Application 204972
- Type
- ANDA
- Sponsor
- ACTAVIS ELIZABETH
Related Records
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 | Title | Submission type | Submission no. | Date | Storage |
|---|---|---|---|---|---|
| 48652 | 0 | ORIG | 1 | 2017-06-06 | Cached in FDA.report object storage |