Application 079196
- Type
- ANDA
- Sponsor
- WEST-WARD PHARMS INT
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BUMETANIDE | BUMETANIDE | INJECTABLE;INJECTION | 0.25MG/ML | No | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0641-6007 | Bumetanide | Bumetanide | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-6007 | Bumetanide | Bumetanide | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6008 | Bumetanide | Bumetanide | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-6008 | Bumetanide | Bumetanide | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6161 | Bumetanide | Bumetanide | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-6161 | Bumetanide | Bumetanide | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6162 | Bumetanide | Bumetanide | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-6162 | Bumetanide | Bumetanide | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 51662-1449 | BUMETANIDE | BUMETANIDE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1449 | BUMETANIDE | BUMETANIDE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 72572-040 | Bumetanide | Bumetanide | Civica, Inc. | ANDA | Current |
| 72572-040 | Bumetanide | Bumetanide | Civica, Inc. | ANDA | Current |
| 72572-041 | Bumetanide | Bumetanide | Civica, Inc. | ANDA | Current |
| 72572-041 | Bumetanide | Bumetanide | Civica, Inc. | ANDA | Current |