APPLICATION
ANDA089441
TYPE
ANDA
ORIGINAL APPROVAL
1986-12-18
LATEST ACTION
1999-10-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
EXTENDED PHENYTOIN SODIUMDiscontinued
PHENYTOIN SODIUM 100MG EXTENDED · CAPSULE · ORAL
Approval history
1999-10-19Labeling · Supplement 5AP
1999-02-03Labeling · Supplement 3AP
1994-05-11Manufacturing (CMC) · Supplement 2AP
1987-09-28Manufacturing (CMC) · Supplement 1AP
1986-12-18OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.