ANDA 218548, held by Yichang Humanwell. Fenofibrate.
As of Nov 14, 2026, ANDA 218548 (Fenofibrate), held by Yichang Humanwell, was first approved by FDA on Apr 24, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 24, 2024 | Original application | Approved | None posted |
| Fenofibrate54MG · tablet;oral | Fenofibrate | Rx |
| Fenofibrate160MG · tablet;oral | Fenofibrate | 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
