APPLICATION
ANDA089521
TYPE
ANDA
ORIGINAL APPROVAL
1987-03-17
LATEST ACTION
2014-01-29
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PHENYTOIN SODIUMDiscontinued
PHENYTOIN SODIUM 50MG/ML · INJECTABLE · INJECTION
Approval history
2014-01-29Labeling · Supplement 11AP
1995-11-30Manufacturing (CMC) · Supplement 3AP
1994-06-06Manufacturing (CMC) · Supplement 2AP
1991-11-12Labeling · Supplement 1AP
1987-03-17OriginalAP
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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