APPLICATION
ANDA091656
TYPE
ANDA
ORIGINAL APPROVAL
2014-09-18
LATEST ACTION
2019-10-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
OFLOXACINPrescription
OFLOXACIN 300MG · TABLET · ORAL
OFLOXACINPrescription
OFLOXACIN 400MG · TABLET · ORAL
OFLOXACINPrescription
OFLOXACIN 200MG · TABLET · ORAL
Approval history
2019-10-16Labeling · Supplement 5 · standardAP
2018-10-18Labeling · Supplement 4 · standardAP
2016-07-26Labeling · Supplement 2 · standardAP
2014-09-18Not Applicable · OriginalAP
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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