APPLICATION
ANDA206917
TYPE
ANDA
ORIGINAL APPROVAL
2016-08-04
LATEST ACTION
2025-03-13
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LINEZOLIDPrescription
LINEZOLID 600MG/300ML (2MG/ML) · SOLUTION · INTRAVENOUS
Approval history
2025-03-13Labeling · Supplement 9 · standardAP
2023-10-19Labeling · Supplement 4 · standardAP
2023-10-19Labeling · Supplement 2 · standardAP
2023-10-19Labeling · Supplement 7 · standardAP
2023-10-19Labeling · Supplement 3 · standardAP
2019-06-27Labeling · Supplement 1 · standardAP
2016-08-04UNKNOWN · 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.
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