Application 021961
- Type
- NDA
- Sponsor
- SYNTHON PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SIMVASTATIN | SIMVASTATIN | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | No | No |
| 002 | SIMVASTATIN | SIMVASTATIN | TABLET, ORALLY DISINTEGRATING;ORAL | 20MG | No | No |
| 003 | SIMVASTATIN | SIMVASTATIN | TABLET, ORALLY DISINTEGRATING;ORAL | 40MG | No | No |
| 004 | SIMVASTATIN | SIMVASTATIN | TABLET, ORALLY DISINTEGRATING;ORAL | 80MG | No | No |