Application 077431
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EXEMESTANE | EXEMESTANE | TABLET;ORAL | 25MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0054-0080 | Exemestane | Exemestane | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0080 | Exemestane | Exemestane | Hikma Pharmaceuticals USA Inc | ANDA | Current |
| 0054-0080 | Exemestane | Exemestane | Hikma Pharmaceuticals USA Inc | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31239 | ORIG | 2011-04-04 |