Application 761082
- Type
- BLA
- Sponsor
- KASHIV BIOSCIENCES LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RELEUKO | FILGRASTIM-AYOW | INJECTABLE;INJECTION | 300MCG/ML | No | No |
| 002 | RELEUKO | FILGRASTIM-AYOW | SOLUTION;SUBCUTANEOUS | 480MCG/0.8 ML/VIAL | No | No |
| 003 | RELEUKO | FILGRASTIM-AYOW | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 300MCG/ML | No | No |
| 004 | RELEUKO | FILGRASTIM-AYOW | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 480MCG/1.6ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70121-1568 | RELEUKO | Filgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
| 70121-1568 | RELEUKO | Filgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
| 70121-1568 | RELEUKO | Filgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
| 70121-1568 | RELEUKO | Filgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
| 70121-1568 | RELEUKO | Filgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
| 70121-1568 | RELEUKO | Filgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
| 70121-1569 | RELEUKO | Filgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
| 70121-1569 | RELEUKO | Filgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
| 70121-1569 | RELEUKO | Filgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
| 70121-1569 | RELEUKO | Filgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
| 70121-1569 | RELEUKO | Filgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
| 70121-1569 | RELEUKO | Filgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
| 70121-1570 | RELEUKO | Filgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
| 70121-1570 | RELEUKO | Filgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
| 70121-1570 | RELEUKO | Filgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
| 70121-1570 | RELEUKO | Filgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
| 70121-1570 | RELEUKO | Filgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
| 70121-1570 | RELEUKO | Filgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
| 70121-1571 | RELEUKO | Filgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
| 70121-1571 | RELEUKO | Filgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
| 70121-1571 | RELEUKO | Filgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
| 70121-1571 | RELEUKO | Filgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
| 70121-1571 | RELEUKO | Filgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
| 70121-1571 | RELEUKO | Filgrastim | Amneal Pharmaceuticals LLC | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82138 | SUPPL | 2025-05-05 |
| 82077 | SUPPL | 2025-04-30 |
| 75356 | SUPPL | 2023-09-05 |
| 75352 | SUPPL | 2023-09-05 |
| 72522 | SUPPL | 2022-11-01 |
| 72507 | SUPPL | 2022-10-31 |
| 70736 | ORIG | 2022-04-11 |
| 70709 | ORIG | 2022-04-06 |
| 70293 | ORIG | 2022-02-28 |
| 70283 | ORIG | 2022-02-28 |