APPLICATION
ANDA200222
TYPE
ANDA
ORIGINAL APPROVAL
2012-06-27
LATEST ACTION
2024-11-04
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
LINEZOLIDDiscontinued
LINEZOLID 600MG/300ML (2MG/ML) · SOLUTION · INTRAVENOUS
Approval history
2024-11-04Labeling · Supplement 6 · standardAP
2024-11-04Labeling · Supplement 5 · standardAP
2019-06-26Labeling · Supplement 4 · standardAP
2016-01-05Labeling · Supplement 3 · standardAP
2016-01-05Labeling · Supplement 1 · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.