ANDA 207092, held by Gland. Caspofungin Acetate.
As of Nov 15, 2026, ANDA 207092 (Caspofungin Acetate), held by Gland, was first approved by FDA on Sep 29, 2017, 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 |
|---|---|---|---|
| Sep 29, 2017 | Original application | Approved |
| Caspofungin Acetate50MG/VIAL · powder;intravenous | Caspofungin Acetate | Rx |
| Caspofungin Acetate70MG/VIAL · powder;intravenous | Caspofungin Acetate | Rx |
| Sep 5, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Sep 5, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 29, 2017 | Original application | Approved |
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
