APPLICATION
ANDA205442
TYPE
ANDA
ORIGINAL APPROVAL
2015-07-07
LATEST ACTION
2019-06-21
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
LINEZOLIDDiscontinued
LINEZOLID 600MG/300ML (2MG/ML) · SOLUTION · INTRAVENOUS
Approval history
2019-06-21Labeling · Supplement 1 · standardAP
2019-06-21Labeling · Supplement 2 · standardAP
2015-07-07UNKNOWN · Original · 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.