ANDA 219518, held by Yichang Humanwell. Micafungin Sodium.
As of Nov 15, 2026, ANDA 219518 (Micafungin Sodium), held by Yichang Humanwell, was first approved by FDA on Feb 24, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 24, 2026 | Original application | Approved | None posted |
| Micafungin SodiumEQ 50MG BASE/VIAL · injectable;intravenous | Micafungin Sodium | Rx |
| Micafungin SodiumEQ 100MG BASE/VIAL · injectable;intravenous | Micafungin Sodium | 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
