APPLICATION
ANDA085435
TYPE
ANDA
ORIGINAL APPROVAL
1977-04-15
LATEST ACTION
1982-11-02
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
PHENYTOIN SODIUMDiscontinued
PHENYTOIN SODIUM 100MG PROMPT · CAPSULE · ORAL
Approval history
1982-11-02Manufacturing (CMC) · Supplement 33AP
1977-04-15OriginalAP
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.