresponding to the rows of tests to be applied to the skin.

All skin tests should be validated by appropriate positive control tests (e.g., histamine) and negative control tests (e.g., Glycerin, Albumin Saline with Phenol (0.4%), or Buffered Saline with Phenol). The negative control test should be the same material as is used as a diluting fluid in the tested extracts. Diluting fluid is used in the same way as an active test extract.

Test sites should be examined at 15 and 30 minutes. To prevent excessive absorption, wipe off antigens producing large reactions as soon as the wheal appears. Record the size of the reaction. Delayed reactions may rarely occur from tests, so it may be helpful to examine the test sites in 24 hours.

Use of Scarifiers and Spacing. Make scarifications at least 2.5 cm apart. Use more space between pollen tests to prevent smearing into adjacent sites. Hold the scarifier between the thumb and index finger, press the sharp edge of the instrument against the skin and twirl instrument rapidly. The scratch should disrupt only the outer layers of epidermis but should not produce immediate oozing of blood. The amount of pressure needed to produce a satisfactory scratch will vary between patients according to the thickness or fragility of their skin. Experience will indicate the proper amount of pressure to exert in making the scratch. If the scarifier is kept sharp and the scratch made quickly, discomfort to the patient is minimized.

Use of Prick Test Needles. The skin is cleaned and single drops of each extract applied to the properly identified test sites. A small, sterile disposable needle, such as a 1/2-inch 26 gauge needle (with the bevel up), a bifurcated vaccinating needle, or a Prick Lancetter™ is inserted through the drop superficially into the skin, the skin lifted slightly and the needle withdrawn. No bleeding should be produced. After about 1 minute the extract may be wiped away.

3. Most Satisfactory Sites for Testing
Prior to testing, clean the skin area to be tested with ether or alcohol and allow to dry. Use a sterile instrument for each patient. The back or the volar surface of the arms are the most satisfactory sites for testing. Skin of the posterior thighs or abdomen may be used if necessary. Avoid very hairy areas where possible, since the reactions will be smaller and more difficult to interpret. The most satisfactory areas of the back are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins. The best areas of the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anti-cubital space.

4. Use of Antigen Mixes
The use of complicated mixes of unrelated pollens for testing is not recommended since in the case of a positive reaction, it does not indicate which pollen(s) are responsible, and, in the case of a negative reaction, it fails to indicate whether the individual pollens at full concentration would give a positive reaction.

5. Reading Skin Test Reactions
A positive reaction consists of an urticarial wheal with surrounding erythema (resembling somewhat a mosquito bite reaction) larger than the control site. The smallest reaction considered positive is erythema with a central papule at least 5 mm in diameter. In some instances with no reaction at the control site, erythema may be considered an indication of sensitivity. In general, the size of wheal and erythema response correlates directly with the patient’s sensitivity to that allergen.

Standardized Products
(a) Mites
:
The skin test concentration of 30,000 AU/mL in dropper vials is used for scratch, prick or puncture testing. Puncture tests performed on 12 highly sensitive subjects showed the following:

Species
Mean Sum of Wheal
± Std. Dev. (mm)
Mean Sum of Erythema
± Std. Dev. (mm)
D. farinae
22.4 ± 10.7
82.2 ± 21.7
D. pteronyssinus
24.0 ± 9.9
89.3 ± 24.5

The sum of a skin response is the sum of the longest diameter and the mid-point orthogonal diameter.

(b) Cat Hair and Cat Pelt: The skin test concentration of 10,000 BAU/mL (10-19.9 Fel d 1 Units/mL) in dropper vials is used for prick or puncture testing. Puncture tests performed on 15 highly sensitive subjects showed the following:

Product
Mean Sum of Wheal
± Std. Dev (mm)
Mean Sum of Erythema
± Std. Dev (mm)
Standardized
Cat Hair
15.1 ± 3.8
73.3 ± 14.3
Standardized
Cat Pelt
13.9 ± 4.3
67.3 ± 13.3

The sum of a skin response is the sum of the longest diameter and the mid-point orthogonal diameter.

(c) Ragweed pollen (Short Ragweed or Giant and Short Ragweed Mixture) Antigen E Assayed: Short Ragweed extract at 1:20 w/v in 50% glycerin containing approximately 100 to 300 units of Antigen E/mL or Giant and Short Ragweed Mix at 1:20 w/v in 50% glycerin containing approximately 50 to 150 units of Antigen E/mL are usually used for scratch, prick or puncture testing.
Refer to the following table to determine the skin test sensitivity grade. The corresponding ∑E (sum of the longest diameter and the mid-point orthogonal diameters of erythema) is also presented.

Grade
Erythema
mm
Papule or Wheal
mm
Corresponding
mm ∑E
0
<5
<5
<10
± 5-10
5-10
10-20
1+
11-20
5-10
20-40
2+
21-30
5-10
40-60
3+
31-40
10-15 (a)
60-80
4+
>40
>15 (b)
>80

A positive skin reaction to any allergen must be interpreted in light of the patient’s history of symptoms, time of the year, known exposures, and eating habits.
THE SKIN TESTS ARE IN NO WAY A SUBSTITUTE FOR A CAREFUL ALLERGIC HISTORY. THEY SERVE AS ADDITIONAL INFORMATION TO AID IN IDENTIFYING CAUSATIVE ALLERGENS IN PATIENTS WITH ALLERGIC DISORDERS.

6. Geriatric Use


The dose is the same in patients of all age groups. Because the wheal size in response to allergen skin testing decreases with age, appropriate histamine positive control skin tests must be performed.1

7. Pediatric Use


The dose is the same in patients of all age groups. Wheal size in response to allergen skin testing can be smaller in infants than in adults. Appropriate histamine positive control skin tests must be performed.1

HOW SUPPLIED


STORAGE

The expiration date of the diagnostic extracts is listed on the container label. The extract should be stored at 2° - 8°C and kept at this temperature range during office use.

LIMITED WARRANTY

REFERENCES

1. Middleton, Elliott, Jr., C.E. Reed, E.F. Ellis (ed.) Allergy Principles and Practice. Fourth Edition, Vol. 1. C.V. Mosby. 1993.
2. Sheldon, J.M., R.G. Lovell, K.P. Mathews. A Manual of Clinical Allergy. W.B. Saunders. 1967.
3. Tuft, L., H.L. Mueller. Allergy in Children. W.B. Saunders. 1970.
4. DuBuske, L.M., C.J. Ling, A.L. Sheffer. Special problems regarding allergen immunotherapy. Immunol. Allergy Clin. North Am. (USA). 12(1): 145-175, 1992.
5. Weinstein, A.M., B.D. Dubin, W.K. Podleski, S.L. Spector, R.S. Farr. Asthma and pregnancy. JAMA. 124(11): 1161-1165, 1979.
6. Jacobs, Robert L., Geoffrey W. Rake, Jr., et.al. Potentiated anaphylaxis in patients with drug-induced beta-adrenergic blockade. J. Allergy Clin. Immunol. 68(2): 125-127, August 1981.
7. Lockey, Richard F., Linda M. Benedict, Paul C. Turkeltaub, Samuel C. Bukantz. Fatalities from immunotherapy (IT) and skin testing (ST). J. Allergy Clin. Immunol. 79(4): 660-677, 1987.
8. Turkeltaub, Paul C., Peter J. Gergen. The risk of adverse reactions from percutaneous prick-puncture allergen skin testing, venipuncture, and body measurements: Data from the second National Health and Nutrition Examination Survey 1976-80 (NHANES II). J. Allergy Clin. Immunol. 84(6): 886-890, Dec. 1989.
9. Pipkorn, Ulf. Pharmacological influence of anti-allergic medication on In Vivo allergen testing. Allergy. 43: 81-86, 1988.
10. Andersson, M., U. Pipkorn. Inhibition of the dermal immediate allergic reaction through prolonged treatment with topical glucocorticosteroids. J. Allergy Clin. Immunol. 79 (2): 345-349, February 1987.
11. Rao, Kamineni S., et al. Duration of suppressive effect of tricyclic anti-depressants on histamine induced wheal and flare reactions on human skin. J. Allergy Clin. Immunol. 82: 752-757, November 1988.
12. Pipkorn, Ulf, M. Andersson. Topical dermal anesthesia inhibits the flare but not the wheal response to allergen and histamine in the skin prick test. Clin. Allergy. 17: 307-311, 1987.
13. Turkeltaub, Paul C., Suresh, C. Rastogi, Harold Baer. Office of Biologics Research and Review skin test method for evaluation of subject sensitivity to standardized allergenic extracts and for assignment of allergy units to reference preparations using the ID50EAL method (Intradermal Dilution for 50 mm Sum of Erythema Determines the Allergy Unit). Methods of the Allergenic Products Branch Office of Biologics Research and Review, FDA, Bethesda, MD 20892. Revised May 9, 1986.
14. Food and Drug Administration. Biological products; Allergenic extracts classified in Category IIIB; Final order; Revocation of licenses. Federal Register. 59(220): 59228ff, November 16, 1994.


