Application 203794
- Type
- NDA
- Sponsor
- COLLEGIUM PHARM INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NUCYNTA | TAPENTADOL HYDROCHLORIDE | SOLUTION;ORAL | EQ 20MG BASE/ML | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84575 | SUPPL | 2025-12-29 |
| 84524 | SUPPL | 2025-12-23 |
| 80096 | SUPPL | 2024-11-04 |
| 78825 | SUPPL | 2024-06-18 |
| 78824 | SUPPL | 2024-06-18 |
| 78814 | SUPPL | 2024-06-18 |
| 77055 | SUPPL | 2023-12-19 |
| 76955 | SUPPL | 2023-12-18 |
| 76246 | ORIG | 2023-11-03 |
| 74692 | SUPPL | 2023-07-06 |
| 74687 | SUPPL | 2023-07-05 |
| 66649 | SUPPL | 2021-03-08 |
| 66648 | SUPPL | 2021-03-08 |
| 66609 | SUPPL | 2021-03-08 |
| 60427 | SUPPL | 2019-10-09 |
| 60425 | SUPPL | 2019-10-09 |
| 60373 | SUPPL | 2019-10-08 |
| 55724 | SUPPL | 2018-10-01 |
| 55723 | SUPPL | 2018-10-01 |
| 55557 | SUPPL | 2018-09-21 |
| 55556 | SUPPL | 2018-09-21 |
| 55555 | SUPPL | 2018-09-21 |
| 55554 | SUPPL | 2018-09-21 |
| 46430 | SUPPL | 2016-12-21 |
| 46301 | SUPPL | 2016-12-20 |
| 40328 | SUPPL | 2014-11-20 |
| 19493 | SUPPL | 2014-11-20 |
| 32468 | SUPPL | 2014-11-19 |
| 10251 | SUPPL | 2014-11-19 |
| 43444 | ORIG | 2012-11-16 |
| 24450 | ORIG | 2012-11-16 |
| 32467 | ORIG | 2012-10-18 |
| 43968 | ORIG | 2012-10-17 |
| 19492 | ORIG | 2012-10-17 |