ANDA 87108, held by Ivax Pharms. Spironolactone.
As of Nov 15, 2026, ANDA 87108 (Spironolactone), held by Ivax Pharms, was first approved by FDA on May 7, 1980, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 7, 1980 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Spironolactone25MG ยท tablet;oral | Spironolactone | Discontinued |
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
