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FDA ANDA · ANDA078431
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor: HIKMA FARMACEUTICA
APPLICATION
ANDA078431
TYPE
ANDA
ORIGINAL APPROVAL
2009-11-18
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
Approval history
2024-09-20Labeling · Supplement 11 · standardAP
2019-05-03Labeling · Supplement 10 · standardAP
2019-04-16Labeling · Supplement 9 · standardAP
2018-10-18Labeling · Supplement 8 · standardAP
2018-10-15Labeling · Supplement 6 · standardAP
2018-10-15Labeling · Supplement 7 · standardAP
2014-06-25Labeling · Supplement 4 · standardAP
2011-07-07Labeling · Supplement 1AP
2009-11-18OriginalAP
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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