MIDWEST MIX OF STANDARD GRASS is a Subcutaneous Injection, Solution in the Standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Phleum Pratense Pollen; Dactylis Glomerata Pollen; Poa Pratensis Pollen; Agrostis Gigantea Pollen.
| Product ID | 0268-8077_0d292dae-220a-45c7-94cb-cade20038419 |
| NDC | 0268-8077 |
| Product Type | Standardized Allergenic |
| Proprietary Name | MIDWEST MIX OF STANDARD GRASS |
| Generic Name | Agrostis Gigantea Pollen, Dactylis Glomerata Pollen, Phleum Pratense Pollen And Poa Pratensis Pollen |
| Dosage Form | Injection, Solution |
| Route of Administration | SUBCUTANEOUS |
| Marketing Start Date | 1997-12-18 |
| Marketing Category | BLA / BLA |
| Application Number | BLA103058 |
| Labeler Name | ALK-Abello, Inc. |
| Substance Name | PHLEUM PRATENSE POLLEN; DACTYLIS GLOMERATA POLLEN; POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN |
| Active Ingredient Strength | 40000 [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],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] |
| 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 | 40000 [BAU]/mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0268-8077 | MIDWEST MIX OF STANDARD GRASS | AGROSTIS GIGANTEA POLLEN, DACTYLIS GLOMERATA POLLEN, PHLEUM PRATENSE POLLEN and POA PRATENSIS POLLEN |
| 0268-8026 | GRASS MIX Number 4-S | AGROSTIS GIGANTEA POLLEN, DACTYLIS GLOMERATA POLLEN, PHLEUM PRATENSE POLLEN and POA PRATENSIS POLLEN |
| 0268-8027 | GRASS MIX Number 4-S | AGROSTIS GIGANTEA POLLEN, DACTYLIS GLOMERATA POLLEN, PHLEUM PRATENSE POLLEN and POA PRATENSIS POLLEN |