Application 020438
- Type
- NDA
- Sponsor
- CHEPLAPHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VESANOID | TRETINOIN | CAPSULE;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79832 | SUPPL | 2024-10-07 |
| 79825 | SUPPL | 2024-10-07 |
| 73589 | SUPPL | 2023-02-22 |
| 73588 | SUPPL | 2023-02-22 |
| 73585 | SUPPL | 2023-02-22 |
| 73584 | SUPPL | 2023-02-22 |
| 12578 | SUPPL | 2015-09-14 |
| 24964 | SUPPL | 2008-07-08 |
| 34649 | SUPPL | 2004-10-08 |
| 24963 | SUPPL | 2004-10-08 |
| 41358 | SUPPL | 2004-04-14 |
| 34648 | SUPPL | 2000-02-14 |
| 24962 | SUPPL | 2000-02-14 |