NDA 9458, held by Impax Labs. Cortisone Acetate.
As of Nov 13, 2026, NDA 9458 (Cortisone Acetate), held by Impax Labs, was first approved by FDA on Sep 17, 2001, with 42 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 17, 2001 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cortisone Acetate25MG · tablet;oral | Cortisone Acetate | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 17, 2001 | Supplement 71Labeling | Approved | None posted |
| Sep 17, 2001 | Supplement 64Labeling | Approved | None posted |
| Sep 17, 2001 | Supplement 58Labeling | Approved | None posted |
| Sep 17, 2001 | Supplement 37Labeling | Approved | None posted |
| Sep 17, 2001 | Supplement 36Labeling | Approved | None posted |
| Sep 17, 2001 | Supplement 35Labeling | Approved | None posted |
| Sep 17, 2001 | Supplement 34Labeling | Approved | None posted |
| Sep 17, 2001 | Supplement 33Labeling | Approved | None posted |
| Sep 17, 2001 | Supplement 32Labeling | Approved | None posted |
| Sep 17, 2001 | Supplement 31Labeling | Approved | None posted |
| Sep 17, 2001 | Supplement 30Labeling | Approved | None posted |
| Sep 17, 2001 | Supplement 29Labeling | Approved | None posted |
| Sep 17, 2001 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Oct 6, 1993 | Supplement 73Labeling | Approved | None posted |
| Oct 3, 1991 | Supplement 72Labeling | Approved | None posted |
| May 21, 1981 | Supplement 68Labeling | Approved | None posted |
| Apr 7, 1981 | Supplement 69Labeling | Approved | None posted |
| Oct 29, 1979 | Supplement 66Labeling | Approved | None posted |
| Aug 21, 1979 | Supplement 65Labeling | Approved | None posted |
| Aug 21, 1979 | Supplement 63Labeling | Approved | None posted |
| Aug 21, 1979 | Supplement 62Labeling | Approved | None posted |
| Aug 21, 1979 | Supplement 61Labeling | Approved | None posted |
| Aug 21, 1979 | Supplement 60Labeling | Approved | None posted |
| Oct 30, 1978 | Supplement 59Labeling | Approved | None posted |
| Jun 7, 1978 | Supplement 56Labeling | Approved | None posted |
| Jun 7, 1978 | Supplement 55Labeling | Approved | None posted |
| May 3, 1978 | Supplement 57Labeling | Approved | None posted |
| Jan 9, 1978 | Supplement 53Labeling | Approved | None posted |
| Jan 9, 1978 | Supplement 52Labeling | Approved | None posted |
| Jan 9, 1978 | Supplement 51Labeling | Approved | None posted |
| Jan 9, 1978 | Supplement 50Labeling | Approved | None posted |
| Feb 23, 1977 | Supplement 49Labeling | Approved | None posted |
| Feb 23, 1977 | Supplement 48Labeling | Approved | None posted |
| Feb 23, 1977 | Supplement 47Labeling | Approved | None posted |
| Feb 23, 1977 | Supplement 46Labeling | Approved | None posted |
| Feb 23, 1977 | Supplement 45Labeling | Approved | None posted |
| Feb 23, 1977 | Supplement 44Labeling | Approved | None posted |
| Feb 23, 1977 | Supplement 43Labeling | Approved | None posted |
| Feb 23, 1977 | Supplement 42Labeling | Approved | None posted |
| Feb 23, 1977 | Supplement 41Labeling | Approved | None posted |
| Feb 23, 1977 | Supplement 40Labeling | Approved | None posted |
| Feb 23, 1977 | Supplement 39Labeling | Approved | None posted |
| Feb 23, 1977 | Supplement 38Labeling | 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
