FAPP MIXTURE is a Subcutaneous Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Gibberella Zeae; Aspergillus Niger Var. Niger; Aspergillus Repens; Aspergillus Flavus Var. Oryzae; Aspergillus Terreus; Penicillium Chrysogenum Var. Chrysogenum; Phoma Exigua Var. Exigua.
| Product ID | 0268-8025_25c99df0-1f9c-45e1-950b-88e8cb11ed1d |
| NDC | 0268-8025 |
| Product Type | Non-standardized Allergenic |
| Proprietary Name | FAPP MIXTURE |
| Generic Name | Aspergillus Flavus Var. Oryzae, Aspergillus Niger Var. Niger, Aspergillus Repens, Aspergillus Terreus, Gibberella Zeae, Penicillium Chrysogenum Var. Chrysogenum, Phoma Exigua Var. Exigua |
| Dosage Form | Injection, Solution |
| Route of Administration | SUBCUTANEOUS |
| Marketing Start Date | 1965-01-01 |
| Marketing Category | BLA / BLA |
| Application Number | BLA103753 |
| Labeler Name | ALK-Abello, Inc. |
| Substance Name | GIBBERELLA ZEAE; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; ASPERGILLUS FLAVUS VAR. ORYZAE; ASPERGILLUS TERREUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA EXIGUA VAR. EXIGUA |
| Active Ingredient Strength | 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [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],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],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 1965-01-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | BLA |
| Application Number | BLA103753 |
| Product Type | NON-STANDARDIZED ALLERGENIC |
| Marketing Start Date | 1965-01-01 |
| Ingredient | Strength |
|---|---|
| GIBBERELLA ZEAE | 20000 [PNU]/mL |