Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020699
Company: WYETH PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EFFEXOR XR VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
EFFEXOR XR VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
EFFEXOR XR VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
EFFEXOR XR VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/20/1997 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020699_effexorxr_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/19/2017 SUPPL-111 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s110s111lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020699Orig1s110s111ltr.pdf
12/19/2017 SUPPL-110 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s110s111lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020699Orig1s110s111ltr.pdf
03/29/2017 SUPPL-108 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s108lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020699Orig1s108ltr.pdf
01/04/2017 SUPPL-107 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s107lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021992Orig1s044,020699Orig1s107ltr.pdf
02/29/2016 SUPPL-106 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020699s106lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020699Orig1s106ltr.pdf
07/07/2014 SUPPL-105 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020699s103s105lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020699Orig1s103,s105ltr.pdf
10/21/2014 SUPPL-104 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020699Orig1s104ltr.pdf
07/07/2014 SUPPL-103 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020699s103s105lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020699Orig1s103,s105ltr.pdf
12/18/2012 SUPPL-102 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s099,s102lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020699Orig1s099,s102ltr.pdf
05/03/2012 SUPPL-100 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s059,020699s100lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020151s059,020699s100ltr.pdf
12/18/2012 SUPPL-99 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s099,s102lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020699Orig1s099,s102ltr.pdf
12/17/2014 SUPPL-91 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020699s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020699Orig1s091ltr.pdf
01/06/2010 SUPPL-90 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020699s090lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020151s056,s057,020699s090ltr.pdf
08/24/2012 SUPPL-89 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s049-89.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020699Orig1s049,s089ltr.pdf
01/30/2009 SUPPL-87 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020699s087lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020699s087,020151s054ltr.pdf
11/09/2009 SUPPL-86 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020699s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020151s053,020699s086ltr.pdf
02/11/2008 SUPPL-83 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020151s052,020699s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020699s083ltr.pdf
05/23/2008 SUPPL-81 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020699s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020699s081, 020151s051ltr.pdf
02/07/2008 SUPPL-80 Labeling

Label is not available on this site.

09/20/2007 SUPPL-79 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s047s049,020699s077s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s047,s49,020699s77,s79ltr.pdf
09/20/2007 SUPPL-77 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s047s049,020699s077s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s047,s49,020699s77,s79ltr.pdf
08/01/2007 SUPPL-75 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s046,020699s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s046, 020699s075LTR.pdf
10/20/2006 SUPPL-72 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020151s045,020699s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s045, 020699s072ltr.pdf
09/14/2006 SUPPL-71 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020151s044,020699s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s044, 020699s071ltr.pdf
02/07/2007 SUPPL-69 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s043,020699s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s043, 020699s069ltr.pdf
01/30/2008 SUPPL-67 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020699s067ltr.pdf
03/02/2006 SUPPL-66 Labeling-Package Insert, Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020699s066ltr.pdf
01/12/2006 SUPPL-64 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s038s039_020699s062s064ltr.pdf
01/12/2006 SUPPL-62 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s038s039_020699s062s064ltr.pdf
12/01/2005 SUPPL-59 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020699s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020699s059ltr.pdf
02/18/2005 SUPPL-58 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20151s035,20699s058ltr.pdf
11/18/2005 SUPPL-57 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020699s054,057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020699s054,057ltr.pdf
02/24/2006 SUPPL-56 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s034,020699s056ltr.pdf
08/01/2007 SUPPL-55 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s033,020699s055lbl.pdf
11/18/2005 SUPPL-54 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020699s054,057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020699s054,057ltr.pdf
05/13/2004 SUPPL-52 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr028,030,032,20699slr041,048,052ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020699_S052_EFFEXOR_TABLETS.pdf
03/19/2004 SUPPL-50 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr027,20699slr039,050ltr.pdf
08/24/2012 SUPPL-49 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s049-89.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020699Orig1s049,s089ltr.pdf
05/13/2004 SUPPL-48 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr028,030,032,20699slr041,048,052ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020699_S048_EFFEXOR_TABLETS.pdf
12/14/2007 SUPPL-47 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020699s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020699s047ltr.pdf
04/08/2004 SUPPL-46 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr029,20699slr046ltr.pdf
03/16/2004 SUPPL-45 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20699slr045ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020699_s045_EFFEXOR_XR_EXTENDED_RELEASE_CAPS.pdf
09/02/2003 SUPPL-43 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20699slr038,043ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020699_S043_EFFEXOR_AP.pdf
05/13/2004 SUPPL-41 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr028,030,032,20699slr041,048,052ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020699_S041_EFFEXOR_TABLETS.pdf
03/19/2004 SUPPL-39 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr027,20699slr039,050ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020699_s039_EFFEXOR XR_EXTENDED_RELEASE_CAPS.pdf
09/02/2003 SUPPL-38 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20699slr038,043ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020699_S038_EFFEXOR_AP.pdf
01/31/2003 SUPPL-34 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm
02/26/2003 SUPPL-32 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20699slr032ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020699_S032_EFFEXOR_AP.pdf
05/05/2004 SUPPL-30 Efficacy-New Patient Population Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151se5-024,20699se5-030ltr.pdf
10/22/2002 SUPPL-29 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20699slr029ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020699_S029_EFFEXOR_AP.pdf
11/19/2002 SUPPL-28 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020699_S028_EFFEXOR.pdf
01/31/2003 SUPPL-27 Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm
01/31/2003 SUPPL-26 Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm
08/07/2002 SUPPL-25 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020699_S025_EFFEXOR_XR.pdf
10/23/2001 SUPPL-24 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020699_s024_EFFEXOR XR_EXTENDED_RELEASE_CAPS.pdf
01/31/2003 SUPPL-23 Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm
02/11/2003 SUPPL-22 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020699s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20699se1-022ltr.pdf
01/31/2003 SUPPL-21 Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm
12/13/2000 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/31/2003 SUPPL-18 Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm
10/31/2000 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/02/2001 SUPPL-16 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20699s15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20699S15ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020151s017s018,020699s015s016EffexorTOC.cfm
05/02/2001 SUPPL-15 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20699s15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20699S15ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020151s017s018,020699s015s016EffexorTOC.cfm
01/31/2003 SUPPL-14 Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm
07/20/2000 SUPPL-13 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020699_s013_EFFEXOR_XR.pdf
06/12/2000 SUPPL-12 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020699_S012_EFFEXOR_XR.pdf
02/25/2000 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/09/2000 SUPPL-10 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020699_S010_EFFEXOR.pdf
03/09/2000 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/03/2000 SUPPL-8 Labeling

