Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 78162, held by Cosette Pharms Nc. Halobetasol Propionate.
As of Nov 15, 2026, ANDA 78162 (Halobetasol Propionate), held by Cosette Pharms Nc, was first approved by FDA on Apr 24, 2007, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Halobetasol Propionate Cream, 0.05% is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two 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 children 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 |
|---|---|---|---|
| Apr 24, 2007 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Halobetasol Propionate0.05% · cream;topical | Halobetasol 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
