NDA 8228, held by Merck. Hydrocortisone Acetate.
As of Nov 13, 2026, NDA 8228 (Hydrocortone), held by Merck, was first approved by FDA on Dec 21, 1951, with 10 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 21, 1951 | Original applicationNew active ingredient · Standard review | Approved | None posted |
| Hydrocortone25MG/ML · injectable;injection | Hydrocortisone Acetate | Discontinued |
| Hydrocortone50MG/ML · injectable;injection | Hydrocortisone Acetate | Discontinued |
| Mar 1, 1996 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Mar 10, 1995 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1993 | Supplement 27Labeling · Standard review | Approved | None posted |
| Feb 12, 1992 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| May 16, 1989 | Supplement 19Labeling · Standard review | Approved | None posted |
| Sep 30, 1985 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Oct 3, 1984 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Mar 4, 1982 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Oct 16, 1981 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Aug 15, 1979 | Supplement 13Labeling · Standard review | Approved | None posted |
| Dec 21, 1951 | Original applicationNew active ingredient · Standard review | 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
