APPLICATION
ANDA078845
TYPE
ANDA
ORIGINAL APPROVAL
2015-12-21
LATEST ACTION
2025-02-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LINEZOLIDPrescription
LINEZOLID 600MG · TABLET · ORAL
Approval history
2025-02-14Labeling · Supplement 7 · standardAP
2025-02-14Labeling · Supplement 5 · standardAP
2025-02-14Labeling · Supplement 4 · standardAP
2019-02-12Labeling · Supplement 1 · standardAP
2019-02-12Labeling · Supplement 2 · standardAP
2015-12-21OriginalAP
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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