Application 079234
- Type
- ANDA
- Sponsor
- HETERO LABS LTD III
Application Products#
Product, Drug, Ingredient table| 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 |
| 004 | TORSEMIDE | TORSEMIDE | TABLET;ORAL | 100MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0615-7997 | Torsemide | Torsemide | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-7997 | Torsemide | Torsemide | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 31722-529 | Torsemide | Torsemide | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-530 | Torsemide | Torsemide | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-531 | Torsemide | Torsemide | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-532 | Torsemide | Torsemide | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 50268-754 | Torsemide | Torsemide | AvPAK | ANDA | Current |
| 50268-754 | Torsemide | Torsemide | AvPAK | ANDA | Current |
| 50268-754 | Torsemide | Torsemide | AvPAK | ANDA | Current |
| 50268-755 | Torsemide | Torsemide | AvPAK | ANDA | Current |
| 50268-755 | Torsemide | Torsemide | AvPAK | ANDA | Current |
| 50268-755 | Torsemide | Torsemide | AvPAK | ANDA | Current |
| 50268-756 | Torsemide | Torsemide | AvPAK | ANDA | Current |
| 50268-756 | Torsemide | Torsemide | AvPAK | ANDA | Current |
| 50268-756 | Torsemide | Torsemide | AvPAK | ANDA | Current |
| 50268-757 | Torsemide | Torsemide | AvPAK | ANDA | Current |
| 50268-757 | Torsemide | Torsemide | AvPAK | ANDA | Current |
| 50268-757 | Torsemide | Torsemide | AvPAK | ANDA | Current |
| 63629-1346 | Torsemide | Torsemide | Bryant Ranch Prepack | ANDA | Current |
| 63629-1346 | Torsemide | Torsemide | Bryant Ranch Prepack | ANDA | Current |
| 63629-4475 | Torsemide | Torsemide | Bryant Ranch Prepack | ANDA | Current |
| 68084-539 | Torsemide | Torsemide | American Health Packaging | ANDA | Current |
| 68084-539 | Torsemide | Torsemide | American Health Packaging | ANDA | Current |
| 68084-539 | Torsemide | Torsemide | American Health Packaging | ANDA | Current |
| 68151-2946 | Torsemide | Torsemide | Carilion Materials Management | ANDA | Current |
| 68151-2948 | Torsemide | Torsemide | Carilion Materials Management | ANDA | Current |
| 68151-2949 | Torsemide | Torsemide | Carilion Materials Management | ANDA | Current |
| 70518-2744 | Torsemide | Torsemide | REMEDYREPACK INC. | ANDA | Current |
| 70518-2744 | Torsemide | Torsemide | REMEDYREPACK INC. | ANDA | Current |
| 70518-2744 | Torsemide | Torsemide | REMEDYREPACK INC. | ANDA | Current |
| 70518-2744 | Torsemide | Torsemide | REMEDYREPACK INC. | ANDA | Current |
| 72189-102 | TORSEMIDE | TORSEMIDE | Direct_Rx | ANDA | Current |
| 72189-102 | TORSEMIDE | TORSEMIDE | Direct_Rx | ANDA | Current |