Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses…. ANDA 210639, held by Xiromed. Betamethasone Valerate.
As of Nov 15, 2026, ANDA 210639 (Betamethasone Valerate), held by Xiromed, was first approved by FDA on Apr 18, 2023, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Betamethasone valerate foam, 0.12% is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 18, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Betamethasone Valerate0.12% · aerosol, foam;topical | Betamethasone 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