APPLICATION
ANDA089744
TYPE
ANDA
ORIGINAL APPROVAL
1987-12-18
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 16AP
2001-02-14Manufacturing (CMC) · Supplement 8AP
1998-03-25Labeling · Supplement 7AP
1995-12-22Manufacturing (CMC) · Supplement 6AP
1993-10-08Manufacturing (CMC) · Supplement 5AP
1991-10-28Labeling · Supplement 3AP
1990-03-01Manufacturing (CMC) · Supplement 2AP
1989-07-06Manufacturing (CMC) · Supplement 1AP
1987-12-18OriginalAP
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.