ANDA 80339, held by Fosun Pharma. Prednisolone.
As of Nov 15, 2026, ANDA 80339 (Prednisolone), held by Fosun Pharma, was first approved by FDA on Sep 6, 1972, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 6, 1972 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prednisolone5MG · tablet;oral | Prednisolone | Discontinued |
| Jun 5, 2024 | Supplement 50Labeling · Standard review | Approved | None posted |
| Apr 4, 1994 | Supplement 49Labeling | Approved | None posted |
| Jan 24, 1994 | Supplement 48Manufacturing | Approved | None posted |
| May 10, 1990 | Supplement 47Labeling | Approved | None posted |
| Nov 2, 1989 | Supplement 46Labeling | Approved | None posted |
| Jul 12, 1989 | Supplement 45Labeling | Approved | None posted |
| Apr 7, 1988 | Supplement 44Manufacturing | Approved | None posted |
| Apr 7, 1988 | Supplement 43Manufacturing | Approved | None posted |
| Aug 9, 1985 | Supplement 42Manufacturing | Approved | None posted |
| Aug 9, 1985 | Supplement 41Manufacturing | Approved | None posted |
| Aug 9, 1985 | Supplement 40Manufacturing | Approved | None posted |
| Nov 5, 1982 | Supplement 36Manufacturing | Approved | None posted |
| Nov 5, 1982 | Supplement 35Manufacturing | Approved | None posted |
| Oct 13, 1982 | Supplement 34Manufacturing | Approved | None posted |
| Sep 7, 1982 | Supplement 33Manufacturing | Approved | None posted |
| Sep 7, 1982 | Supplement 32Manufacturing | Approved | None posted |
| Sep 6, 1972 | 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
