APPLICATION
ANDA040573
TYPE
ANDA
ORIGINAL APPROVAL
2006-09-13
LATEST ACTION
2024-10-02
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PHENYTOIN SODIUMPrescription
PHENYTOIN SODIUM 50MG/ML · INJECTABLE · INJECTION
Approval history
2024-10-02Labeling · Supplement 15 · standardAP
2021-02-16Labeling · Supplement 13 · standardAP
2020-10-06Labeling · Supplement 12 · standardAP
2011-01-27Labeling · Supplement 9AP
2006-09-13OriginalAP
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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