Treats Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses. ANDA 215381, held by Meitheal. Micafungin Sodium.
As of Nov 15, 2026, ANDA 215381 (Micafungin Sodium), held by Meitheal, was first approved by FDA on Sep 28, 2022, with 0 approved supplements and 0 published complete response letters.
Micafungin for Injection is indicated for: Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older. Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older. Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation. Micafungin for Injection is an echinocandin indicated in adult and pediatric patients for: Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 28, 2022 | 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