Label is not available on this site.

07/13/2000 SUPPL-7 Efficacy-Labeling Change With Clinical Data

Label is not available on this site.

12/21/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/22/2001 SUPPL-5 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020699_s005_EFFEXOR XR_EXTENDED_RELEASE_CAPS.pdf
05/08/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/11/1999 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20699s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20699s1ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/19/2017 SUPPL-111 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s110s111lbl.pdf
12/19/2017 SUPPL-110 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s110s111lbl.pdf
03/29/2017 SUPPL-108 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s108lbl.pdf
01/04/2017 SUPPL-107 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s107lbl.pdf
01/04/2017 SUPPL-107 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s107lbl.pdf
02/29/2016 SUPPL-106 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020699s106lbl.pdf
12/17/2014 SUPPL-91 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020699s091lbl.pdf
07/07/2014 SUPPL-105 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020699s103s105lbl.pdf
07/07/2014 SUPPL-103 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020699s103s105lbl.pdf
12/18/2012 SUPPL-102 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s099,s102lbl.pdf
12/18/2012 SUPPL-99 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s099,s102lbl.pdf
08/24/2012 SUPPL-89 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s049-89.pdf
08/24/2012 SUPPL-49 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s049-89.pdf
05/03/2012 SUPPL-100 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s059,020699s100lbl.pdf
01/06/2010 SUPPL-90 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020699s090lbl.pdf
11/09/2009 SUPPL-86 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020699s086lbl.pdf
01/30/2009 SUPPL-87 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020699s087lbl.pdf
05/23/2008 SUPPL-81 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020699s081lbl.pdf
02/11/2008 SUPPL-83 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020151s052,020699s083lbl.pdf
12/14/2007 SUPPL-47 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020699s047lbl.pdf
09/20/2007 SUPPL-79 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s047s049,020699s077s079lbl.pdf
09/20/2007 SUPPL-77 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s047s049,020699s077s079lbl.pdf
08/01/2007 SUPPL-75 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s046,020699s075lbl.pdf
08/01/2007 SUPPL-55 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s033,020699s055lbl.pdf
02/07/2007 SUPPL-69 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s043,020699s069lbl.pdf
10/20/2006 SUPPL-72 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020151s045,020699s072lbl.pdf
09/14/2006 SUPPL-71 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020151s044,020699s071lbl.pdf
12/01/2005 SUPPL-59 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020699s059lbl.pdf
11/18/2005 SUPPL-57 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020699s054,057lbl.pdf
11/18/2005 SUPPL-54 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020699s054,057lbl.pdf
05/13/2004 SUPPL-52 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf
05/13/2004 SUPPL-48 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf
05/13/2004 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf
02/11/2003 SUPPL-22 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020699s022lbl.pdf
05/02/2001 SUPPL-16 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20699s15lbl.pdf
05/02/2001 SUPPL-15 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20699s15lbl.pdf
03/11/1999 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20699s1lbl.pdf

EFFEXOR XR

CAPSULE, EXTENDED RELEASE;ORAL; EQ 37.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EFFEXOR XR VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 020699 WYETH PHARMS
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 212277 ANNORA PHARMA
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200834 AUROBINDO PHARMA LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078421 DR REDDYS LABS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 201272 INTELLIPHARMACEUTICS
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 204889 MACLEODS PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 091123 ORCHID HLTHCARE
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 076565 TEVA
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090899 TORRENT PHARMS LLC
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090071 VALEANT PHARMS NORTH
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078865 WOCKHARDT
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090174 ZYDUS PHARMS USA INC

CAPSULE, EXTENDED RELEASE;ORAL; EQ 75MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EFFEXOR XR VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 020699 WYETH PHARMS
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 212277 ANNORA PHARMA
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200834 AUROBINDO PHARMA LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078421 DR REDDYS LABS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 201272 INTELLIPHARMACEUTICS
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 204889 MACLEODS PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 091123 ORCHID HLTHCARE
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 076565 TEVA
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090899 TORRENT PHARMS LLC
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090071 VALEANT PHARMS NORTH
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078865 WOCKHARDT
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090174 ZYDUS PHARMS USA INC

CAPSULE, EXTENDED RELEASE;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EFFEXOR XR VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 020699 WYETH PHARMS
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 212277 ANNORA PHARMA
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200834 AUROBINDO PHARMA LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078421 DR REDDYS LABS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 201272 INTELLIPHARMACEUTICS
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 204889 MACLEODS PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 091123 ORCHID HLTHCARE
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 076565 TEVA
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090899 TORRENT PHARMS LLC
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090071 VALEANT PHARMS NORTH
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078865 WOCKHARDT
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090174 ZYDUS PHARMS USA INC

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English