ANDA 208366, held by Apotex. Micafungin Sodium.
As of Nov 15, 2026, ANDA 208366 (Micafungin Sodium), held by Apotex, was first approved by FDA on Nov 5, 2020, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 5, 2020 | Original application | Approved |
| Micafungin SodiumEQ 50MG BASE/VIAL · injectable;intravenous | Micafungin Sodium | Discontinued |
| Micafungin SodiumEQ 100MG BASE/VIAL · injectable;intravenous | Micafungin Sodium | Discontinued |
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
