Treats Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses. ANDA 215241, held by Zydus Pharms. Micafungin Sodium.
As of Nov 15, 2026, ANDA 215241 (Micafungin Sodium), held by Zydus Pharms, was first approved by FDA on Oct 24, 2022, with 1 approved supplement 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 Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age. 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 24, 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 |
| Oct 23, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 24, 2022 | Original application | Approved | None posted |
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
