ANDA 76484, held by Fresenius Kabi USA. Ciprofloxacin.
As of Nov 15, 2026, ANDA 76484 (Ciprofloxacin), held by Fresenius Kabi USA, was first approved by FDA on Aug 28, 2006, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 28, 2006 | Original application | Approved |
| Ciprofloxacin200MG/20ML (10MG/ML) · injectable;injection | Ciprofloxacin | Discontinued |
| Ciprofloxacin400MG/40ML (10MG/ML) · injectable;injection | Ciprofloxacin | Discontinued |
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
