9 TREE MIX is a Subcutaneous Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Alnus Rhombifolia Pollen; Fraxinus Americana Pollen; Ulmus Crassifolia Pollen; Betula Lenta Pollen; Acer Saccharum Pollen; Carya Ovata Pollen; Quercus Alba Pollen; Populus Alba Pollen; Platanus Occidentalis Pollen.
| Product ID | 0268-8023_f3eb7e34-520b-49b3-a60f-3cd9cc08ae0d |
| NDC | 0268-8023 |
| Product Type | Non-standardized Allergenic |
| Proprietary Name | 9 TREE MIX |
| Generic Name | Acer Saccharum Pollen, Alnus Rhombifolia Pollen, Betula Lenta Pollen, Carya Ovata Pollen, Fraxinus Americana Pollen, Platanus Occidentalis Pollen, Populus Alba Pollen, Quercus Alba Pollen, Ulmus Crassifolia Pollen |
| Dosage Form | Injection, Solution |
| Route of Administration | SUBCUTANEOUS |
| Marketing Start Date | 1975-01-15 |
| Marketing Category | BLA / BLA |
| Application Number | BLA103753 |
| Labeler Name | ALK-Abello, Inc. |
| Substance Name | ALNUS RHOMBIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; BETULA LENTA POLLEN; ACER SACCHARUM POLLEN; CARYA OVATA POLLEN; QUERCUS ALBA POLLEN; POPULUS ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN |
| Active Ingredient Strength | 10000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/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],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],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],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],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 | 2019-12-31 |
| Marketing Start Date | 1975-01-15 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | BLA |
| Application Number | BLA103753 |
| Product Type | NON-STANDARDIZED ALLERGENIC |
| Marketing Start Date | 2020-01-23 |
| Marketing Category | BLA |
| Application Number | BLA103753 |
| Product Type | NON-STANDARDIZED ALLERGENIC |
| Marketing Start Date | 1975-01-15 |
| Ingredient | Strength |
|---|---|
| ALNUS RHOMBIFOLIA POLLEN | 10000 [PNU]/mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0268-8019 | 9 TREE MIX | ACER SACCHARUM POLLEN, ALNUS RHOMBIFOLIA POLLEN, BETULA LENTA POLLEN, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS ALBA POLLEN, QUERCUS ALBA POLLEN and ULMUS CRASSIFOLIA POLLEN |
| 0268-8020 | 9 TREE MIX | ACER SACCHARINUM POLLEN, ALNUS RHOMBIFOLIA POLLEN, BETULA LENTA WHOLE, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS ALBA POLLEN, QUERCUS ALBA POLLEN, ULMUS AMERICANA POLLEN |
| 0268-8021 | 9 TREE MIX | ACER SACCHARINUM POLLEN, ALNUS RHOMBIFOLIA POLLEN, BETULA LENTA WHOLE, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS ALBA POLLEN, QUERCUS ALBA POLLEN, ULMUS CRASSIFOLIA POLLEN |
| 0268-8022 | 9 TREE MIX | ACER SACCHARUM POLLEN, ALNUS RHOMBIFOLIA POLLEN, BETULA LENTA POLLEN, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS ALBA POLLEN, QUERCUS ALBA POLLEN and ULMUS CRASSIFOLIA POLLEN |
| 0268-8023 | 9 TREE MIX | ACER SACCHARUM POLLEN, ALNUS RHOMBIFOLIA POLLEN, BETULA LENTA POLLEN, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS ALBA POLLEN, QUERCUS ALBA POLLEN, ULMUS CRASSIFOLIA POLLEN |