Standardized Redtop Grass Pollen is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Antigen Laboratories, Inc.. The primary component is Agrostis Gigantea Pollen.
| Product ID | 49288-0451_bb0c98b2-aaa8-49c4-887a-928e3937769c |
| NDC | 49288-0451 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Standardized Redtop Grass Pollen |
| Generic Name | Standardized Redtop Grass Pollen |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRADERMAL; SUBCUTANEOUS |
| Marketing Start Date | 1997-06-13 |
| Marketing Category | BLA / BLA |
| Application Number | BLA102229 |
| Labeler Name | Antigen Laboratories, Inc. |
| Substance Name | AGROSTIS GIGANTEA POLLEN |
| Active Ingredient Strength | 100000 [BAU]/mL |
| Pharm Classes | 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 | E |
| Listing Certified Through | 2017-12-31 |
| Marketing Start Date | 1997-06-13 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | BLA |
| Application Number | BLA102229 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1997-06-13 |
| Inactivation Date | 2019-10-21 |
| Marketing Category | BLA |
| Application Number | BLA102229 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1997-06-13 |
| Inactivation Date | 2019-10-21 |
| Marketing Category | BLA |
| Application Number | BLA102229 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1997-06-13 |
| Inactivation Date | 2019-10-21 |
| Marketing Category | BLA |
| Application Number | BLA102229 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1997-06-13 |
| Inactivation Date | 2019-10-21 |
| Ingredient | Strength |
|---|---|
| AGROSTIS GIGANTEA POLLEN | 100000 [BAU]/mL |
| SPL SET ID: | c08f73ff-4f15-449c-9507-c422367f106b |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 36987-2363 | Standardized Redtop Grass Pollen | Standardized Redtop Grass Pollen |
| 36987-2364 | Standardized Redtop Grass Pollen | Standardized Redtop Grass Pollen |
| 49288-0451 | Standardized Redtop Grass Pollen | Standardized Redtop Grass Pollen |
| 54575-099 | STANDARDIZED REDTOP GRASS POLLEN | Agrostis alba pollen |