APPLICATION
ANDA090722
TYPE
ANDA
ORIGINAL APPROVAL
2011-06-20
LATEST ACTION
2024-09-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LEVOFLOXACINDiscontinued
LEVOFLOXACIN 750MG · TABLET · ORAL
LEVOFLOXACINDiscontinued
LEVOFLOXACIN 250MG · TABLET · ORAL
LEVOFLOXACINDiscontinued
LEVOFLOXACIN 500MG · TABLET · ORAL
Approval history
2024-09-20Labeling · Supplement 16 · standardAP
2023-06-21Labeling · Supplement 15 · standardAP
2019-05-03Labeling · Supplement 14 · standardAP
2019-04-17Labeling · Supplement 12 · standardAP
2019-04-17Labeling · Supplement 10 · standardAP
2019-04-17Labeling · Supplement 13 · standardAP
2019-04-17Labeling · Supplement 11 · standardAP
2014-11-08Labeling · Supplement 8 · standardAP
2014-11-08Labeling · Supplement 7 · standardAP
2012-07-25Labeling · Supplement 4 · standardAP
2012-01-23Labeling · Supplement 2AP
2011-11-02Labeling · Supplement 1AP
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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