Application 214410
- Type
- NDA
- Sponsor
- GENENTECH INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | XOFLUZA | BALOXAVIR MARBOXIL | TABLET;ORAL | 20MG | Yes | No |
| 002 | XOFLUZA | BALOXAVIR MARBOXIL | TABLET;ORAL | 40MG | Yes | No |
| 003 | XOFLUZA | BALOXAVIR MARBOXIL | SUSPENSION;ORAL | 40MG/20ML | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82430 | SUPPL | 2026-04-27 |
| 82423 | SUPPL | 2025-06-02 |
| 80683 | SUPPL | 2024-12-23 |
| 80669 | SUPPL | 2024-12-20 |
| 77707 | SUPPL | 2024-03-04 |
| 77693 | SUPPL | 2024-03-04 |
| 74533 | SUPPL | 2023-06-16 |
| 74512 | SUPPL | 2023-06-16 |
| 72204 | ORIG | 2022-10-03 |
| 71793 | ORIG | 2022-08-12 |
| 71780 | ORIG | 2022-08-11 |
| 68794 | SUPPL | 2021-09-28 |
| 66081 | ORIG | 2021-02-03 |
| 65345 | ORIG | 2020-11-25 |
| 65323 | ORIG | 2020-11-25 |