Relieves inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. ANDA 211764, held by Cosette Pharms Nc. Hydrocortisone Valerate.
As of Nov 15, 2026, ANDA 211764 (Hydrocortisone Valerate), held by Cosette Pharms Nc, was first approved by FDA on Mar 4, 2020, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Hydrocortisone valerate ointment USP, 0.2% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 4, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrocortisone Valerate0.2% · ointment;topical | Hydrocortisone Valerate | Rx |
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
