Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 209411, held by Beach Prods. Clobetasol Propionate.
As of Nov 15, 2026, ANDA 209411 (Clobetasol Propionate (Emollient)), held by Beach Prods, was first approved by FDA on Aug 21, 2017, with 0 approved supplements and 0 published complete response letters.
Clobetasol propionate cream USP, 0.05% (emollient) is a corticosteroid indicated for: The relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older. The treatment of moderate to severe plaque-type psoriasis in patients 16 years of age and older. Limitations of Use Clobetasol propionate cream USP, 0.05% (emollient) should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae. The total dosage should not exceed 50 grams per week. Avoid use if skin atrophy is present at the treatment site. Clobetasol propionate cream USP, 0.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 21, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clobetasol Propionate (Emollient)0.05% · cream;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
