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Application 078482
- Type
- ANDA
- Sponsor
- COREPHARMA
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 60505-2651 | Eplerenone | Eplerenone | Apotex Corp | ANDA | Current |
| 60505-2652 | Eplerenone | Eplerenone | Apotex Corp | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9159 | ORIG | 2008-08-05 |