APPLICATION
ANDA076361
TYPE
ANDA
ORIGINAL APPROVAL
2011-06-20
LATEST ACTION
2024-09-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LEVOFLOXACINPrescription
LEVOFLOXACIN 500MG · TABLET · ORAL
LEVOFLOXACINPrescription
LEVOFLOXACIN 750MG · TABLET · ORAL
LEVOFLOXACINPrescription
LEVOFLOXACIN 250MG · TABLET · ORAL
Approval history
2024-09-20Labeling · Supplement 17 · standardAP
2024-09-09Labeling · Supplement 16 · standardAP
2019-05-03Labeling · Supplement 13 · standardAP
2019-04-26Labeling · Supplement 12 · standardAP
2019-04-26Labeling · Supplement 10 · standardAP
2019-04-26Labeling · Supplement 11 · standardAP
2014-09-19Labeling · Supplement 8 · standardAP
2014-09-19Labeling · Supplement 9 · standardAP
2014-07-15Manufacturing (CMC) · Supplement 1AP
2012-10-22Labeling · Supplement 6 · standardAP
2012-05-24Labeling · Supplement 5 · standardAP
2012-02-10Labeling · Supplement 3AP
2011-10-20Labeling · Supplement 2AP
2011-06-20OriginalAP
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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