ANDA 80336, held by Aiping Pharm Inc. Prednisone.
As of Nov 14, 2026, ANDA 80336 (Prednisone), held by Aiping Pharm Inc, was first approved by FDA on Jul 13, 1972, with 17 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 13, 1972 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prednisone5MG · tablet;oral | Prednisone | Discontinued |
| Jun 5, 2024 | Supplement 50Labeling · Standard review | Approved | None posted |
| Jan 24, 1994 | Supplement 49Manufacturing | Approved | None posted |
| Aug 3, 1989 | Supplement 51Labeling | Approved | None posted |
| Aug 3, 1989 | Supplement 48Labeling | Approved | None posted |
| Aug 11, 1987 | Supplement 45Manufacturing | Approved | None posted |
| Jun 15, 1987 | Supplement 44Manufacturing | Approved | None posted |
| Jul 30, 1986 | Supplement 42Manufacturing | Approved | None posted |
| Jul 30, 1986 | Supplement 41Manufacturing | Approved | None posted |
| Jul 30, 1986 | Supplement 40Manufacturing | Approved | None posted |
| Jul 30, 1986 | Supplement 39Manufacturing | Approved | None posted |
| Oct 1, 1984 | Supplement 37Manufacturing | Approved | None posted |
| Oct 1, 1984 | Supplement 36Manufacturing | Approved | None posted |
| Aug 23, 1984 | Supplement 34Manufacturing | Approved | None posted |
| Aug 23, 1984 | Supplement 33Manufacturing | Approved | None posted |
| Oct 12, 1982 | Supplement 32Manufacturing | Approved | None posted |
| May 17, 1982 | Supplement 29Manufacturing | Approved | None posted |
| Feb 26, 1982 | Supplement 31Manufacturing | Approved | None posted |
| Jul 13, 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
