APPLICATION
ANDA075685
TYPE
ANDA
ORIGINAL APPROVAL
2004-06-09
LATEST ACTION
2025-07-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CIPROFLOXACIN HYDROCHLORIDEDiscontinued
CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE · TABLET · ORAL
CIPROFLOXACIN HYDROCHLORIDEDiscontinued
CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE · TABLET · ORAL
CIPROFLOXACIN HYDROCHLORIDEDiscontinued
CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE · TABLET · ORAL
Approval history
2025-07-21Labeling · Supplement 16 · standardAP
2025-07-21Labeling · Supplement 14 · standardAP
2025-07-21Labeling · Supplement 20 · standardAP
2025-07-21Labeling · Supplement 19 · standardAP
2015-11-17Labeling · Supplement 12 · standardAP
2015-11-17Labeling · Supplement 13 · standardAP
2012-03-05Labeling · Supplement 11AP
2011-05-08Labeling · Supplement 10AP
2010-05-10Labeling · Supplement 8AP
2009-07-22Labeling · Supplement 7AP
2009-01-29Labeling · Supplement 6AP
2005-04-14Labeling · Supplement 1AP
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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