Application 207842
- Type
- ANDA
- Sponsor
- REGCON SOLUTIONS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EPLERENONE | EPLERENONE | TABLET;ORAL | 25MG | No | No |
| 002 | EPLERENONE | EPLERENONE | TABLET;ORAL | 50MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42291-454 | Eplerenone | Eplerenone | AvKARE | ANDA | Current |
| 42291-454 | Eplerenone | Eplerenone | AvKARE | ANDA | Current |
| 42291-455 | Eplerenone | Eplerenone | AvKARE | ANDA | Current |
| 42291-455 | Eplerenone | Eplerenone | AvKARE | ANDA | Current |
| 69367-307 | Eplerenone | Eplerenone | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-308 | Eplerenone | Eplerenone | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 71205-863 | Eplerenone | Eplerenone | Proficient Rx LP | ANDA | Current |
| 71205-864 | Eplerenone | Eplerenone | Proficient Rx LP | ANDA | Current |