ANDA 87086, held by Pharmobedient. Spironolactone.
As of Nov 15, 2026, ANDA 87086 (Spironolactone), held by Pharmobedient, was first approved by FDA on Feb 3, 1981, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 3, 1981 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Spironolactone25MG ยท tablet;oral | Spironolactone | Discontinued |
| Sep 13, 2000 | Supplement 27Labeling | Approved | None posted |
| Apr 3, 2000 | Supplement 26Labeling | Approved | None posted |
| Aug 26, 1998 | Supplement 25Labeling | Approved | None posted |
| Feb 25, 1998 | Supplement 23Manufacturing | Approved | None posted |
| Feb 5, 1998 | Supplement 24Manufacturing | Approved | None posted |
| Jun 1, 1994 | Supplement 22Manufacturing | Approved | None posted |
| Jun 1, 1994 | Supplement 21Manufacturing | Approved | None posted |
| Jun 1, 1994 | Supplement 20Manufacturing | Approved | None posted |
| Jun 16, 1993 | Supplement 19Labeling | Approved | None posted |
| Dec 26, 1990 | Supplement 17Labeling | Approved | None posted |
| Jan 31, 1990 | Supplement 16Manufacturing | Approved | None posted |
| Nov 10, 1987 | Supplement 14Manufacturing | Approved | None posted |
| Oct 17, 1986 | Supplement 12Manufacturing | Approved | None posted |
| Apr 10, 1985 | Supplement 9Manufacturing | Approved | None posted |
| Sep 18, 1984 | Supplement 8Manufacturing | Approved | None posted |
| Dec 2, 1981 | Supplement 3Manufacturing | Approved | None posted |
| Feb 3, 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
