Relieves inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. ANDA 210307, held by Lupin. Hydrocortisone Valerate.
As of Nov 15, 2026, ANDA 210307 (Hydrocortisone Valerate), held by Lupin, was first approved by FDA on Aug 15, 2019, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Hydrocortisone valerate cream USP 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 |
|---|---|---|---|
| Aug 15, 2019 | 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
