Application 204972
- Type
- ANDA
- Sponsor
- ACTAVIS ELIZABETH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TAPENTADOL | TAPENTADOL | TABLET, EXTENDED RELEASE;ORAL | 50MG | No | No |
| 002 | TAPENTADOL | TAPENTADOL | TABLET, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 003 | TAPENTADOL | TAPENTADOL | TABLET, EXTENDED RELEASE;ORAL | 150MG | No | No |
| 004 | TAPENTADOL | TAPENTADOL | TABLET, EXTENDED RELEASE;ORAL | 200MG | No | No |
| 005 | TAPENTADOL | TAPENTADOL | TABLET, EXTENDED RELEASE;ORAL | 250MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 48652 | ORIG | 2017-06-06 |