NDA 21554, held by Bayer Pharms. Ciprofloxacin; Ciprofloxacin Hydrochloride.
As of Nov 14, 2026, NDA 21554 (Cipro Xr), held by Bayer Pharms, was first approved by FDA on Aug 28, 2003, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 28, 2003 | Original applicationTYPE 6 · Standard review | Approved |
| Cipro Xr212.6MG; EQ 287.5MG BASE · tablet, extended release; oral | Ciprofloxacin; Ciprofloxacin Hydrochloride | Rx |
| Cipro Xr425.2MG; EQ 574.9MG BASE · tablet, extended release; oral | Ciprofloxacin; Ciprofloxacin Hydrochloride | 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
