Application 210822
- Type
- ANDA
- Sponsor
- DEXCEL LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | TABLET, EXTENDED RELEASE;ORAL | 120MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 23155-628 | Isosorbide Mononitrate | Isosorbide Mononitrate | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-628 | Isosorbide Mononitrate | isosorbide mononitrate | Heritage Pharmaceuticals, Inc. | ANDA | Current |
| 23155-628 | Isosorbide Mononitrate | Isosorbide Mononitrate | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |