APPLICATION
ANDA200068
TYPE
ANDA
ORIGINAL APPROVAL
2015-06-03
LATEST ACTION
2024-08-22
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription
Products
LINEZOLIDPrescription
LINEZOLID 100MG/5ML · FOR SUSPENSION · ORAL
Approval history
2024-08-22Labeling · Supplement 10 · standardAP
2024-08-22Labeling · Supplement 9 · standardAP
2023-05-08Labeling · Supplement 8 · standardAP
2023-05-08Labeling · Supplement 7 · standardAP
2020-09-08Labeling · Supplement 6 · standardAP
2020-09-08Labeling · Supplement 2 · standardAP
2020-09-08Labeling · Supplement 3 · 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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