Application 086221
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | TABLET;ORAL | 5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-1635 | Isosorbide Dinitrate | Isosorbide Dinitrate | Sandoz Inc. | ANDA | Current |
| 0781-1635 | Isosorbide Dinitrate | Isosorbide Dinitrate | Sandoz Inc. | ANDA | Current |
| 0781-1635 | Isosorbide Dinitrate | Isosorbide Dinitrate | Sandoz Inc. | ANDA | Current |
| 0781-1635 | Isosorbide Dinitrate | Isosorbide Dinitrate | Sandoz Inc. | ANDA | Current |
| 0781-1635 | Isosorbide Dinitrate | Isosorbide Dinitrate | Sandoz Inc | ANDA | Current |
| 68001-223 | Isosorbide Dinitrate | Isosorbide Dinitrate | BluePoint Laboratories | ANDA | Current |
| 68001-223 | Isosorbide Dinitrate | Isosorbide Dinitrate | BluePoint Laboratories | ANDA | Current |
| 68084-894 | Isosorbide Dinitrate | Isosorbide Dinitrate | American Health Packaging | ANDA | Current |