MIXED MOLDS is a Subcutaneous Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Alternaria Alternata; Cladosporium Sphaerospermum; Aspergillus Niger Var. Niger; Aspergillus Repens; Aspergillus Flavus Var. Oryzae; Aspergillus Terreus; Penicillium Chrysogenum Var. Chrysogenum.
| Product ID | 0268-8050_31222992-de8e-4717-ac14-f2214d9ef672 |
| NDC | 0268-8050 |
| Product Type | Non-standardized Allergenic |
| Proprietary Name | MIXED MOLDS |
| Generic Name | Alternaria Alternata, Cladosporium Sphaerospermum, Aspergillus Niger, Aspergillus Repens, Aspergillus Oryzae, Aspergillus Terreus, Penicillium Chrysogenum, Penicillium Notatum |
| 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 | ALTERNARIA ALTERNATA; CLADOSPORIUM SPHAEROSPERMUM; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; ASPERGILLUS FLAVUS VAR. ORYZAE; ASPERGILLUS TERREUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM |
| 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],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] |
| 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 |
|---|---|
| ALTERNARIA ALTERNATA | 20000 [PNU]/mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0268-8045 | MIXED MOLDS | ALTERNARIA ALTERNATA, ASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS, CLADOSPORIUM SPHAEROSPERMUM and PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM |
| 0268-8046 | MIXED MOLDS | ALTERNARIA ALTERNATA, ASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS, CLADOSPORIUM SPHAEROSPERMUM, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM |
| 0268-8047 | MIXED MOLDS | ALTERNARIA ALTERNATA, ASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS, CLADOSPORIUM SPHAEROSPERMUM, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM |
| 0268-8048 | MIXED MOLDS | ALTERNARIA ALTERNATA, ASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS, CLADOSPORIUM SPHAEROSPERMUM, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM |
| 0268-8049 | MIXED MOLDS | ALTERNARIA ALTERNATA, CLADOSPORIUM SPHAEROSPERMUM, ASPERGILLUS NIGER, ASPERGILLUS REPENS, ASPERGILLUS ORYZAE, ASPERGILLUS TERREUS, PENICILLIUM CHRYSOGENUM, PENICILLIUM NOTATUM |
| 0268-8050 | MIXED MOLDS | ALTERNARIA ALTERNATA, CLADOSPORIUM SPHAEROSPERMUM, ASPERGILLUS NIGER, ASPERGILLUS REPENS, ASPERGILLUS ORYZAE, ASPERGILLUS TERREUS, PENICILLIUM CHRYSOGENUM, PENICILLIUM NOTATUM |