Application 214755
- Type
- NDA
- Sponsor
- AVADEL CNS PHARMA LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LUMRYZ | SODIUM OXYBATE | SUSPENSION;ORAL | 4.5G | No | No |
| 002 | LUMRYZ | SODIUM OXYBATE | SUSPENSION;ORAL | 6G | No | No |
| 003 | LUMRYZ | SODIUM OXYBATE | SUSPENSION;ORAL | 7.5G | No | No |
| 004 | LUMRYZ | SODIUM OXYBATE | SUSPENSION;ORAL | 9G | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84209 | SUPPL | 2025-11-19 |
| 81540 | SUPPL | 2025-03-12 |
| 80657 | SUPPL | 2024-12-20 |
| 80488 | SUPPL | 2024-12-04 |
| 79944 | SUPPL | 2024-10-21 |
| 79943 | SUPPL | 2024-10-21 |
| 79910 | SUPPL | 2024-10-17 |
| 79756 | SUPPL | 2024-09-27 |
| 79751 | SUPPL | 2024-09-26 |
| 77203 | SUPPL | 2024-01-11 |
| 74154 | ORIG | 2023-11-07 |
| 76031 | SUPPL | 2023-11-02 |
| 76005 | ORIG | 2023-10-31 |
| 74150 | ORIG | 2023-05-02 |
| 71622 | ORIG | 2022-07-25 |