ANDA 212765, held by Pharmazone. Eplerenone.
As of Nov 15, 2026, ANDA 212765 (Eplerenone), held by Pharmazone, was first approved by FDA on Aug 10, 2020, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 10, 2020 | Original application | Approved | None posted |
| Eplerenone25MG · tablet;oral | Eplerenone | Rx |
| Eplerenone50MG · tablet;oral | Eplerenone | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
