APPLICATION
ANDA078424
TYPE
ANDA
ORIGINAL APPROVAL
2011-06-20
LATEST ACTION
2024-09-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LEVOFLOXACINDiscontinued
LEVOFLOXACIN 250MG · TABLET · ORAL
LEVOFLOXACINDiscontinued
LEVOFLOXACIN 500MG · TABLET · ORAL
LEVOFLOXACINDiscontinued
LEVOFLOXACIN 750MG · TABLET · ORAL
Approval history
2024-09-20Labeling · Supplement 22 · standardAP
2022-12-19Labeling · Supplement 21 · standardAP
2020-06-10Labeling · Supplement 20 · standardAP
2020-06-10Labeling · Supplement 19 · standardAP
2019-05-03Labeling · Supplement 18 · standardAP
2019-04-17Labeling · Supplement 14 · standardAP
2019-04-17Labeling · Supplement 17 · standardAP
2019-04-17Labeling · Supplement 13 · standardAP
2019-04-17Labeling · Supplement 16 · standardAP
2014-11-08Labeling · Supplement 10 · standardAP
2014-11-08Labeling · Supplement 11 · standardAP
2013-04-08Labeling · Supplement 8 · standardAP
2013-03-08Labeling · Supplement 7 · standardAP
2012-01-18Labeling · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.