Skip to contentApplication 761045
- Type
- BLA
- Sponsor
- SANDOZ INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZIEXTENZO | PEGFILGRASTIM-BMEZ | INJECTABLE;INJECTION | 6MG/0.6ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 61314-866 | ZIEXTENZO | pegfilgrastim-bmez | Sandoz Inc | BLA | Current |
| 61314-866 | ZIEXTENZO | pegfilgrastim-bmez | Sandoz Inc | BLA | Current |
| 61314-866 | ZIEXTENZO | pegfilgrastim-bmez | Sandoz Inc | BLA | Current |
| 61314-866 | ZIEXTENZO | pegfilgrastim-bmez | Sandoz Inc | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85941 | SUPPL | 2026-05-18 |
| 85905 | SUPPL | 2026-05-13 |
| 77652 | SUPPL | 2024-02-29 |
| 77651 | SUPPL | 2024-02-29 |
| 75700 | SUPPL | 2023-10-10 |
| 75682 | SUPPL | 2023-10-10 |
| 66788 | SUPPL | 2021-03-16 |
| 66780 | SUPPL | 2021-03-15 |
| 61459 | ORIG | 2019-12-27 |
| 60789 | ORIG | 2019-12-26 |
| 60781 | ORIG | 2019-11-05 |