Application 076943
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TORSEMIDE | TORSEMIDE | TABLET;ORAL | 5MG | No | No |
| 002 | TORSEMIDE | TORSEMIDE | TABLET;ORAL | 10MG | No | No |
| 003 | TORSEMIDE | TORSEMIDE | TABLET;ORAL | 20MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0054-0077 | Torsemide | Torsemide | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 43353-315 | Torsemide | Torsemide | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 51407-362 | Torsemide | Torsemide | Golden State Medical Supply | ANDA | Current |
| 70518-2195 | Torsemide | Torsemide | REMEDYREPACK INC. | ANDA | Current |
| 70518-2195 | Torsemide | Torsemide | REMEDYREPACK INC. | ANDA | Current |
| 70518-2195 | Torsemide | Torsemide | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 22597 | ORIG | 2008-07-31 |