← FDA DRUG APPROVALS

FDA ANDA · ANDA040415

WARFARIN SODIUM

Sponsor: AUROBINDO PHARMA USA

APPLICATION
ANDA040415
TYPE
ANDA
ORIGINAL APPROVAL
2004-09-27
LATEST ACTION
2012-02-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

WARFARIN SODIUMDiscontinued
WARFARIN SODIUM 7.5MG · TABLET · ORAL
WARFARIN SODIUMDiscontinued
WARFARIN SODIUM 5MG · TABLET · ORAL
WARFARIN SODIUMDiscontinued
WARFARIN SODIUM 3MG · TABLET · ORAL
WARFARIN SODIUMDiscontinued
WARFARIN SODIUM 2MG · TABLET · ORAL
WARFARIN SODIUMDiscontinued
WARFARIN SODIUM 10MG · TABLET · ORAL
WARFARIN SODIUMDiscontinued
WARFARIN SODIUM 6MG · TABLET · ORAL
WARFARIN SODIUMDiscontinued
WARFARIN SODIUM 4MG · TABLET · ORAL
WARFARIN SODIUMDiscontinued
WARFARIN SODIUM 2.5MG · TABLET · ORAL
WARFARIN SODIUMDiscontinued
WARFARIN SODIUM 1MG · TABLET · ORAL

Approval history

2012-02-28Labeling · Supplement 13AP
2011-11-22Labeling · Supplement 11AP
2011-02-08Labeling · Supplement 10AP
2010-08-04Labeling · Supplement 9 · 901 orderAP
2009-11-16Labeling · Supplement 8AP
2009-01-22Labeling · Supplement 6AP
2007-01-09Labeling · Supplement 3 — Label ↗AP
2004-09-27OriginalAP
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 →