| Product NDC: | 65044-0847 |
| Proprietary Name: | Standardized Grass Pollen, Grass Mix 5 |
| Non Proprietary Name: | Standardized Grass Pollen, Grass Mix 5 |
| Active Ingredient(s): | 20; 20; 20; 20; 20 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL & nbsp; Standardized Grass Pollen, Grass Mix 5 |
| Administration Route(s): | INTRADERMAL |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 65044-0847 |
| Labeler Name: | Jubilant HollisterStier LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | BLA103873 |
| Marketing Category: | BLA |
| Start Marketing Date: | 19980115 |
| Package NDC: | 65044-0847-5 |
| Package Description: | 5 mL in 1 VIAL (65044-0847-5) |
| NDC Code | 65044-0847-5 |
| Proprietary Name | Standardized Grass Pollen, Grass Mix 5 |
| Package Description | 5 mL in 1 VIAL (65044-0847-5) |
| Product NDC | 65044-0847 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Standardized Grass Pollen, Grass Mix 5 |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRADERMAL |
| Start Marketing Date | 19980115 |
| Marketing Category Name | BLA |
| Labeler Name | Jubilant HollisterStier LLC |
| Substance Name | AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN |
| Strength Number | 20; 20; 20; 20; 20 |
| Strength Unit | [BAU]/mL; [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],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] |