APPLICATION
ANDA078252
TYPE
ANDA
ORIGINAL APPROVAL
2008-03-18
LATEST ACTION
2024-09-26
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERPrescription
CIPROFLOXACIN 200MG/100ML · INJECTABLE · INJECTION
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERPrescription
CIPROFLOXACIN 400MG/200ML · INJECTABLE · INJECTION
Approval history
2024-09-26Labeling · Supplement 40 · standardAP
2024-09-23Labeling · Supplement 33 · standardAP
2024-09-23Labeling · Supplement 38 · standardAP
2019-05-03Labeling · Supplement 32 · standardAP
2019-04-16Labeling · Supplement 30 · standardAP
2019-04-16Labeling · Supplement 31 · standardAP
2018-10-18Labeling · Supplement 29 · standardAP
2016-06-23Labeling · Supplement 22 · standardAP
2014-04-28Labeling · Supplement 16 · standardAP
2013-06-17Labeling · Supplement 13 · standardAP
2012-03-13Labeling · Supplement 10AP
2011-06-23Labeling · Supplement 7AP
2009-10-05Labeling · Supplement 5AP
2009-06-19Labeling · Supplement 4AP
2008-12-19Labeling · Supplement 1AP
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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