| Product NDC: | 65044-0879 |
| Proprietary Name: | Pollens - Grasses, Grass Mix 8 |
| Non Proprietary Name: | Grass Mix 8 |
| Active Ingredient(s): | 100000; 10000; 100000; 100000; .05 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL & nbsp; Grass Mix 8 |
| Administration Route(s): | PERCUTANEOUS; SUBCUTANEOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 65044-0879 |
| Labeler Name: | Jubilant HollisterStier LLC |
| Product Type: | NON-STANDARDIZED ALLERGENIC |
| FDA Application Number: | BLA103888 |
| Marketing Category: | BLA |
| Start Marketing Date: | 19410419 |
| Package NDC: | 65044-0879-4 |
| Package Description: | 50 mL in 1 VIAL (65044-0879-4) |
| NDC Code | 65044-0879-4 |
| Proprietary Name | Pollens - Grasses, Grass Mix 8 |
| Package Description | 50 mL in 1 VIAL (65044-0879-4) |
| Product NDC | 65044-0879 |
| Product Type Name | NON-STANDARDIZED ALLERGENIC |
| Non Proprietary Name | Grass Mix 8 |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | PERCUTANEOUS; SUBCUTANEOUS |
| Start Marketing Date | 19410419 |
| Marketing Category Name | BLA |
| Labeler Name | Jubilant HollisterStier LLC |
| Substance Name | AGROSTIS GIGANTEA POLLEN; CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN |
| Strength Number | 100000; 10000; 100000; 100000; .05 |
| Strength Unit | [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/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],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],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] |