APPLICATION
ANDA040781
TYPE
ANDA
ORIGINAL APPROVAL
2007-12-04
LATEST ACTION
2021-02-16
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PHENYTOIN SODIUMDiscontinued
PHENYTOIN SODIUM 50MG/ML · INJECTABLE · INJECTION
Approval history
2021-02-16Labeling · Supplement 7 · standardAP
2021-01-22Labeling · Supplement 6 · standardAP
2015-10-05Labeling · Supplement 4 · standardAP
2015-10-05Labeling · Supplement 2 · standardAP
2015-10-05Labeling · Supplement 5 · standardAP
2007-12-04OriginalAP
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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