ANDA 87634, held by Lederle. Spironolactone.
As of Nov 15, 2026, ANDA 87634 (Spironolactone), held by Lederle, was not approved, with 2 approved supplements and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| Spironolactone25MG ยท tablet;oral | Spironolactone | Discontinued |
| Feb 25, 1985 | Supplement 6Manufacturing | Approved | None posted |
| Aug 4, 1982 | Supplement 1Manufacturing | Approved | None posted |
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
