← FDA DRUG APPROVALS

FDA NDA · NDA020699

EFFEXOR XR

venlafaxine hydrochloride

Sponsor: UPJOHN

APPLICATION
NDA020699
TYPE
NDA
ORIGINAL APPROVAL
1997-10-20
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription, Discontinued

Products

EFFEXOR XR · ReferencePrescription
VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
EFFEXOR XR · ReferencePrescription
VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
EFFEXOR XR · ReferenceDiscontinued
VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
EFFEXOR XR · ReferencePrescription
VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2023-08-18Labeling · Supplement 118 · standard — Label ↗AP
2022-08-15Labeling · Supplement 112 · standard — Letter ↗AP
2021-11-10Labeling · Supplement 113 · standard — Letter ↗AP
2021-09-20Labeling · Supplement 114 · 901 required — Letter ↗AP
2017-12-19Labeling · Supplement 110 · standard — Label ↗AP
2017-12-19Labeling · Supplement 111 · 901 required — Label ↗AP
2017-03-29Labeling · Supplement 108 · standard — Label ↗AP
2017-01-04Labeling · Supplement 107 · 901 order — Label ↗AP
2016-02-29Labeling · Supplement 106 · standard — Label ↗AP
2014-12-17Labeling · Supplement 91 · standard — Label ↗AP
2014-10-21Labeling · Supplement 104 · standard — Letter ↗AP
2014-07-07Labeling · Supplement 105 · 901 required — Letter ↗AP
2014-07-07Labeling · Supplement 103 · standard — Label ↗AP
2012-12-18Labeling · Supplement 102 · standard — Label ↗AP
2012-12-18Labeling · Supplement 99 · unknown — Label ↗AP
2012-08-24Labeling · Supplement 89 · standard — Label ↗AP
2012-08-24Labeling · Supplement 49 · standard — Label ↗AP
2012-05-03Labeling · Supplement 100 · standard — Label ↗AP
2010-01-06Labeling · Supplement 90 · standard — Letter ↗AP
2009-11-09Labeling · Supplement 86 · standard — Letter ↗AP
2009-01-30Labeling · Supplement 87 · standard — Letter ↗AP
2008-05-23Labeling · Supplement 81 · standard — Label ↗AP
2008-02-11Labeling · Supplement 83 · standard — Label ↗AP
2008-02-07Labeling · Supplement 80 · standardAP
2008-01-30Labeling · Supplement 67 · standard — Letter ↗AP
2007-12-14Efficacy · Supplement 47 · unknown — Label ↗AP
2007-09-20Labeling · Supplement 79 · standard — Letter ↗AP
2007-09-20Labeling · Supplement 77 · standard — Letter ↗AP
2007-08-01Labeling · Supplement 75 · standard — Letter ↗AP
2007-08-01Labeling · Supplement 55 · standard — Label ↗AP
2007-02-07Labeling · Supplement 69 · standard — Label ↗AP
2006-10-20Labeling · Supplement 72 · standard — Label ↗AP
2006-09-14Labeling · Supplement 71 · standard — Letter ↗AP
2006-03-02Manufacturing (CMC) · Supplement 66 — Letter ↗AP
2006-02-24Labeling · Supplement 56 · standard — Letter ↗AP
2006-01-12Labeling · Supplement 64 · standard — Letter ↗AP
2006-01-12Labeling · Supplement 62 · standard — Letter ↗AP
2005-12-01Efficacy · Supplement 59 · standard — Label ↗AP
2005-11-18Efficacy · Supplement 54 · standard — Letter ↗AP
2005-11-18Efficacy · Supplement 57 · standard — Label ↗AP
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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.

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