| Product NDC: | 54575-913 |
| Proprietary Name: | BIRCH MIX, RIVER/PAPER/SWEET/WHITE POLLEN |
| Non Proprietary Name: | betula nigra pollen and betula papyrifera pollen and betula lenta pollen and betula populifolia pollen |
| Active Ingredient(s): | .25; .25; .25; .25 g/20mL; g/20mL; g/20mL; g/20mL & nbsp; betula nigra pollen and betula papyrifera pollen and betula lenta pollen and betula populifolia pollen |
| Administration Route(s): | PERCUTANEOUS; SUBCUTANEOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 54575-913 |
| Labeler Name: | Allergy Laboratories, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | BLA101376 |
| Marketing Category: | BLA |
| Start Marketing Date: | 19671207 |
| Package NDC: | 54575-913-30 |
| Package Description: | 30 mL in 1 VIAL, MULTI-DOSE (54575-913-30) |
| NDC Code | 54575-913-30 |
| Proprietary Name | BIRCH MIX, RIVER/PAPER/SWEET/WHITE POLLEN |
| Package Description | 30 mL in 1 VIAL, MULTI-DOSE (54575-913-30) |
| Product NDC | 54575-913 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | betula nigra pollen and betula papyrifera pollen and betula lenta pollen and betula populifolia pollen |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | PERCUTANEOUS; SUBCUTANEOUS |
| Start Marketing Date | 19671207 |
| Marketing Category Name | BLA |
| Labeler Name | Allergy Laboratories, Inc. |
| Substance Name | BETULA LENTA POLLEN; BETULA NIGRA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA POPULIFOLIA POLLEN |
| Strength Number | .25; .25; .25; .25 |
| Strength Unit | g/20mL; g/20mL; g/20mL; g/20mL |
| Pharmaceutical Classes | Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] |