ANDA 77287, held by Fougera Pharms. Prednicarbate.
As of Nov 14, 2026, ANDA 77287 (Prednicarbate), held by Fougera Pharms, was first approved by FDA on Sep 19, 2006, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 19, 2006 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prednicarbate0.1% · cream;topical | Prednicarbate | Discontinued |
| Oct 2, 2015 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 19, 2006 | 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
