Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020151
Company: WYETH PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EFFEXOR VENLAFAXINE HYDROCHLORIDE EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
EFFEXOR VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
EFFEXOR VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
EFFEXOR VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
EFFEXOR VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
EFFEXOR VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/28/1993 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/12/2012 SUPPL-60 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020151Orig1s031,s055,s058,s060ltr.pdf
05/02/2012 SUPPL-59 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020151s059,020699s100ltr.pdf
12/12/2012 SUPPL-58 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020151Orig1s031,s055,s058,s060ltr.pdf
01/06/2010 SUPPL-57 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020151s056s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020151s056,s057,020699s090ltr.pdf
01/06/2010 SUPPL-56 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020151s056s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020151s056,s057,020699s090ltr.pdf
12/12/2012 SUPPL-55 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020151Orig1s031,s055,s058,s060ltr.pdf
01/30/2009 SUPPL-54 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020151s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020699s087,020151s054ltr.pdf
11/09/2009 SUPPL-53 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020151s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020151s053,020699s086ltr.pdf
02/11/2008 SUPPL-52 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/2008/020151s052ltr.pdf
05/23/2008 SUPPL-51 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020151s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020699s081, 020151s051ltr.pdf
02/07/2008 SUPPL-50 Labeling

Label is not available on this site.

09/20/2007 SUPPL-49 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-47 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-46 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-45 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-44 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-43 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-41 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020151s041ltr.pdf
01/12/2006 SUPPL-39 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-38 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s038s039_020699s062s064ltr.pdf
02/18/2005 SUPPL-35 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20151s035,20699s058ltr.pdf
02/24/2006 SUPPL-34 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-33 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s033,020699s055lbl.pdf
05/13/2004 SUPPL-32 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/2004/020151_S032_EFFEXOR_TABLETS.pdf
12/12/2012 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020151Orig1s031,s055,s058,s060ltr.pdf
05/13/2004 SUPPL-30 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/2004/020151_S030_EFFEXOR_TABLETS.pdf
04/08/2004 SUPPL-29 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr029,20699slr046ltr.pdf
05/13/2004 SUPPL-28 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/2004/020151_S028_EFFEXOR_TABLETS.pdf
03/19/2004 SUPPL-27 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr027,20699slr039,050ltr.pdf
01/31/2003 SUPPL-25 Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm
05/05/2004 SUPPL-24 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
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
01/31/2003 SUPPL-22 Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm
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
01/31/2003 SUPPL-20 Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm
01/31/2003 SUPPL-19 Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm
05/02/2001 SUPPL-18 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-17 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20151s17s18lbl.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-16 Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm
07/20/2000 SUPPL-15 Labeling

Label is not available on this site.

03/03/2000 SUPPL-14 Labeling

Label is not available on this site.

07/20/2000 SUPPL-13 Labeling

Label is not available on this site.

10/04/1999 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

07/20/2000 SUPPL-11 Labeling

Label is not available on this site.

12/09/1998 SUPPL-9 Labeling

Label is not available on this site.

12/09/1998 SUPPL-8 Labeling

Label is not available on this site.

12/09/1998 SUPPL-7 Labeling

Label is not available on this site.

12/09/1998 SUPPL-6 Labeling

Label is not available on this site.

06/25/1996 SUPPL-5 Labeling

Label is not available on this site.

11/16/1994 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

11/28/1994 SUPPL-2 Labeling

Label is not available on this site.

11/16/1994 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/12/2012 SUPPL-60 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf
12/12/2012 SUPPL-58 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf
12/12/2012 SUPPL-55 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf
12/12/2012 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf
05/02/2012 SUPPL-59 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s059lbl.pdf
01/06/2010 SUPPL-57 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020151s056s057lbl.pdf
01/06/2010 SUPPL-56 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020151s056s057lbl.pdf
11/09/2009 SUPPL-53 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020151s053lbl.pdf
01/30/2009 SUPPL-54 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020151s054lbl.pdf
05/23/2008 SUPPL-51 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020151s051lbl.pdf
02/11/2008 SUPPL-52 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020151s052,020699s083lbl.pdf
09/20/2007 SUPPL-49 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s047s049,020699s077s079lbl.pdf
09/20/2007 SUPPL-47 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s047s049,020699s077s079lbl.pdf
08/01/2007 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s046,020699s075lbl.pdf
08/01/2007 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s033,020699s055lbl.pdf
02/07/2007 SUPPL-43 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s043,020699s069lbl.pdf
10/20/2006 SUPPL-45 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020151s045,020699s072lbl.pdf
09/14/2006 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020151s044,020699s071lbl.pdf
05/13/2004 SUPPL-32 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-30 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-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf
05/02/2001 SUPPL-18 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20699s15lbl.pdf
05/02/2001 SUPPL-17 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20151s17s18lbl.pdf

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