APPLICATION
ANDA040731
TYPE
ANDA
ORIGINAL APPROVAL
2008-06-30
LATEST ACTION
2023-03-28
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
EXTENDED PHENYTOIN SODIUMDiscontinued
PHENYTOIN SODIUM 300MG EXTENDED · CAPSULE · ORAL
EXTENDED PHENYTOIN SODIUMDiscontinued
PHENYTOIN SODIUM 200MG EXTENDED · CAPSULE · ORAL
Approval history
2023-03-28Labeling · Supplement 24 · standardAP
2023-03-28Labeling · Supplement 20 · standardAP
2010-01-21Labeling · Supplement 2AP
2008-06-30OriginalAP
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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