APPLICATION
ANDA202801
TYPE
ANDA
ORIGINAL APPROVAL
2015-01-08
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 16 · standardAP
2022-09-27Labeling · Supplement 13 · standardAP
2019-05-03Labeling · Supplement 5 · standardAP
2019-04-24Labeling · Supplement 4 · standardAP
2019-04-24Labeling · Supplement 3 · standardAP
2019-04-24Labeling · Supplement 1 · standardAP
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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