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FDA NDA · NDA021554

CIPRO XR

Sponsor: BAYER PHARMS

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

2003-08-28Type 6 - New Indication (no longer used) · Original · standardOtherAP
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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.

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