Bahia Grass (Page 3 of 3)

HOW SUPPLIED

Allergenic extracts are supplied with units listed as: Weight/volume (W/V), Protein Nitrogen Units (PNU/ml), Allergy Units (AU/ml) or Bioequivalent Allergy Units (BAU/ml).

Sizes:

Diagnostic Scratch: 5 ml dropper application vials

Diagnostic Intradermal: 5 ml or 10 ml vials.

Therapeutic Allergens: 5 ml, 10 ml, 50 ml multiple dose vials.

STORAGE

The expiration date of allergen extracts is listed on the container label. Store extracts upon arrival at 2° to 8°C and keep them in this range during office use.

WARRANTY: We warrant that this product was prepared and tested according to the standards of the FDA and is true to label. Because of biological differences in individuals and because allergenic extracts are manufactured to be potent and because we have no control over the conditions of use, we cannot and do not warrant either a good effect or against an ill effect following use.

REFERENCES

1 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.

2 Ishizaka,K.: Cellular Events in the IgE Antibody Response. Adv. in Immuno. 23:50-75, 1976.

3. Lockey, R.F., Bukantz, S.C., Allergen Immunotherapy. New York,NY: Marcel Dekker Inc., 1991.

4. Reid,M.J., Lockey,R.F., Turkeltaub,P.C., Platts-Mills,T.A.E., Survey of fatalities from skin testing and immunotherapy 1985-1989. Journal of Allergy Clin. Immunol. 92 (1): 6-15, July 1993.

5. Murray, A.B., Ferguson, A., Morrison, B., The frequency and severity of cat allergy vs dog allergy in atopic children. J. Allergy Clin. Immunolo: 72, 145-9, 1983.

6. Lockey, R.F., Bukantz, S.C., Allergen Immunotherapy. New York,NY: Marcel Dekker Inc., 1991.

CONTAINER LABELING

5 mL Stock Concentrate Scratch
(click image for full-size original)
5 mL Stock Concentrate Intradermal
(click image for full-size original)
Stock Concentrate Small Label
(click image for full-size original)
Stock Concentrate Large Label
(click image for full-size original)
BAHIA GRASS bahia grass injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2262
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PASPALUM NOTATUM POLLEN (PASPALUM NOTATUM POLLEN) PASPALUM NOTATUM POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
WATER
PHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2262-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2262-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2262-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2262-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
ANNUAL BLUE GRASS annual blue grass injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2271
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POA ANNUA POLLEN (POA ANNUA POLLEN) POA ANNUA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
WATER
PHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2271-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2271-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2271-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2271-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
CANADIAN BLUE GRASS canadian blue grass injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2279
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POA COMPRESSA POLLEN (POA COMPRESSA POLLEN) POA COMPRESSA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
WATER
PHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2279-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2279-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2279-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2279-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
BROME GRASS brome grass injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2287
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROMUS INERMIS POLLEN (BROMUS INERMIS POLLEN) BROMUS INERMIS POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
WATER
PHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2287-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2287-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2287-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2287-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
CANARY GRASS canary grass injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2295
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHALARIS ARUNDINACEA POLLEN (PHALARIS ARUNDINACEA POLLEN) PHALARIS ARUNDINACEA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
WATER
PHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2295-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2295-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2295-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2295-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
CORN GRASS corn grass injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2303
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZEA MAYS POLLEN (ZEA MAYS POLLEN) ZEA MAYS POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
WATER
PHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2303-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2303-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2303-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2303-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
COUCH QUACK GRASS couch quack grass injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2311
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ELYMUS REPENS POLLEN (ELYMUS REPENS POLLEN) ELYMUS REPENS POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
WATER
PHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2311-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2311-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2311-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2311-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
GRAMA GRASS grama grass injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2321
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOUTELOUA GRACILIS POLLEN (BOUTELOUA GRACILIS POLLEN) BOUTELOUA GRACILIS POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
WATER
PHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2321-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2321-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2321-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2321-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
JOHNSON GRASS johnson grass injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2329
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SORGHUM HALEPENSE POLLEN (SORGHUM HALEPENSE POLLEN) SORGHUM HALEPENSE POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
WATER
PHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2329-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2329-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2329-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2329-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
CULTIVATED OAT cultivated oat injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2337
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVENA SATIVA POLLEN (AVENA SATIVA POLLEN) AVENA SATIVA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
WATER
PHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2337-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2337-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2337-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2337-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
QUACK GRASS quack grass injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2355
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ELYMUS REPENS POLLEN (ELYMUS REPENS POLLEN) ELYMUS REPENS POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
WATER
PHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2355-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2355-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2355-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2355-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
CULTIVATED RYE cultivated rye injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2365
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SECALE CEREALE POLLEN (SECALE CEREALE POLLEN) SECALE CEREALE POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
PHENOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2365-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2365-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2365-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2365-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
GIANT WILD RYE giant wild rye injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2373
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEYMUS CONDENSATUS POLLEN (LEYMUS CONDENSATUS POLLEN) LEYMUS CONDENSATUS POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
PHENOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2373-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2373-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2373-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2373-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
ITALIAN RYE GRASS italian rye grass injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2381
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOLIUM PERENNE SSP. MULTIFLORUM POLLEN (LOLIUM PERENNE SSP. MULTIFLORUM POLLEN) LOLIUM PERENNE SSP. MULTIFLORUM POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
PHENOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2381-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2381-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2381-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2381-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
SALT GRASS salt grass injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2391
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DISTICHLIS SPICATA POLLEN (DISTICHLIS SPICATA POLLEN) DISTICHLIS SPICATA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
PHENOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2391-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2391-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2391-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2391-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
VELVET GRASS velvet grass injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2403
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DISTICHLIS SPICATA POLLEN (DISTICHLIS SPICATA POLLEN) DISTICHLIS SPICATA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
PHENOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2403-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2403-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2403-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2403-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
CULTIVATED WHEAT cultivated wheat injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2411
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRITICUM AESTIVUM POLLEN (TRITICUM AESTIVUM POLLEN) TRITICUM AESTIVUM POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
PHENOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2411-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2411-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2411-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2411-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
WEST WHEAT GRASS west wheat grass injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2419
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PASCOPYRUM SMITHII POLLEN (PASCOPYRUM SMITHII POLLEN) PASCOPYRUM SMITHII POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
PHENOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2419-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2419-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2419-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2419-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
SOFT CHEAT BROME soft cheat brome injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2429
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROMUS INERMIS POLLEN (BROMUS INERMIS POLLEN) BROMUS INERMIS POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
PHENOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2429-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2429-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2429-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2429-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
SMOOTH BROME smooth brome injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2437
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROMUS INERMIS POLLEN (BROMUS INERMIS POLLEN) BROMUS INERMIS POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
PHENOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2437-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2437-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2437-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2437-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 08/29/1972
Labeler — Nelco Laboratories, Inc. (054980867)
Registrant — Nelco Laboratories, Inc. (054980867)
Establishment
Name Address ID/FEI Operations
Nelco Laboratories, Inc. 054980867 manufacture

Revised: 12/2009 Nelco Laboratories, Inc.

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