Application 218255
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | TABLET, EXTENDED RELEASE;ORAL | 30MG | No | No |
| 002 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | TABLET, EXTENDED RELEASE;ORAL | 60MG | No | No |
| 003 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | TABLET, EXTENDED RELEASE;ORAL | 120MG | No | No |