ANDA 76903, held by Fougera Pharms. Halobetasol Propionate.
As of Nov 15, 2026, ANDA 76903 (Halobetasol Propionate), held by Fougera Pharms, was first approved by FDA on Dec 16, 2004, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 16, 2004 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Halobetasol Propionate0.05% ยท ointment;topical | Halobetasol Propionate | Discontinued |
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