← FDA DRUG APPROVALS

FDA ANDA · ANDA040621

EXTENDED PHENYTOIN SODIUM

Sponsor: SUN PHARM INDS (IN)

APPLICATION
ANDA040621
TYPE
ANDA
ORIGINAL APPROVAL
2006-12-11
LATEST ACTION
2014-01-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

EXTENDED PHENYTOIN SODIUMDiscontinued
PHENYTOIN SODIUM 100MG EXTENDED · CAPSULE · ORAL

Approval history

2014-01-21Labeling · Supplement 8 · standardAP
2010-01-21Labeling · Supplement 7AP
2006-12-11Original — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →