Product NDC: | 65044-0842 |
Proprietary Name: | Standardized Grass Pollen, Grass Mix 4 |
Non Proprietary Name: | Standardized Grass Pollen, Grass Mix 4 |
Active Ingredient(s): | 25000; 25000; 25000; 25000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL & nbsp; Standardized Grass Pollen, Grass Mix 4 |
Administration Route(s): | PERCUTANEOUS; SUBCUTANEOUS |
Dosage Form(s): | INJECTION, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 65044-0842 |
Labeler Name: | Jubilant HollisterStier LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | BLA103873 |
Marketing Category: | BLA |
Start Marketing Date: | 19980115 |
Package NDC: | 65044-0842-1 |
Package Description: | 5 mL in 1 VIAL (65044-0842-1) |
NDC Code | 65044-0842-1 |
Proprietary Name | Standardized Grass Pollen, Grass Mix 4 |
Package Description | 5 mL in 1 VIAL (65044-0842-1) |
Product NDC | 65044-0842 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Standardized Grass Pollen, Grass Mix 4 |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | PERCUTANEOUS; SUBCUTANEOUS |
Start Marketing Date | 19980115 |
Marketing Category Name | BLA |
Labeler Name | Jubilant HollisterStier LLC |
Substance Name | AGROSTIS GIGANTEA POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN |
Strength Number | 25000; 25000; 25000; 25000 |
Strength Unit | [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL |
Pharmaceutical Classes | Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] |