Animal Allergens, AP Horse Hair and Dander

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:65044-4856
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:65044-4856-1 5 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:65044-4812
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:65044-4812-1 5 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:65044-4825
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:65044-4825-1 5 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:65044-4084
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:65044-4084-1 5 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:65044-4350
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:65044-4350-1 5 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:65044-4402
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:65044-4402-1 5 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:65044-4705
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:65044-4705-1 5 in 1 VIAL

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 1972-08-17


Dust, House Mixture

Dust, House Mixture INJECTION, SOLUTION

Product Information

Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-4701
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:65044-4701-1 5 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, Beef Bovine spp.

Beef Bovine spp. INJECTION, SOLUTION

Product Information

Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-3078
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:65044-3078-1 5 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:65044-3174
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:65044-3174-1 5 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:65044-3249
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:65044-3249-1 5 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:65044-3255
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:65044-3255-1 5 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:65044-3510
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:65044-3510-1 5 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:65044-3381
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:65044-3381-1 5 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:65044-3390
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:65044-3390-1 5 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:65044-3192
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:65044-3192-1 5 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:65044-3204
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:65044-3204-1 5 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:65044-3216
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:65044-3216-1 5 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:65044-3363
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:65044-3363-1 5 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:65044-3564
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:65044-3564-1 5 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:65044-3585
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:65044-3585-1 5 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:65044-3675
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:65044-3675-1 5 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:65044-3015
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:65044-3015-1 5 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:65044-3021
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:65044-3021-1 5 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:65044-3042
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:65044-3042-1 5 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:65044-3108
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:65044-3108-1 5 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:65044-3126
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:65044-3126-1 5 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:65044-3135
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:65044-3135-1 5 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:65044-3141
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:65044-3141-1 5 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:65044-3213
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:65044-3213-1 5 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:65044-3306
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:65044-3306-1 5 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:65044-3117
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:65044-3117-1 5 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:65044-3429
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:65044-3429-1 5 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:65044-3450
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:65044-3450-1 5 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:65044-3453
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:65044-3453-1 5 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:65044-3456
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:65044-3456-1 5 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:65044-3462
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:65044-3462-1 5 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:65044-3519
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:65044-3519-1 5 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:65044-3549
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:65044-3549-1 5 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:65044-3555
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:65044-3555-1 5 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:65044-3597
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:65044-3597-1 5 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:65044-3627
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:65044-3627-1 5 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:65044-3075
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:65044-3075-1 5 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:65044-3657
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:65044-3657-1 5 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:65044-3696
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:65044-3696-1 5 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:65044-3714
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:65044-3714-1 5 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:65044-3717
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:65044-3717-1 5 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:65044-6585
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:65044-6585-1 5 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), Ant, Fire Solenopsis Invicta

Ant, Fire Solenopsis Invicta INJECTION, SOLUTION

Product Information

Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-6513
Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
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:65044-6513-1 5 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), Ant, Fire Solenopsis richteri

Ant, Fire Solenopsis richteri INJECTION, SOLUTION

Product Information

Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-6514
Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Solenopsis richteri Solenopsis richteri 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:65044-6514-1 5 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:65044-6515
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:65044-6515-1 5 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:65044-5003
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:65044-5003-1 5 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:65044-5137
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 0.04 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:65044-5137-1 5 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:65044-5002
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 0.05 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:65044-5002-1 5 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:65044-5285
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:65044-5285-1 5 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:65044-5169
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 0.2 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:65044-5169-1 5 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:65044-5009
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:65044-5009-1 5 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:65044-5021
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:65044-5021-1 5 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:65044-5033
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:65044-5033-1 5 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:65044-5049
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:65044-5049-1 5 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:65044-5053
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:65044-5053-1 5 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:65044-5057
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:65044-5057-1 5 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:65044-5077
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:65044-5077-1 5 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:65044-5101
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:65044-5101-1 5 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:65044-5105
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:65044-5105-1 5 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:65044-5113
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:65044-5113-1 5 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:65044-5125
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:65044-5125-1 5 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:65044-5129
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:65044-5129-1 5 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:65044-5145
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:65044-5145-1 5 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:65044-5209
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:65044-5209-1 5 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:65044-5221
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:65044-5221-1 5 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:65044-5233
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:65044-5233-1 5 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:65044-5232
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:65044-5232-1 5 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:65044-5265
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:65044-5265-1 5 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:65044-1082
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:65044-1082-1 5 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:65044-1238
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:65044-1238-1 5 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:65044-1415
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:65044-1415-1 5 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:65044-1745
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:65044-1745-1 5 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:65044-2042
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:65044-2042-1 5 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:65044-0855
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:65044-0855-1 5 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:65044-0857
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:65044-0857-1 5 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:65044-1007
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:65044-1007-1 5 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:65044-1019
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:65044-1019-1 5 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:65044-1061
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:65044-1061-1 5 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:65044-1121
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:65044-1121-1 5 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, Birch Mix

