APPLICATION
ANDA091678
TYPE
ANDA
ORIGINAL APPROVAL
2011-06-20
LATEST ACTION
2024-09-20
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LEVOFLOXACINPrescription
LEVOFLOXACIN 250MG/10ML · SOLUTION · ORAL
Approval history
2024-09-20Labeling · Supplement 12 · standardAP
2019-05-23Labeling · Supplement 6 · standardAP
2019-05-22Labeling · Supplement 4 · standardAP
2018-10-18Labeling · Supplement 5 · standardAP
2015-02-11Manufacturing (CMC) · Supplement 3AP
2013-03-08Labeling · Supplement 2AP
2011-12-05Labeling · 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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