Relieves inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. ANDA 213724, held by Cosette Pharms Nc. Hydrocortisone Valerate.
As of Nov 15, 2026, ANDA 213724 (Hydrocortisone Valerate), held by Cosette Pharms Nc, was first approved by FDA on Feb 11, 2021, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Hydrocortisone valerate cream 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 |
|---|---|---|---|
| Feb 11, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrocortisone Valerate0.2% · cream;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