Birch Mix INJECTION, SOLUTION

Product Information

Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1169
Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BETULA PAPYRIFERA POLLEN BETULA PAPYRIFERA POLLEN 0.05 g
BETULA PENDULA POLLEN Betula pendula pollen 0.05 g
BETULA NIGRA POLLEN BETULA NIGRA 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:65044-1169-1 5 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, Bottlebrush, Callistemon spp.

Bottlebrush, Callistemon citrinus INJECTION, SOLUTION

Product Information

Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1208
Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Callistemon citrinus pollen CALLISTEMON CITRINUS 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:65044-1208-1 5 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, Boxelder/Maple Mix

Boxelder/Maple Mix INJECTION, SOLUTION

Product Information

Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1214
Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACER NEGUNDO POLLEN ACER NEGUNDO POLLEN 0.05 g
ACER SACCHARUM POLLEN ACER SACCHARUM POLLEN 0.05 g
ACER RUBRUM POLLEN ACER RUBRUM 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:65044-1214-1 5 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, Cedar, Mountain Juniperus ashei

Cedar, Mountain Juniperus ashei INJECTION, SOLUTION

Product Information

Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1337
Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
JUNIPERUS ASHEI POLLEN JUNIPERUS ASHEI 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:65044-1337-1 5 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, Cedar, Red Juniperus virginiana

Cedar, Red Juniperus virginiana INJECTION, SOLUTION

Product Information

Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1340
Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
JUNIPERUS VIRGINIANA POLLEN JUNIPERUS VIRGINIANA 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:65044-1340-1 5 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, Cottonwood, Common Populus deltoides

Cottonwood, Common Populus deltoides INJECTION, SOLUTION

Product Information

Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1436
Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
POPULUS DELTOIDES POLLEN POPULUS DELTOIDES 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:65044-1436-1 5 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, Cypress, Arizona Cupressus arizonica

Cypress, Arizona Cupressus arizonica INJECTION, SOLUTION

Product Information

Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1451
Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CUPRESSUS ARIZONICA POLLEN CUPRESSUS ARIZONICA 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:65044-1451-1 5 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, Cypress, Bald Taxodium distichum

Cypress, Bald Taxodium distichum INJECTION, SOLUTION

Product Information

Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1454
Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
TAXODIUM DISTICHUM POLLEN TAXODIUM DISTICHUM POLLEN 0.02 g

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
SODIUM CHLORIDE
SODIUM BICARBONATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65044-1454-1 5 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, Elm, American Ulmus americana

Elm, American Ulmus americana INJECTION, SOLUTION

Product Information

Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1541
Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ULMUS AMERICANA POLLEN ULMUS 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:65044-1541-1 5 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, Elm, Chinese Ulmus parvifolia

Elm, Chinese Ulmus parvifolia INJECTION, SOLUTION

Product Information

Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1547
Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Ulmus parvifolia pollen Ulmus parvifolia 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:65044-1547-1 5 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, Eucalyptus (Blue Gum) Eucalyptus globulus

Eucalyptus (Blue Gum) Eucalyptus globulus INJECTION, SOLUTION

Product Information

Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1565
Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
EUCALYPTUS GLOBULUS POLLEN EUCALYPTUS GLOBULUS 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:65044-1565-1 5 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, Gum, Sweet Liquidambar styraciflua

Gum, Sweet Liquidambar styraciflua INJECTION, SOLUTION

Product Information

Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1661
Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LIQUIDAMBAR STYRACIFLUA POLLEN LIQUIDAMBAR STYRACIFLUA 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:65044-1661-1 5 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, Hackberry Celtis occidentalis

Hackberry Celtis occidentalis INJECTION, SOLUTION

Product Information

Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1664
Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CELTIS OCCIDENTALIS POLLEN CELTIS OCCIDENTALIS 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:65044-1664-1 5 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, Hickory, Shagbark Carya ovata

Hickory, Shagbark Carya ovata INJECTION, SOLUTION

Product Information

Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1703
Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CARYA OVATA POLLEN CARYA OVATA 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:65044-1703-1 5 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, Linden (Basswood) Tilia americana

Linden (Basswood) Tilia americana INJECTION, SOLUTION

Product Information

Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1802
Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
TILIA AMERICANA POLLEN Tilia 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:65044-1802-1 5 in 1 VIAL

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 1941-04-19


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