APPLICATION
ANDA077245
TYPE
ANDA
ORIGINAL APPROVAL
2006-08-28
LATEST ACTION
2019-05-03
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CIPROFLOXACINDiscontinued
CIPROFLOXACIN 400MG/40ML (10MG/ML) · INJECTABLE · INJECTION
CIPROFLOXACINDiscontinued
CIPROFLOXACIN 200MG/20ML (10MG/ML) · INJECTABLE · INJECTION
Approval history
2019-05-03Labeling · Supplement 23 · standardAP
2018-10-18Labeling · Supplement 22 · standardAP
2018-10-15Labeling · Supplement 19 · standardAP
2018-10-15Labeling · Supplement 21 · standardAP
2016-05-05Labeling · Supplement 17 · standardAP
2014-06-27Labeling · Supplement 16 · standardAP
2012-03-08Labeling · Supplement 15AP
2011-06-23Labeling · Supplement 13AP
2009-06-19Labeling · Supplement 10AP
2009-01-14Labeling · Supplement 8AP
2008-07-22Labeling · Supplement 6AP
2007-10-05Labeling · Supplement 4AP
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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