Treats moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA). ANDA 208842, held by Sun Pharma Canada. Clobetasol Propionate.
As of Nov 15, 2026, ANDA 208842 (Clobetasol Propionate), held by Sun Pharma Canada, was first approved by FDA on Mar 26, 2018, with 0 approved supplements and 0 published complete response letters.
1. INDICATIONS AND USAGE Clobetasol Propionate Topical Spray, 0.05% is a corticosteroid indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. Limitations of Use: Do not use on the face, axillae or groin. Do not use if atrophy is present at the treatment site. Do not use for rosacea or perioral dermatitis. 1.1 Indication Clobetasol Propionate Topical Spray, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 26, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clobetasol Propionate0.05% · spray;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
