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Application 218637
- Type
- NDA
- Sponsor
- KAMAT
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RALDESY | TRAZODONE HYDROCHLORIDE | SOLUTION;ORAL | 10MG/ML | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84216 | SUPPL | 2025-11-19 |
| 84215 | SUPPL | 2025-11-19 |
| 84214 | SUPPL | 2025-11-19 |
| 83778 | SUPPL | 2025-10-15 |
| 83777 | SUPPL | 2025-10-15 |
| 83024 | ORIG | 2025-08-01 |
| 82659 | SUPPL | 2025-06-25 |
| 80463 | ORIG | 2024-12-02 |
| 80438 | ORIG | 2024-11-29 |