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FDA ANDA · ANDA090787

LEVOFLOXACIN

Sponsor: APOTEX INC

APPLICATION
ANDA090787
TYPE
ANDA
ORIGINAL APPROVAL
2011-09-29
LATEST ACTION
2024-09-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LEVOFLOXACINDiscontinued
LEVOFLOXACIN 500MG · TABLET · ORAL
LEVOFLOXACINDiscontinued
LEVOFLOXACIN 750MG · TABLET · ORAL
LEVOFLOXACINDiscontinued
LEVOFLOXACIN 250MG · TABLET · ORAL

Approval history

2024-09-20Labeling · Supplement 14 · standardAP
2021-02-11Labeling · Supplement 13 · standardAP
2020-06-02Labeling · Supplement 12 · standardAP
2020-06-02Labeling · Supplement 11 · standardAP
2019-05-06Labeling · Supplement 10 · standardAP
2019-04-24Labeling · Supplement 8 · standardAP
2019-04-24Labeling · Supplement 6 · standardAP
2019-04-24Labeling · Supplement 9 · standardAP
2019-04-24Labeling · Supplement 7 · standardAP
2014-09-24Labeling · Supplement 4 · standardAP
2014-09-24Labeling · Supplement 3 · standardAP
2013-07-31Labeling · Supplement 2 · standardAP
2013-07-22Labeling · Supplement 1 · standardAP
2011-09-29OriginalAP
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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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