APPLICATION
ANDA076896
TYPE
ANDA
ORIGINAL APPROVAL
2004-11-04
LATEST ACTION
2025-09-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CIPROFLOXACIN HYDROCHLORIDEPrescription
CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE · TABLET · ORAL
CIPROFLOXACIN HYDROCHLORIDEPrescription
CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE · TABLET · ORAL
CIPROFLOXACIN HYDROCHLORIDEPrescription
CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE · TABLET · ORAL
Approval history
2025-09-30Labeling · Supplement 18 · standardAP
2025-09-30Labeling · Supplement 22 · standardAP
2025-09-30Labeling · Supplement 20 · standardAP
2025-09-30Labeling · Supplement 29 · standardAP
2025-09-30Labeling · Supplement 27 · standardAP
2025-09-30Labeling · Supplement 19 · standardAP
2025-09-30Labeling · Supplement 23 · standardAP
2025-09-30Labeling · Supplement 21 · standardAP
2015-10-06Labeling · Supplement 16 · standardAP
2015-10-06Labeling · Supplement 17 · standardAP
2013-04-25Labeling · Supplement 15 · standardAP
2012-05-01Labeling · Supplement 14AP
2012-01-11Labeling · Supplement 12AP
2010-03-25REMS · Supplement 11AP
2009-07-16Labeling · Supplement 10AP
2009-03-20Labeling · Supplement 9AP
2008-09-16Labeling · Supplement 8AP
2007-07-23Labeling · Supplement 3AP
2007-07-09Labeling · Supplement 6AP
2007-07-09Labeling · Supplement 4AP
2007-07-09Labeling · Supplement 5AP
2005-06-29Labeling · Supplement 1AP
2004-11-04OriginalAP
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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