ANDA 83398, held by Watson Labs. Prednisolone Acetate.
As of Nov 15, 2026, ANDA 83398 (Prednisolone Acetate), held by Watson Labs, was first approved by FDA on Feb 13, 1974, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 13, 1974 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prednisolone Acetate25MG/ML ยท injectable;injection | Prednisolone Acetate | Discontinued |
| Feb 19, 1999 | Supplement 143Manufacturing | Approved | None posted |
| Feb 2, 1999 | Supplement 142Manufacturing | Approved | None posted |
| May 27, 1998 | Supplement 141Manufacturing | Approved | None posted |
| Aug 6, 1997 | Supplement 140Manufacturing | Approved | None posted |
| May 9, 1991 | Supplement 138Labeling | Approved | None posted |
| Jan 11, 1991 | Supplement 135Manufacturing | Approved | None posted |
| Jan 11, 1991 | Supplement 136Manufacturing | Approved | None posted |
| Oct 26, 1989 | Supplement 137Labeling | Approved | None posted |
| Dec 30, 1988 | Supplement 131Bioequivalence | Approved | None posted |
| Dec 23, 1988 | Supplement 133Manufacturing | Approved | None posted |
| Dec 23, 1988 | Supplement 134Manufacturing | Approved | None posted |
| Jun 16, 1986 | Supplement 130Manufacturing | Approved | None posted |
| Oct 31, 1984 | Supplement 129Manufacturing | Approved | None posted |
| Jun 27, 1984 | Supplement 83Manufacturing | Approved | None posted |
| Jun 27, 1984 | Supplement 125Manufacturing | Approved | None posted |
| Jun 27, 1984 | Supplement 126Manufacturing | Approved | None posted |
| Feb 13, 1974 | 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
