APPLICATION
ANDA078061
TYPE
ANDA
ORIGINAL APPROVAL
2015-05-18
LATEST ACTION
2024-11-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LINEZOLIDDiscontinued
LINEZOLID 600MG · TABLET · ORAL
Approval history
2024-11-14Labeling · Supplement 8 · standardAP
2024-11-14Labeling · Supplement 4 · standardAP
2024-11-14Labeling · Supplement 9 · standardAP
2024-11-14Labeling · Supplement 5 · standardAP
2024-11-14Labeling · Supplement 3 · standardAP
2015-10-28Labeling · Supplement 2 · standardAP
2015-10-28Manufacturing (CMC) · Supplement 1 · unknownAP
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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