APPLICATION
ANDA077652
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-07
LATEST ACTION
2024-09-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LEVOFLOXACINPrescription
LEVOFLOXACIN 750MG · TABLET · ORAL
LEVOFLOXACINPrescription
LEVOFLOXACIN 250MG · TABLET · ORAL
LEVOFLOXACINPrescription
LEVOFLOXACIN 500MG · TABLET · ORAL
Approval history
2024-09-20Labeling · Supplement 20 · standardAP
2023-06-28Labeling · Supplement 18 · standardAP
2022-04-04Manufacturing (CMC) · Supplement 19 · unknownAP
2020-05-29Labeling · Supplement 17 · standardAP
2019-05-03Labeling · Supplement 16 · standardAP
2019-04-16Labeling · Supplement 15 · standardAP
2019-04-16Labeling · Supplement 8 · standardAP
2019-04-16Labeling · Supplement 14 · standardAP
2019-04-16Labeling · Supplement 10 · standardAP
2014-09-25Labeling · Supplement 3 · standardAP
2014-09-25Labeling · Supplement 2 · standardAP
2012-09-07OriginalAP
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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