Standardized Grass Pollen, Grass Mix 5 is a Intradermal Injection, Solution in the Standardized Allergenic category. It is labeled and distributed by Jubilant Hollisterstier Llc. The primary component is Poa Pratensis Pollen; Dactylis Glomerata Pollen; Agrostis Gigantea Pollen; Phleum Pratense Pollen; Anthoxanthum Odoratum Pollen.
Product ID | 65044-0848_d35f56c5-a667-4175-83dc-963235f74ab6 |
NDC | 65044-0848 |
Product Type | Standardized Allergenic |
Proprietary Name | Standardized Grass Pollen, Grass Mix 5 |
Generic Name | Standardized Grass Pollen, Grass Mix 5 |
Dosage Form | Injection, Solution |
Route of Administration | INTRADERMAL |
Marketing Start Date | 1998-01-15 |
Marketing Category | BLA / BLA |
Application Number | BLA103873 |
Labeler Name | Jubilant HollisterStier LLC |
Substance Name | POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN |
Active Ingredient Strength | 200 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL |
Pharm Classes | Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS] |
NDC Exclude Flag | N |
Listing Certified Through | 2019-12-31 |
Marketing Start Date | 1998-01-15 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | BLA |
Application Number | BLA103873 |
Product Type | STANDARDIZED ALLERGENIC |
Marketing Start Date | 1998-01-15 |
Marketing End Date | 2019-11-21 |
Ingredient | Strength |
---|---|
POA PRATENSIS POLLEN | 200 [BAU]/mL |
NDC | Brand Name | Generic Name |
---|---|---|
65044-0845 | Standardized Grass Pollen, Grass Mix 5 | Standardized Grass Pollen, Grass Mix 5 |
65044-0846 | Standardized Grass Pollen, Grass Mix 5 | Standardized Grass Pollen, Grass Mix 5 |
65044-0847 | Standardized Grass Pollen, Grass Mix 5 | Standardized Grass Pollen, Grass Mix 5 |
65044-0848 | Standardized Grass Pollen, Grass Mix 5 | Standardized Grass Pollen, Grass Mix 5 |