ANDA 75085, held by Fougera Pharms. Hydrocortisone Valerate.
As of Nov 15, 2026, ANDA 75085 (Hydrocortisone Valerate), held by Fougera Pharms, was first approved by FDA on Jul 31, 2001, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 31, 2001 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrocortisone Valerate0.2% ยท ointment;topical | Hydrocortisone Valerate | Discontinued |
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
