MIXED ASPERGILLUS is a Subcutaneous Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Aspergillus Niger Var. Niger; Aspergillus Repens; Aspergillus Flavus Var. Oryzae; Aspergillus Terreus.
| Product ID | 0268-8037_31222992-de8e-4717-ac14-f2214d9ef672 |
| NDC | 0268-8037 |
| Product Type | Non-standardized Allergenic |
| Proprietary Name | MIXED ASPERGILLUS |
| Generic Name | Aspergillus Niger, Aspergillus Repens, Aspergillus Oryzae, Aspergillus Terreus |
| Dosage Form | Injection, Solution |
| Route of Administration | SUBCUTANEOUS |
| Marketing Start Date | 1998-02-23 |
| Marketing Category | BLA / BLA |
| Application Number | BLA103753 |
| Labeler Name | ALK-Abello, Inc. |
| Substance Name | ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; ASPERGILLUS FLAVUS VAR. ORYZAE; ASPERGILLUS TERREUS |
| Active Ingredient Strength | 10000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL |
| Pharm Classes | Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 1998-02-23 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | BLA |
| Application Number | BLA103753 |
| Product Type | NON-STANDARDIZED ALLERGENIC |
| Marketing Start Date | 1998-02-23 |
| Ingredient | Strength |
|---|---|
| ASPERGILLUS NIGER VAR. NIGER | 10000 [PNU]/mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0268-0970 | MIXED ASPERGILLUS | MIXED ASPERGILLUS |
| 0268-6559 | MIXED ASPERGILLUS | MIXED ASPERGILLUS |
| 0268-8034 | MIXED ASPERGILLUS | ASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS |
| 0268-8035 | MIXED ASPERGILLUS | ASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS |
| 0268-8036 | MIXED ASPERGILLUS | ASPERGILLUS NIGER, ASPERGILLUS REPENS, ASPERGILLUS ORYZAE, ASPERGILLUS TERREUS |
| 0268-8037 | MIXED ASPERGILLUS | ASPERGILLUS NIGER, ASPERGILLUS REPENS, ASPERGILLUS ORYZAE, ASPERGILLUS TERREUS |