Application 761173
- Type
- BLA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | STIMUFEND | PEGFILGRASTIM-FPGK | SOLUTION; INJECTION | 6MG/0.6ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65219-371 | STIMUFEND | pegflilgrastim-fpgk | Fresenius Kabi USA, LLC | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83876 | SUPPL | 2025-10-23 |
| 83875 | SUPPL | 2025-10-23 |
| 81768 | SUPPL | 2025-03-28 |
| 81755 | SUPPL | 2025-03-27 |
| 75654 | SUPPL | 2023-10-03 |
| 75635 | SUPPL | 2023-10-02 |
| 72620 | ORIG | 2022-11-16 |
| 72007 | ORIG | 2022-09-02 |
| 72000 | ORIG | 2022-09-02 |