Application 217188
- Type
- NDA
- Sponsor
- PFIZER
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PAXLOVID (COPACKAGED) | NIRMATRELVIR; RITONAVIR | TABLET;ORAL | 150MG;100MG | Yes | Yes |
| 002 | PAXLOVID (COPACKAGED) | NIRMATRELVIR; RITONAVIR | TABLET;ORAL | 300MG;100MG | Yes | Yes |
Documents
| Document | Submission type | Date |
|---|---|---|
| 85066 | SUPPL | 2026-02-18 |
| 85065 | SUPPL | 2026-02-18 |
| 85037 | SUPPL | 2026-02-12 |
| 85036 | SUPPL | 2026-02-12 |
| 81251 | SUPPL | 2025-02-14 |
| 81239 | SUPPL | 2025-02-13 |
| 81101 | SUPPL | 2025-02-06 |
| 80968 | SUPPL | 2025-02-05 |
| 80258 | SUPPL | 2024-11-21 |
| 80253 | SUPPL | 2024-11-20 |
| 79619 | SUPPL | 2024-09-16 |
| 79585 | SUPPL | 2024-09-16 |
| 74614 | ORIG | 2023-06-23 |
| 74367 | ORIG | 2023-05-25 |
| 74366 | ORIG | 2023-05-25 |