APPLICATION
ANDA076093
TYPE
ANDA
ORIGINAL APPROVAL
2003-09-02
LATEST ACTION
2019-05-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription
Products
OFLOXACINDiscontinued
OFLOXACIN 300MG · TABLET · ORAL
OFLOXACINPrescription
OFLOXACIN 400MG · TABLET · ORAL
OFLOXACINDiscontinued
OFLOXACIN 200MG · TABLET · ORAL
Approval history
2019-05-22Labeling · Supplement 11 · standardAP
2018-10-18Labeling · Supplement 10 · standardAP
2016-07-26Labeling · Supplement 9 · standardAP
2015-11-04Labeling · Supplement 3AP
2015-10-26Manufacturing (CMC) · Supplement 8 · unknownAP
2015-03-20Labeling · Supplement 7 · standardAP
2015-03-05Manufacturing (CMC) · Supplement 5 · unknownAP
2014-12-22Labeling · Supplement 6 · standardAP
2005-04-22Labeling · Supplement 2AP
2005-04-05Labeling · 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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