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FDA ANDA · ANDA077859
CIPROFLOXACIN
ciprofloxacin hydrochloride
Sponsor: AUROBINDO PHARMA
APPLICATION
ANDA077859
TYPE
ANDA
ORIGINAL APPROVAL
2007-04-26
LATEST ACTION
2025-03-27
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
2025-03-27Manufacturing (CMC) · Supplement 46 · unknownAP
2024-08-29Labeling · Supplement 29 · standardAP
2024-08-29Labeling · Supplement 35 · standardAP
2024-08-29Labeling · Supplement 27 · standardAP
2024-08-29Labeling · Supplement 25 · standardAP
2024-08-29Labeling · Supplement 38 · standardAP
2024-08-29Labeling · Supplement 26 · standardAP
2024-08-29Labeling · Supplement 32 · standardAP
2024-08-29Labeling · Supplement 30 · standardAP
2024-02-09Manufacturing (CMC) · Supplement 44 · unknownAP
2015-10-06Labeling · Supplement 18 · standardAP
2015-10-06Labeling · Supplement 24 · standardAP
2014-04-01Manufacturing (CMC) · Supplement 15 · unknownAP
2013-04-24Labeling · Supplement 17 · standardAP
2012-03-28Labeling · Supplement 13AP
2012-02-27Labeling · Supplement 12AP
2011-12-08Labeling · Supplement 11AP
2011-05-08Labeling · Supplement 9AP
2011-02-23Manufacturing (CMC) · Supplement 6AP
2009-08-24Labeling · Supplement 7AP
2009-05-20Labeling · Supplement 5AP
2008-12-02Labeling · Supplement 4AP
2008-05-13Labeling · Supplement 3AP
2007-10-05Labeling · Supplement 1AP
2007-04-26OriginalAP
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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