ANDA 200833, held by Hengrui Pharma. Caspofungin Acetate.
As of Nov 15, 2026, ANDA 200833 (Caspofungin Acetate), held by Hengrui Pharma, was first approved by FDA on Jun 28, 2018, with 2 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 |
|---|---|---|---|
| Jun 28, 2018 | Original application | Approved | None posted |
| Caspofungin Acetate50MG/VIAL · powder;intravenous | Caspofungin Acetate | Discontinued |
| Caspofungin Acetate70MG/VIAL · powder;intravenous | Caspofungin Acetate | Discontinued |
| Sep 4, 2024 | Supplement 7Labeling · Standard review | Approved | None posted |
| Aug 2, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jun 28, 2018 | 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
