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Application 217026
- Type
- NDA
- Sponsor
- ACADIA PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DAYBUE | TROFINETIDE | SOLUTION;ORAL | 200MG/ML | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85605 | SUPPL | 2026-03-31 |
| 85573 | SUPPL | 2026-03-30 |
| 83130 | SUPPL | 2025-08-19 |
| 83129 | SUPPL | 2025-08-19 |
| 83056 | SUPPL | 2025-08-06 |
| 83055 | SUPPL | 2025-08-06 |
| 79798 | SUPPL | 2024-10-03 |
| 79799 | SUPPL | 2024-10-02 |
| 79787 | SUPPL | 2024-10-01 |
| 79786 | SUPPL | 2024-10-01 |
| 73952 | ORIG | 2023-04-06 |
| 73740 | ORIG | 2023-03-30 |
| 73738 | ORIG | 2023-03-13 |