Treats inflammatory and pruritic manifestations of moderate to severe…. ANDA 212881, held by Alembic. Clobetasol Propionate.
As of Nov 15, 2026, ANDA 212881 (Clobetasol Propionate), held by Alembic, was first approved by FDA on Oct 21, 2019, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Clobetasol Propionate Topical Solution USP, 0.05% is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 21, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clobetasol Propionate0.05% · solution;topical | Clobetasol Propionate | 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
