Relieves inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. ANDA 210199, held by Zydus Pharms. Clobetasol Propionate.
As of Nov 15, 2026, ANDA 210199 (Clobetasol Propionate), held by Zydus Pharms, was first approved by FDA on Oct 27, 2017, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Clobetasol propionate ointment is super-high potency corticosteroid formulations 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 |
|---|---|---|---|
| Oct 27, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clobetasol Propionate0.05% · ointment;topical | Clobetasol Propionate | Rx |
| Oct 7, 2022 | Supplement 6Labeling · Standard review | Approved | None posted |
| Oct 27, 2017 | Original application | Approved | None posted |
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
