Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 207133, held by Padagis Israel. Flurandrenolide.
As of Nov 15, 2026, ANDA 207133 (Flurandrenolide), held by Padagis Israel, was first approved by FDA on Aug 30, 2016, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Flurandrenolide Lotion USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 30, 2016 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Flurandrenolide0.05% · lotion;topical | Flurandrenolide | 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
