← FDA DRUG APPROVALS

FDA NDA · NDA020151

EFFEXOR

Sponsor: WYETH PHARMS INC

APPLICATION
NDA020151
TYPE
NDA
ORIGINAL APPROVAL
1993-12-28
LATEST ACTION
2012-12-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

EFFEXOR · ReferenceDiscontinued
VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
EFFEXOR · ReferenceDiscontinued
VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
EFFEXOR · ReferenceDiscontinued
VENLAFAXINE HYDROCHLORIDE EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
EFFEXOR · ReferenceDiscontinued
VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
EFFEXOR · ReferenceDiscontinued
VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
EFFEXOR · ReferenceDiscontinued
VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2012-12-12Labeling · Supplement 31 · standard — Letter ↗AP
2012-12-12Labeling · Supplement 58 · standard — Label ↗AP
2012-12-12Labeling · Supplement 60 · standard — Medication Guide ↗AP
2012-12-12Labeling · Supplement 55 · standard — Label ↗AP
2012-05-02Labeling · Supplement 59 · standard — Label ↗AP
2010-01-06Labeling · Supplement 56 · standard — Letter ↗AP
2010-01-06Labeling · Supplement 57 · standard — Label ↗AP
2009-11-09Labeling · Supplement 53 · standard — Letter ↗AP
2009-01-30Labeling · Supplement 54 · standard — Label ↗AP
2008-05-23Labeling · Supplement 51 · standard — Letter ↗AP
2008-02-11Labeling · Supplement 52 · standard — Letter ↗AP
2008-02-07Labeling · Supplement 50 · standardAP
2008-01-30Labeling · Supplement 41 · standard — Letter ↗AP
2007-09-20Labeling · Supplement 49 · standard — Letter ↗AP
2007-09-20Labeling · Supplement 47 · standard — Letter ↗AP
2007-08-01Labeling · Supplement 46 · standard — Letter ↗AP
2007-08-01Labeling · Supplement 33 · standard — Label ↗AP
2007-02-07Labeling · Supplement 43 · standard — Letter ↗AP
2006-10-20Labeling · Supplement 45 · standard — Letter ↗AP
2006-09-14Labeling · Supplement 44 · standard — Letter ↗AP
2006-02-24Labeling · Supplement 34 · standard — Letter ↗AP
2006-01-12Labeling · Supplement 38 · standard — Letter ↗AP
2006-01-12Labeling · Supplement 39 · standard — Letter ↗AP
2005-02-18Labeling · Supplement 35 · standard — Letter ↗AP
2004-05-13Labeling · Supplement 28 · standard — Review ↗AP
2004-05-13Labeling · Supplement 32 · standard — Label ↗AP
2004-05-13Labeling · Supplement 30 · standard — Label ↗AP
2004-05-05Efficacy · Supplement 24 · standard — Pediatric Medical Review ↗AP
2004-04-08Labeling · Supplement 29 · standard — Letter ↗AP
2004-03-19Labeling · Supplement 27 · standard — Letter ↗AP
2003-01-31Supplement · Supplement 23 · standard — Review ↗AP
2003-01-31Supplement · Supplement 21 · standard — Review ↗AP
2003-01-31Supplement · Supplement 16 · standard — Review ↗AP
2003-01-31Supplement · Supplement 22 · standard — Review ↗AP
2003-01-31Supplement · Supplement 20 · standard — Review ↗AP
2003-01-31Supplement · Supplement 19 · standard — Review ↗AP
2003-01-31Supplement · Supplement 25 · standard — Review ↗AP
2001-05-02Efficacy · Supplement 17 · standard — Label ↗AP
2001-05-02Efficacy · Supplement 18 · standard — Review ↗AP
2000-07-20Labeling · Supplement 15 · standardAP
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 →