Red (River) Birch 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 Betula Nigra Pollen.
| Product ID | 49288-0077_13c9eea1-38b5-472b-b735-a814ca886718 |
| NDC | 49288-0077 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Red (River) Birch |
| Generic Name | Red (river) Birch |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRADERMAL; SUBCUTANEOUS |
| Marketing Start Date | 1992-04-13 |
| Marketing Category | BLA / BLA |
| Application Number | BLA102223 |
| Labeler Name | Antigen Laboratories, Inc. |
| Substance Name | BETULA NIGRA POLLEN |
| Active Ingredient Strength | 0 g/mL |
| Pharm Classes | 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 | 1992-04-13 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | BLA |
| Application Number | BLA102223 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1992-04-13 |
| Inactivation Date | 2019-10-21 |
| Marketing Category | BLA |
| Application Number | BLA102223 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1992-04-13 |
| Inactivation Date | 2019-10-21 |
| Marketing Category | BLA |
| Application Number | BLA102223 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1992-04-13 |
| Inactivation Date | 2019-10-21 |
| Marketing Category | BLA |
| Application Number | BLA102223 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1992-04-13 |
| Inactivation Date | 2019-10-21 |
| Marketing Category | BLA |
| Application Number | BLA102223 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1992-04-13 |
| Inactivation Date | 2019-10-21 |
| Ingredient | Strength |
|---|---|
| BETULA NIGRA POLLEN | .1 g/mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 49288-0077 | Red (River) Birch | Red (River) Birch |
| 49288-0078 | Red (River) Birch | Red (River) Birch |