Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 208841, held by Novel Labs Inc. Clobetasol Propionate.
As of Nov 15, 2026, ANDA 208841 (Clobetasol Propionate), held by Novel Labs Inc, was first approved by FDA on May 4, 2018, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Clobetasol propionate ointment USP is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 4, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clobetasol Propionate0.05% · ointment;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
