Application 216557
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA
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 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59651-539 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-540 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-541 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | Aurobindo Pharma Limited | ANDA | Current |