APPLICATION
ANDA205517
TYPE
ANDA
ORIGINAL APPROVAL
2015-12-21
LATEST ACTION
2025-01-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LINEZOLIDPrescription
LINEZOLID 600MG · TABLET · ORAL
Approval history
2025-01-16Labeling · Supplement 14 · standardAP
2024-04-05Labeling · Supplement 13 · standardAP
2024-04-05Labeling · Supplement 9 · standardAP
2024-04-05Labeling · Supplement 7 · standardAP
2022-02-23Labeling · Supplement 4 · standardAP
2018-12-31Labeling · 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.
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