Pollens - Grasses, Southern Grass Mix is a Percutaneous; Subcutaneous Injection, Solution in the Non-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; Sorghum Halepense Pollen; Cynodon Dactylon Pollen.
| Product ID | 65044-0854_542aadd7-a419-42a2-a51d-25c08491a652 |
| NDC | 65044-0854 |
| Product Type | Non-standardized Allergenic |
| Proprietary Name | Pollens - Grasses, Southern Grass Mix |
| Generic Name | Pollens - Grasses, Southern Grass Mix |
| Dosage Form | Injection, Solution |
| Route of Administration | PERCUTANEOUS; SUBCUTANEOUS |
| Marketing Start Date | 1941-04-19 |
| Marketing Category | BLA / BLA |
| Application Number | BLA103888 |
| Labeler Name | Jubilant HollisterStier LLC |
| Substance Name | POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN; SORGHUM HALEPENSE POLLEN; CYNODON DACTYLON POLLEN |
| Active Ingredient Strength | 100000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/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],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 1941-04-19 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | BLA |
| Application Number | BLA103888 |
| Product Type | NON-STANDARDIZED ALLERGENIC |
| Marketing Start Date | 1941-04-19 |
| Marketing Category | BLA |
| Application Number | BLA103888 |
| Product Type | NON-STANDARDIZED ALLERGENIC |
| Marketing Start Date | 1941-04-19 |
| Marketing Category | BLA |
| Application Number | BLA103888 |
| Product Type | NON-STANDARDIZED ALLERGENIC |
| Marketing Start Date | 1941-04-19 |
| Ingredient | Strength |
|---|---|
| POA PRATENSIS POLLEN | 100000 [BAU]/mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 65044-0854 | Pollens - Grasses, Southern Grass Mix | Pollens - Grasses, Southern Grass Mix |
| 65044-0855 | Pollens - Grasses, Southern Grass Mix | Pollens - Grasses, Southern Grass Mix |
| 65044-0856 | Pollens - Grasses, Southern Grass Mix | Pollens - Grasses, Southern Grass Mix |
| 65044-0857 | Pollens - Grasses, Southern Grass Mix | Pollens - Grasses, Southern Grass Mix |