APPLICATION
ANDA078062
TYPE
ANDA
ORIGINAL APPROVAL
2008-04-29
LATEST ACTION
2019-05-06
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
2019-05-06Labeling · Supplement 18 · standardAP
2019-05-06Labeling · Supplement 17 · standardAP
2018-10-18Labeling · Supplement 16 · standardAP
2018-10-15Labeling · Supplement 15 · standardAP
2017-01-27Labeling · Supplement 14 · standardAP
2017-01-27Labeling · Supplement 13 · standardAP
2016-06-07Labeling · Supplement 12 · standardAP
2016-06-07Labeling · Supplement 10 · standardAP
2016-06-07Labeling · Supplement 9 · standardAP
2012-09-26Labeling · Supplement 8 · standardAP
2012-05-24Labeling · Supplement 7AP
2011-05-16Labeling · Supplement 6AP
2010-01-29Labeling · Supplement 3AP
2009-05-26Labeling · Supplement 2AP
2009-01-29Labeling · Supplement 1AP
2008-04-29OriginalAP
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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