APPLICATION
ANDA075817
TYPE
ANDA
ORIGINAL APPROVAL
2004-06-09
LATEST ACTION
2025-01-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription
Products
CIPROFLOXACIN HYDROCHLORIDEDiscontinued
CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE · TABLET · ORAL
CIPROFLOXACIN HYDROCHLORIDEDiscontinued
CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE · TABLET · ORAL
CIPROFLOXACIN HYDROCHLORIDEPrescription
CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE · TABLET · ORAL
Approval history
2025-01-29Labeling · Supplement 43 · standardAP
2015-08-12Manufacturing (CMC) · Supplement 33 · unknownAP
2015-07-02Labeling · Supplement 32 · standardAP
2015-07-02Labeling · Supplement 30 · standardAP
2014-08-12Labeling · Supplement 15AP
2013-10-25Labeling · Supplement 26AP
2013-10-25Labeling · Supplement 29 · standardAP
2011-05-16Labeling · Supplement 25AP
2010-05-19Labeling · Supplement 22AP
2010-05-10Labeling · Supplement 19AP
2009-07-22Labeling · Supplement 17AP
2008-12-04Labeling · Supplement 11AP
2008-09-16Labeling · Supplement 9AP
2007-06-25Labeling · Supplement 8AP
2006-10-05Labeling · Supplement 4AP
2004-06-09OriginalAP
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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