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FDA ANDA · ANDA077753
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor: HOSPIRA
APPLICATION
ANDA077753
TYPE
ANDA
ORIGINAL APPROVAL
2008-03-18
LATEST ACTION
2024-09-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERPrescription
CIPROFLOXACIN 400MG/200ML · INJECTABLE · INJECTION
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERPrescription
CIPROFLOXACIN 200MG/100ML · INJECTABLE · INJECTION
Approval history
2024-09-20Labeling · Supplement 25 · standardAP
2023-04-05Labeling · Supplement 23 · standardAP
2023-04-05Labeling · Supplement 21 · standardAP
2023-04-05Labeling · Supplement 22 · standardAP
2019-05-03Labeling · Supplement 20 · standardAP
2018-10-18Labeling · Supplement 19 · standardAP
2018-10-15Labeling · Supplement 15 · standardAP
2018-10-15Labeling · Supplement 18 · standardAP
2016-05-05Labeling · Supplement 14 · standardAP
2014-06-27Labeling · Supplement 13 · standardAP
2012-03-15Labeling · Supplement 11AP
2011-07-26Labeling · Supplement 8AP
2009-09-15Labeling · Supplement 5AP
2009-06-19Labeling · Supplement 3AP
2009-01-14Labeling · 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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