APPLICATION
ANDA076717
TYPE
ANDA
ORIGINAL APPROVAL
2009-12-22
LATEST ACTION
2024-09-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CIPROFLOXACINPrescription
CIPROFLOXACIN 200MG/20ML (10MG/ML) · INJECTABLE · INJECTION
CIPROFLOXACINPrescription
CIPROFLOXACIN 400MG/40ML (10MG/ML) · INJECTABLE · INJECTION
Approval history
2024-09-20Labeling · Supplement 8 · standardAP
2019-05-03Labeling · Supplement 7 · standardAP
2019-04-16Labeling · Supplement 6 · standardAP
2018-10-18Labeling · Supplement 5 · standardAP
2018-10-15Labeling · Supplement 3 · standardAP
2018-10-15Labeling · Supplement 4 · standardAP
2014-06-25Labeling · Supplement 2 · standardAP
2011-06-23Labeling · Supplement 1AP
2009-12-22OriginalAP
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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