APPLICATION
ANDA078183
TYPE
ANDA
ORIGINAL APPROVAL
2007-03-22
LATEST ACTION
2024-09-20
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
CIPROFLOXACIN EXTENDED RELEASEDiscontinued
CIPROFLOXACIN 212.6MG, CIPROFLOXACIN HYDROCHLORIDE EQ 287.5MG BASE · TABLET, EXTENDED RELEASE · ORAL
CIPROFLOXACIN EXTENDED RELEASEDiscontinued
CIPROFLOXACIN 425.2MG, CIPROFLOXACIN HYDROCHLORIDE EQ 574.9MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-09-20Labeling · Supplement 25 · standardAP
2024-09-12Labeling · Supplement 24 · standardAP
2024-09-12Labeling · Supplement 22 · standardAP
2019-05-03Labeling · Supplement 21 · standardAP
2019-04-26Labeling · Supplement 20 · standardAP
2019-04-26Labeling · Supplement 18 · standardAP
2018-10-18Labeling · Supplement 19 · standardAP
2017-01-24Labeling · Supplement 16 · standardAP
2016-07-26Labeling · Supplement 14 · standardAP
2016-07-18Labeling · Supplement 13 · standardAP
2013-08-14Labeling · Supplement 11 · standardAP
2013-08-02Labeling · Supplement 9 · standardAP
2012-03-13Labeling · Supplement 8AP
2011-05-08Labeling · Supplement 6AP
2009-07-21Labeling · Supplement 4AP
2008-12-02Labeling · Supplement 3AP
2007-11-28Labeling · Supplement 2AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.