APPLICATION
NDA021554
TYPE
NDA
ORIGINAL APPROVAL
2003-08-28
LATEST ACTION
2003-08-28
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
CIPRO XRPrescription
CIPROFLOXACIN 212.6MG, CIPROFLOXACIN HYDROCHLORIDE EQ 287.5MG BASE · TABLET, EXTENDED RELEASE · ORAL
CIPRO XRPrescription
CIPROFLOXACIN 425.2MG, CIPROFLOXACIN HYDROCHLORIDE EQ 574.9MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.