ANDA 78548, held by Fougera Pharms. Imiquimod.
As of Nov 14, 2026, ANDA 78548 (Imiquimod), held by Fougera Pharms, was first approved by FDA on Feb 25, 2010, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 25, 2010 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Imiquimod5% · cream;topical | Imiquimod | Rx |
| May 19, 2025 | Supplement 13Labeling · Standard review | Approved | None posted |
| Sep 18, 2015 | Supplement 2Labeling | Approved | None posted |
| Sep 18, 2015 | Supplement 7Labeling · Standard review | Approved | None posted |
| Feb 25, 2010 | 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
