ANDA 74489, held by Cosette Pharms Nc. Hydrocortisone Valerate.
As of Nov 15, 2026, ANDA 74489 (Hydrocortisone Valerate), held by Cosette Pharms Nc, was first approved by FDA on Aug 12, 1998, with 6 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 12, 1998 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrocortisone Valerate0.2% ยท cream;topical | Hydrocortisone Valerate | Discontinued |
| Jan 23, 2002 | Supplement 3Manufacturing | Approved | None posted |
| Oct 31, 2001 | Supplement 4Manufacturing | Approved | None posted |
| Oct 31, 2001 | Supplement 5Manufacturing | Approved | None posted |
| Oct 31, 2001 | Supplement 6Manufacturing | Approved | None posted |
| Feb 26, 2001 | Supplement 2Manufacturing | Approved | None posted |
| Mar 23, 1999 | Supplement 1Manufacturing | Approved | None posted |
| Aug 12, 1998 | Original application | Approved |
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
