APPLICATION
ANDA076558
TYPE
ANDA
ORIGINAL APPROVAL
2004-06-09
LATEST ACTION
2026-07-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription
Products
CIPROFLOXACIN HYDROCHLORIDEDiscontinued
CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE · TABLET · ORAL
CIPROFLOXACINPrescription
CIPROFLOXACIN 250MG · TABLET · ORAL
CIPROFLOXACIN HYDROCHLORIDEDiscontinued
CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE · TABLET · ORAL
CIPROFLOXACIN HYDROCHLORIDEDiscontinued
CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE · TABLET · ORAL
Approval history
2026-07-22Labeling · Supplement 72 · standardAP
2023-08-31Labeling · Supplement 56 · standardAP
2023-08-31Labeling · Supplement 59 · standardAP
2023-08-31Labeling · Supplement 49 · standardAP
2023-08-31Labeling · Supplement 63 · standardAP
2023-08-31Labeling · Supplement 55 · standardAP
2023-08-31Labeling · Supplement 53 · standardAP
2023-08-31Labeling · Supplement 51 · standardAP
2018-11-07Labeling · Supplement 46 · standardAP
2018-11-07Labeling · Supplement 41 · standardAP
2015-09-21Labeling · Supplement 38 · standardAP
2015-09-21Labeling · Supplement 36 · standardAP
2015-09-21Labeling · Supplement 35 · standardAP
2014-10-31Manufacturing (CMC) · Supplement 22AP
2012-08-15Labeling · Supplement 34 · standardAP
2012-07-11Labeling · Supplement 33AP
2012-02-28Labeling · Supplement 31AP
2011-05-12Labeling · Supplement 27AP
2011-05-08Labeling · Supplement 28AP
2009-08-24Labeling · Supplement 21AP
2009-08-20Labeling · Supplement 19AP
2009-02-04Labeling · Supplement 4AP
2009-01-29Labeling · Supplement 17AP
2008-03-16Labeling · Supplement 14AP
2008-02-06Labeling · Supplement 13AP
2007-02-09Labeling · Supplement 12AP
2005-11-29Labeling · Supplement 8AP
2005-06-29Labeling · Supplement 7AP
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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