Application 218381
- Type
- ANDA
- Sponsor
- APOTEX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TOLVAPTAN | TOLVAPTAN | TABLET;ORAL | 15MG | No | No |
| 002 | TOLVAPTAN | TOLVAPTAN | TABLET;ORAL | 30MG | No | No |
| 003 | TOLVAPTAN | TOLVAPTAN | TABLET;ORAL | 45MG | No | No |
| 004 | TOLVAPTAN | TOLVAPTAN | TABLET;ORAL | 60MG | No | No |
| 005 | TOLVAPTAN | TOLVAPTAN | TABLET;ORAL | 90MG | No | No |