APPLICATION
ANDA204536
TYPE
ANDA
ORIGINAL APPROVAL
2015-12-21
LATEST ACTION
2025-05-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LINEZOLIDDiscontinued
LINEZOLID 600MG · TABLET · ORAL
Approval history
2025-05-08Labeling · Supplement 10 · standardAP
2024-04-30Labeling · Supplement 9 · standardAP
2024-04-30Labeling · Supplement 7 · standardAP
2024-04-30Labeling · Supplement 8 · standardAP
2018-12-21Labeling · Supplement 1 · standardAP
2018-12-21Labeling · 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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