Birch Mixture 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 Lenta Pollen; Betula Papyrifera Pollen; Betula Nigra Pollen; Betula Occidentalis Pollen; Betula Populifolia Pollen; Betula Alleghaniensis Pollen.
| Product ID | 49288-0057_13c9eea1-38b5-472b-b735-a814ca886718 |
| NDC | 49288-0057 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Birch Mixture |
| Generic Name | Birch Mixture |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRADERMAL; SUBCUTANEOUS |
| Marketing Start Date | 1974-03-23 |
| Marketing Category | BLA / BLA |
| Application Number | BLA102223 |
| Labeler Name | Antigen Laboratories, Inc. |
| Substance Name | BETULA LENTA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS POLLEN; BETULA POPULIFOLIA POLLEN; BETULA ALLEGHANIENSIS POLLEN |
| Active Ingredient Strength | 0 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL |
| Pharm Classes | Increased Histamine Release [PE],Cell-mediated Immunity [PE],Non-Standardized Pollen Allergenic Extract [EPC],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],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-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] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
| Marketing Start Date | 1974-03-23 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | BLA |
| Application Number | BLA102223 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1974-03-23 |
| Inactivation Date | 2019-10-21 |
| Marketing Category | BLA |
| Application Number | BLA102223 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1974-03-23 |
| Inactivation Date | 2019-10-21 |
| Marketing Category | BLA |
| Application Number | BLA102223 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1974-03-23 |
| Inactivation Date | 2019-10-21 |
| Marketing Category | BLA |
| Application Number | BLA102223 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1974-03-23 |
| Inactivation Date | 2019-10-21 |
| Marketing Category | BLA |
| Application Number | BLA102223 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1974-03-23 |
| Inactivation Date | 2019-10-21 |
| Ingredient | Strength |
|---|---|
| BETULA LENTA POLLEN | .0033 g/mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 49288-0056 | Birch Mixture | Birch Mixture |
| 49288-0057 | Birch Mixture | Birch Mixture |