Application 209916
- Type
- ANDA
- Sponsor
- UPSHER SMITH LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUMETANIDE | BUMETANIDE | TABLET;ORAL | 0.5MG | No | No |
| 002 | BUMETANIDE | BUMETANIDE | TABLET;ORAL | 1MG | No | No |
| 003 | BUMETANIDE | BUMETANIDE | TABLET;ORAL | 2MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0832-0540 | Bumetanide | BUMETANIDE | Upsher-Smith Laboratories, LLC | ANDA | Current |
| 0832-0541 | Bumetanide | BUMETANIDE | Upsher-Smith Laboratories, LLC | ANDA | Current |
| 0832-0542 | Bumetanide | BUMETANIDE | Upsher-Smith Laboratories, LLC | ANDA | Current |