APPLICATION
ANDA089003
TYPE
ANDA
ORIGINAL APPROVAL
1985-05-31
LATEST ACTION
1995-03-08
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PHENYTOIN SODIUMDiscontinued
PHENYTOIN SODIUM 50MG/ML · INJECTABLE · INJECTION
Approval history
1995-03-08Manufacturing (CMC) · Supplement 7AP
1995-01-26Manufacturing (CMC) · Supplement 4AP
1993-01-14Labeling · Supplement 6AP
1991-08-20Labeling · Supplement 5AP
1991-02-04Labeling · Supplement 2AP
1985-05-31OriginalAP
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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