APPLICATION
ANDA207001
TYPE
ANDA
ORIGINAL APPROVAL
2017-07-07
LATEST ACTION
2025-05-22
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LINEZOLIDPrescription
LINEZOLID 200MG/100ML (2MG/ML) · SOLUTION · INTRAVENOUS
LINEZOLIDPrescription
LINEZOLID 600MG/300ML (2MG/ML) · SOLUTION · INTRAVENOUS
Approval history
2025-05-22Labeling · Supplement 10 · standardAP
2024-01-10Labeling · Supplement 5 · standardAP
2024-01-10Labeling · Supplement 8 · standardAP
2024-01-10Labeling · Supplement 6 · standardAP
2024-01-10Labeling · Supplement 4 · standardAP
2024-01-10Labeling · Supplement 2 · standardAP
2017-07-07UNKNOWN · 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.
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