APPLICATION
ANDA202328
TYPE
ANDA
ORIGINAL APPROVAL
2013-01-24
LATEST ACTION
2024-09-20
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
LEVOFLOXACINDiscontinued
LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) · INJECTABLE · INJECTION
LEVOFLOXACINDiscontinued
LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) · INJECTABLE · INJECTION
Approval history
2024-09-20Labeling · Supplement 14 · standardAP
2019-05-03Labeling · Supplement 10 · standardAP
2018-10-18Labeling · Supplement 9 · standardAP
2018-10-15Labeling · Supplement 7 · standardAP
2018-10-15Labeling · Supplement 8 · standardAP
2016-07-15Labeling · Supplement 6 · standardAP
2014-02-28Labeling · Supplement 5 · standardAP
2013-11-05Labeling · Supplement 3 · standardAP
2013-01-24OriginalAP
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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