FDA approval · Drugs@FDA
CIPRO XRciprofloxacin, ciprofloxacin hydrochloride
NDA021554 ·
FDA approved the original new drug application for CIPRO XR on August 28, 2003, sponsored by BAYER PHARMS. FDA’s record shows no approved efficacy supplement on the application since.
- Application
- NDA021554
- Sponsor
- BAYER PHARMS
- Original approval
- Review
- standard review
- Submission class
- Type 6 - New Indication (no longer used)
- Active ingredient
- ciprofloxacin, ciprofloxacin hydrochloride
Browse every approval whose brand starts with C, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| ciprofloxacin 212.6MG; ciprofloxacin hydrochloride EQ 287.5MG BASE | TABLET, EXTENDED RELEASE | ORAL | Prescription |
| ciprofloxacin 425.2MG; ciprofloxacin hydrochloride EQ 574.9MG BASE | TABLET, EXTENDED RELEASE | ORAL | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
FDA’s record shows no approved efficacy supplement on this application.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
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