Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 76872, held by Padagis Israel. Halobetasol Propionate.
As of Nov 15, 2026, ANDA 76872 (Halobetasol Propionate), held by Padagis Israel, was first approved by FDA on Dec 16, 2004, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Halobetasol propionate ointment, 0.05% is a super-high potency corticosteroid indictated 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 16, 2004 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Halobetasol Propionate0.05% · ointment;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
