NDA 50202, held by Parkedale. Chloramphenicol; Hydrocortisone Acetate.
As of Nov 14, 2026, NDA 50202 (Chloromycetin Hydrocortisone), held by Parkedale, was first approved by FDA on Dec 9, 1953, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 9, 1953 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Chloromycetin Hydrocortisone12.5MG/VIAL;25MG/VIAL ยท for suspension;ophthalmic | Chloramphenicol; Hydrocortisone Acetate | Discontinued |
| Sep 25, 1992 | Supplement 7Manufacturing | Approved | None posted |
| Apr 6, 1992 | Supplement 6Manufacturing | Approved | None posted |
| Sep 29, 1986 | Supplement 5Manufacturing | Approved | None posted |
| Sep 17, 1984 | Supplement 4Manufacturing | Approved | None posted |
| Nov 8, 1983 | Supplement 1Labeling | Approved | None posted |
| Sep 28, 1982 | Supplement 17Manufacturing | Approved | None posted |
| Jul 7, 1982 | Supplement 16Labeling | Approved | None posted |
| Dec 2, 1980 | Supplement 15Labeling | Approved | None posted |
| May 29, 1980 | Supplement 14Labeling | Approved | None posted |
| Aug 3, 1978 | Supplement 13Manufacturing | Approved | None posted |
| Feb 23, 1977 | Supplement 12Manufacturing | Approved | None posted |
| Aug 16, 1956 | Supplement 10Manufacturing | Approved | None posted |
| Jun 12, 1956 | Supplement 9Manufacturing | Approved | None posted |
| May 11, 1954 | Supplement 2Manufacturing | Approved | None posted |
| Apr 8, 1954 | Supplement 3Manufacturing | Approved | None posted |
| Dec 9, 1953 | 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
