APPLICATION
ANDA076089
TYPE
ANDA
ORIGINAL APPROVAL
2004-06-09
LATEST ACTION
2026-05-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, None (Tentative Approval)
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
CIPROFLOXACINNone (Tentative Approval)
CIPROFLOXACIN 100MG · TABLET · ORAL
Approval history
2026-05-19Labeling · Supplement 54 · standardAP
2022-12-19Labeling · Supplement 53 · standardAP
2022-12-19Labeling · Supplement 51 · standardAP
2022-12-19Labeling · Supplement 48 · standardAP
2022-12-19Labeling · Supplement 46 · standardAP
2022-12-19Labeling · Supplement 52 · standardAP
2022-12-19Labeling · Supplement 44 · standardAP
2022-12-19Labeling · Supplement 49 · standardAP
2016-04-19Labeling · Supplement 45 · standardAP
2013-04-24Labeling · Supplement 42 · standardAP
2012-03-13Labeling · Supplement 40AP
2011-11-28Labeling · Supplement 38AP
2011-05-08Labeling · Supplement 37AP
2009-09-28Labeling · Supplement 31AP
2009-05-20Labeling · Supplement 29AP
2008-12-02Labeling · Supplement 28AP
2008-03-16Labeling · Supplement 27AP
2008-03-10Labeling · Supplement 22AP
2008-02-29Labeling · Supplement 24AP
2008-02-06Labeling · Supplement 26AP
2006-10-22Labeling · Supplement 19AP
2005-11-29Labeling · Supplement 15AP
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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