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Treats Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses. ANDA 219273, held by Qilu Pharm Hainan. Micafungin Sodium.
As of Nov 15, 2026, ANDA 219273 (Micafungin Sodium), held by Qilu Pharm Hainan, was first approved by FDA on Apr 3, 2025, with 0 approved supplements and 0 published complete response letters.
First approved: Apr 3, 2025
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
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.
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
