APPLICATION
ANDA201043
TYPE
ANDA
ORIGINAL APPROVAL
2011-06-20
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 34 · standardAP
2020-10-19Labeling · Supplement 21 · standardAP
2020-10-19Labeling · Supplement 28 · standardAP
2020-10-19Labeling · Supplement 22 · standardAP
2019-05-06Labeling · Supplement 18 · standardAP
2019-04-24Labeling · Supplement 12 · standardAP
2019-04-24Labeling · Supplement 15 · standardAP
2019-04-24Labeling · Supplement 11 · standardAP
2019-04-24Labeling · Supplement 16 · standardAP
2019-04-24Labeling · Supplement 14 · standardAP
2015-10-08Labeling · Supplement 7 · standardAP
2015-10-08Labeling · Supplement 9 · standardAP
2012-07-25Labeling · Supplement 5 · standardAP
2012-03-29REMS · Supplement 4AP
2012-01-19Labeling · Supplement 2AP
2011-10-20Labeling · Supplement 1AP
2011-06-20Not 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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