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FDA ANDA · ANDA078024
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor: BAXTER HLTHCARE CORP
APPLICATION
ANDA078024
TYPE
ANDA
ORIGINAL APPROVAL
2008-03-18
LATEST ACTION
2024-09-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
CIPROFLOXACIN 200MG/100ML · INJECTABLE · INJECTION
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
CIPROFLOXACIN 400MG/200ML · INJECTABLE · INJECTION
Approval history
2024-09-20Labeling · Supplement 40 · standardAP
2024-09-09Labeling · Supplement 31 · standardAP
2024-09-09Labeling · Supplement 35 · standardAP
2019-05-06Labeling · Supplement 30 · standardAP
2019-05-06Labeling · Supplement 29 · standardAP
2018-10-18Labeling · Supplement 25 · standardAP
2018-10-15Labeling · Supplement 21 · standardAP
2017-01-27Labeling · Supplement 18 · standardAP
2017-01-27Labeling · Supplement 19 · standardAP
2016-06-07Labeling · Supplement 17 · standardAP
2016-06-07Labeling · Supplement 15 · standardAP
2016-06-07Labeling · Supplement 10 · standardAP
2012-09-18Labeling · Supplement 9 · standardAP
2012-05-21Labeling · Supplement 8AP
2011-05-16Labeling · Supplement 7AP
2010-01-26Labeling · Supplement 4AP
2009-05-26Labeling · Supplement 3AP
2009-01-29Labeling · 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.
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