APPLICATION
ANDA090466
TYPE
ANDA
ORIGINAL APPROVAL
2015-06-15
LATEST ACTION
2024-09-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GEMIFLOXACIN MESYLATEDiscontinued
GEMIFLOXACIN MESYLATE EQ 320MG BASE · TABLET · ORAL
Approval history
2024-09-20Labeling · Supplement 4 · standardAP
2024-03-20Labeling · Supplement 3 · standardAP
2017-11-17Labeling · Supplement 1 · standardAP
2017-11-17Labeling · Supplement 2 · standardAP
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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