ANDA 87265, held by Mutual Pharm. Spironolactone.
As of Nov 15, 2026, ANDA 87265 (Spironolactone), held by Mutual Pharm, was first approved by FDA on Jan 28, 1981, with 17 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 28, 1981 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Spironolactone25MG ยท tablet;oral | Spironolactone | Discontinued |
| Apr 22, 1999 | Supplement 29Labeling | Approved | None posted |
| Dec 1, 1998 | Supplement 28Manufacturing | Approved | None posted |
| Dec 23, 1994 | Supplement 27Manufacturing | Approved | None posted |
| Oct 11, 1994 | Supplement 26Manufacturing | Approved | None posted |
| Jun 9, 1993 | Supplement 25Labeling | Approved | None posted |
| Apr 3, 1992 | Supplement 22Manufacturing | Approved | None posted |
| Apr 3, 1992 | Supplement 24Manufacturing | Approved | None posted |
| Jul 23, 1991 | Supplement 21Labeling | Approved | None posted |
| Apr 16, 1991 | Supplement 16Manufacturing | Approved | None posted |
| Apr 16, 1991 | Supplement 17Manufacturing | Approved | None posted |
| Apr 16, 1991 | Supplement 18Manufacturing | Approved | None posted |
| Apr 16, 1991 | Supplement 19Manufacturing | Approved | None posted |
| Aug 25, 1988 | Supplement 15Labeling | Approved | None posted |
| Oct 14, 1987 | Supplement 14Manufacturing | Approved | None posted |
| Mar 31, 1987 | Supplement 13Manufacturing | Approved | None posted |
| Dec 19, 1985 | Supplement 8Manufacturing | Approved | None posted |
| Jun 3, 1983 | Supplement 6Manufacturing | Approved | None posted |
| Jan 28, 1981 | Original application | 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
