ANDA 77236, held by Fougera Pharms. Prednicarbate.
As of Nov 14, 2026, ANDA 77236 (Prednicarbate), held by Fougera Pharms, was first approved by FDA on Mar 9, 2007, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 9, 2007 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prednicarbate0.1% · ointment;topical | Prednicarbate | Rx |
| Sep 25, 2015 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 9, 2007 | Original application | Approved |
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
