GRASS MIX 4-S is a Percutaneous Injection, Solution in the Standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Phleum Pratense Pollen; Poa Pratensis Pollen; Agrostis Gigantea Pollen; Dactylis Glomerata Pollen.
| Product ID | 0268-8026_47e6c112-d8d7-484e-adb7-db0dd7627abc |
| NDC | 0268-8026 |
| Product Type | Standardized Allergenic |
| Proprietary Name | GRASS MIX 4-S |
| Generic Name | Agrostis Gigantea Pollen, Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Festuca Pratensis Pollen, Lolium Perenne Pollen, Phleum Pratense Pollen And Poa Pratensis Pollen |
| Dosage Form | Injection, Solution |
| Route of Administration | PERCUTANEOUS |
| Marketing Start Date | 1997-12-18 |
| Marketing Category | BLA / BLA |
| Application Number | BLA103058 |
| Labeler Name | ALK-Abello, Inc. |
| Substance Name | PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; DACTYLIS GLOMERATA POLLEN |
| Active Ingredient Strength | 25000 [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] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 1997-12-18 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | BLA |
| Application Number | BLA103058 |
| Product Type | STANDARDIZED ALLERGENIC |
| Marketing Start Date | 1997-12-18 |
| Ingredient | Strength |
|---|---|
| PHLEUM PRATENSE POLLEN | 25000 [BAU]/mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0268-8026 | GRASS MIX 4-S | AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, FESTUCA PRATENSIS POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN and POA PRATENSIS POLLEN |
| 0268-8076 | MIX OF 7 STANDARD GRASS POLLEN | AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, FESTUCA PRATENSIS POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN and POA PRATENSIS POLLEN |