APPLICATION
ANDA076639
TYPE
ANDA
ORIGINAL APPROVAL
2004-09-10
LATEST ACTION
2025-12-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CIPROFLOXACIN HYDROCHLORIDEPrescription
CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE · TABLET · ORAL
CIPROFLOXACIN HYDROCHLORIDEPrescription
CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE · TABLET · ORAL
CIPROFLOXACIN HYDROCHLORIDEPrescription
CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE · TABLET · ORAL
Approval history
2025-12-17Labeling · Supplement 33 · standardAP
2022-12-19Labeling · Supplement 18 · standardAP
2022-12-19Labeling · Supplement 30 · standardAP
2022-12-19Labeling · Supplement 22 · standardAP
2022-12-19Labeling · Supplement 14 · standardAP
2022-12-19Labeling · Supplement 29 · standardAP
2022-12-19Labeling · Supplement 27 · standardAP
2022-12-19Labeling · Supplement 19 · standardAP
2022-12-19Labeling · Supplement 23 · standardAP
2022-12-19Labeling · Supplement 15 · standardAP
2022-12-19Labeling · Supplement 13 · standardAP
2015-09-29Labeling · Supplement 11 · standardAP
2015-09-29Labeling · Supplement 12 · standardAP
2013-04-22Labeling · Supplement 10 · standardAP
2012-07-25Labeling · Supplement 9 · standardAP
2012-03-29Labeling · Supplement 8AP
2011-11-28Labeling · Supplement 7AP
2011-05-16Labeling · Supplement 6AP
2010-03-09Labeling · Supplement 2AP
2004-09-10OriginalAP
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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