ANDA 85628, held by Rising. Sulfisoxazole.
As of Nov 15, 2026, ANDA 85628 (Sulfisoxazole), held by Rising, was first approved by FDA on Jun 13, 1977, with 17 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 13, 1977 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sulfisoxazole500MG ยท tablet;oral | Sulfisoxazole | Discontinued |
| May 9, 2001 | Supplement 61Manufacturing | Approved | None posted |
| Jan 21, 2000 | Supplement 60Manufacturing | Approved | None posted |
| Aug 4, 1995 | Supplement 59Manufacturing | Approved | None posted |
| Dec 31, 1984 | Supplement 56Manufacturing | Approved | None posted |
| Dec 31, 1984 | Supplement 55Manufacturing | Approved | None posted |
| Dec 31, 1984 | Supplement 54Manufacturing | Approved | None posted |
| Aug 22, 1983 | Supplement 53Manufacturing | Approved | None posted |
| Jul 23, 1982 | Supplement 52Manufacturing | Approved | None posted |
| Jul 23, 1982 | Supplement 51Manufacturing | Approved | None posted |
| Jul 23, 1982 | Supplement 50Manufacturing | Approved | None posted |
| Apr 20, 1982 | Supplement 49Manufacturing | Approved | None posted |
| Apr 20, 1982 | Supplement 42Manufacturing | Approved | None posted |
| Apr 20, 1982 | Supplement 41Manufacturing | Approved | None posted |
| Apr 20, 1982 | Supplement 40Manufacturing | Approved | None posted |
| Apr 20, 1982 | Supplement 30Manufacturing | Approved | None posted |
| Apr 20, 1982 | Supplement 29Manufacturing | Approved | None posted |
| Apr 20, 1982 | Supplement 28Manufacturing | Approved | None posted |
| Jun 13, 1977 | 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
