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Application 217369
- Type
- NDA
- Sponsor
- BIOGEN INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZURZUVAE | ZURANOLONE | CAPSULE;ORAL | 20MG | Yes | No |
| 002 | ZURZUVAE | ZURANOLONE | CAPSULE;ORAL | 25MG | Yes | No |
| 003 | ZURZUVAE | ZURANOLONE | CAPSULE;ORAL | 30MG | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85739 | SUPPL | 2026-04-24 |
| 85730 | SUPPL | 2026-04-21 |
| 79286 | SUPPL | 2024-08-02 |
| 79285 | SUPPL | 2024-08-02 |
| 79276 | SUPPL | 2024-08-02 |
| 76645 | ORIG | 2023-10-31 |
| 75323 | ORIG | 2023-08-31 |
| 75010 | ORIG | 2023-08-08 |
| 75012 | ORIG | 2023-08-07 |