ANDA 216506, held by Hangzhou Zhongmei. Caspofungin Acetate.
As of Nov 15, 2026, ANDA 216506 (Caspofungin Acetate), held by Hangzhou Zhongmei, was first approved by FDA on Jul 18, 2025, with 0 approved supplements and 0 published complete response letters.
Caspofungin acetate for injection is an echinocandin antifungal indicated in adults and pediatric patients (3 months of age and older) for: Empirical therapy for presumed fungal infections in febrile, neutropenic patients. Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. Treatment of esophageal candidiasis. Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 18, 2025 | Original application | Approved | None posted |
| Caspofungin Acetate50MG/VIAL · powder;intravenous | Caspofungin Acetate | Rx |
| Caspofungin Acetate70MG/VIAL · powder;intravenous | Caspofungin Acetate | 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
