Relieves inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. ANDA 211047, held by Encube Ethicals. Hydrocortisone Valerate.
As of Nov 15, 2026, ANDA 211047 (Hydrocortisone Valerate), held by Encube Ethicals, was first approved by FDA on Nov 4, 2021, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Hydrocortisone valerate cream USP, 0.2% is medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 4, 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
