NDA 8917, held by Pharmacia And Upjohn. Hydrocortisone Acetate.
As of Nov 13, 2026, NDA 8917 (Cortef Acetate), held by Pharmacia And Upjohn, was first approved by FDA on Jul 28, 1953, with 9 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 28, 1953 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cortef Acetate2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · ointment;topical | Hydrocortisone Acetate | DiscontinuedReference drug |
| Cortef Acetate1% · ointment;topical | Hydrocortisone Acetate | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 5, 1990 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Apr 28, 1987 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Apr 28, 1987 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Oct 14, 1982 | Supplement 17Labeling | Approved | None posted |
| Mar 19, 1980 | Supplement 16Labeling | Approved | None posted |
| Oct 11, 1977 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Feb 10, 1977 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Oct 12, 1976 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Jun 3, 1976 | Supplement 11Labeling | Approved | None posted |
| Jul 28, 1953 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
