Skip to contentApplication 214876
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZEJULA | NIRAPARIB TOSYLATE | TABLET;ORAL | EQ 100MG BASE | Yes | No |
| 002 | ZEJULA | NIRAPARIB TOSYLATE | TABLET;ORAL | EQ 200MG BASE | Yes | No |
| 003 | ZEJULA | NIRAPARIB TOSYLATE | TABLET;ORAL | EQ 300MG BASE | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85603 | SUPPL | 2026-03-31 |
| 85602 | SUPPL | 2026-03-31 |
| 83093 | SUPPL | 2025-08-12 |
| 82890 | SUPPL | 2025-07-21 |
| 82889 | SUPPL | 2025-07-21 |
| 82621 | SUPPL | 2025-06-20 |
| 82620 | SUPPL | 2025-06-20 |
| 82612 | SUPPL | 2025-06-20 |
| 82611 | SUPPL | 2025-06-20 |
| 76589 | ORIG | 2023-11-16 |
| 74100 | ORIG | 2023-04-27 |
| 74093 | ORIG | 2023-04-27 |