Molds, Rusts and Smuts, Aspergillus niger is a Percutaneous; Subcutaneous Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Jubilant Hollisterstier Llc. The primary component is Aspergillus Niger Var. Niger.
| Product ID | 65044-5032_542aadd7-a419-42a2-a51d-25c08491a652 |
| NDC | 65044-5032 |
| Product Type | Non-standardized Allergenic |
| Proprietary Name | Molds, Rusts and Smuts, Aspergillus niger |
| Generic Name | Aspergillus Niger |
| Dosage Form | Injection, Solution |
| Route of Administration | PERCUTANEOUS; SUBCUTANEOUS |
| Marketing Start Date | 1941-04-19 |
| Marketing Category | BLA / BLA |
| Application Number | BLA103888 |
| Labeler Name | Jubilant HollisterStier LLC |
| Substance Name | ASPERGILLUS NIGER VAR. NIGER |
| Active Ingredient Strength | 0 g/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] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 1941-04-19 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | BLA |
| Application Number | BLA103888 |
| Product Type | NON-STANDARDIZED ALLERGENIC |
| Marketing Start Date | 1941-04-19 |
| Marketing Category | BLA |
| Application Number | BLA103888 |
| Product Type | NON-STANDARDIZED ALLERGENIC |
| Marketing Start Date | 1941-04-19 |
| Marketing Category | BLA |
| Application Number | BLA103888 |
| Product Type | NON-STANDARDIZED ALLERGENIC |
| Marketing Start Date | 1941-04-19 |
| Ingredient | Strength |
|---|---|
| ASPERGILLUS NIGER VAR. NIGER | .1 g/mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 65044-5032 | Molds, Rusts and Smuts, Aspergillus niger | Molds, Rusts and Smuts, Aspergillus niger |
| 65044-5033 | Molds, Rusts and Smuts, Aspergillus niger | Molds, Rusts and Smuts, Aspergillus niger |
| 22840-1625 | Aspergillus niger | Aspergillus niger |
| 22840-1626 | Aspergillus niger | Aspergillus niger |
| 22840-1627 | Aspergillus niger | Aspergillus niger |
| 22840-1628 | Aspergillus niger | Aspergillus niger |
| 22840-5606 | Aspergillus niger | Aspergillus niger |
| 0268-0827 | ASPERGILLUS NIGER VAR NIGER | ASPERGILLUS NIGER |
| 0268-0828 | ASPERGILLUS NIGER VAR NIGER | ASPERGILLUS NIGER |
| 0268-0829 | ASPERGILLUS NIGER VAR NIGER | ASPERGILLUS NIGER |
| 0268-0830 | ASPERGILLUS NIGER VAR NIGER | ASPERGILLUS NIGER |
| 0268-6507 | ASPERGILLUS NIGER VAR NIGER | Aspergillus Niger |
| 0268-6508 | ASPERGILLUS NIGER VAR NIGER | Aspergillus Niger |