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FDA Drug Application 020699 by WYETH PHARMS INC

Application Number020699
Application Type New Drug Application
Sponsor ApplicantWYETH PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/20/1997N11415000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106481.htm 4/15/2005
AP010/20/1997N24183000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM192697.pdf 12/3/2009
AP010/20/1997N24471000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020699_effexorxr_toc.cfm 1/7/2010
AP03/11/1999SE1780001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20699s1ltr.pdf 3/11/1999
AP03/11/1999SE1781001   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20699s1lbl.pdf 3/11/1999
AP05/8/1998SCM       
AP08/22/2001SCM20473005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020699_s005_EFFEXOR XR_EXTENDED_RELEASE_CAPS.pdf 8/4/2008
AP012/21/1999SCM       
AP07/13/2000SE8       
AP03/3/2000SLR       
AP03/9/2000SCM       
AP03/9/2000SCM17928010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020699_S010_EFFEXOR.pdf 9/24/2007
AP02/25/2000SCM       
AP06/12/2000SLR20479012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020699_S012_EFFEXOR_XR.pdf 8/4/2008
AP07/20/2000SCM20478013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020699_s013_EFFEXOR_XR.pdf 8/4/2008
AP01/31/2003S16966014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm 7/6/2007
AP05/2/2001SE116975015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020151s017s018,020699s015s016EffexorTOC.cfm 7/6/2007
AP05/2/2001SE15494015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20699s15lbl.pdf 4/28/2003
AP05/2/2001SE16214015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20699S15ltr.pdf 7/30/2003
AP05/2/2001SE16216016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20699S15ltr.pdf 7/30/2003
AP05/2/2001SE18937016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20699s15lbl.pdf 6/2/2004
AP05/2/2001SE116976016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020151s017s018,020699s015s016EffexorTOC.cfm 7/6/2007
AP010/31/2000SCM       
AP01/31/2003S16967018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm 7/6/2007
AP012/13/2000SCP       
AP01/31/2003S16968021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm 7/6/2007
AP02/11/2003SE18939022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20699se1-022ltr.pdf 6/2/2004
AP02/11/2003SE14138022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020699s022lbl.pdf 3/5/2003
AP01/31/2003S16969023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm 7/6/2007
AP010/23/2001SCS20461024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020699_s024_EFFEXOR XR_EXTENDED_RELEASE_CAPS.pdf 8/4/2008
AP08/7/2002SCM19200025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020699_S025_EFFEXOR_XR.pdf 2/19/2008
AP01/31/2003S16970026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm 7/6/2007
AP01/31/2003S16971027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm 7/6/2007
AP011/19/2002SCS19199028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020699_S028_EFFEXOR.pdf 2/19/2008
AP010/22/2002SLR16977029   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020699_S029_EFFEXOR_AP.pdf 7/6/2007
AP010/22/2002SLR1746029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20699slr029ltr.pdf 10/22/2002
AP05/5/2004SE58549030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151se5-024,20699se5-030ltr.pdf 5/7/2004
AP02/26/2003SLR4270032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20699slr032ltr.pdf 3/10/2003
AP02/26/2003SLR16219032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020699_S032_EFFEXOR_AP.pdf 4/11/2007
AP01/31/2003S16972034   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm 7/6/2007
AP09/2/2003SLR16978038   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020699_S038_EFFEXOR_AP.pdf 7/6/2007
AP09/2/2003SLR6614038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20699slr038,043ltr.pdf 9/9/2003
AP03/19/2004SLR8019039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr027,20699slr039,050ltr.pdf 3/24/2004
AP03/19/2004SLR20375039   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020699_s039_EFFEXOR XR_EXTENDED_RELEASE_CAPS.pdf 7/31/2008
AP05/13/2004SLR18528041   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020699_S041_EFFEXOR_TABLETS.pdf 11/19/2007
AP05/13/2004SLR8697041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf 5/27/2004
AP05/13/2004SLR8663041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr028,030,032,20699slr041,048,052ltr.pdf 5/26/2004
AP09/2/2003SLR6615043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20699slr038,043ltr.pdf 9/9/2003
AP09/2/2003SLR16979043   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020699_S043_EFFEXOR_AP.pdf 7/6/2007
AP03/16/2004SLR20374045   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020699_s045_EFFEXOR_XR_EXTENDED_RELEASE_CAPS.pdf 7/31/2008
AP03/16/2004SLR7992045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20699slr045ltr.pdf 3/19/2004
AP04/8/2004SLR8375046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr029,20699slr046ltr.pdf 4/20/2004
AP012/14/2007SE118690047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020699s047lbl.pdf 12/27/2007
AP012/14/2007SE118832047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020699s047ltr.pdf 1/9/2008
AP05/13/2004SLR18527048   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020699_S048_EFFEXOR_TABLETS.pdf 11/19/2007
AP05/13/2004SLR8664048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr028,030,032,20699slr041,048,052ltr.pdf 5/26/2004
AP05/13/2004SLR8698048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf 5/27/2004
AP08/24/2012SLR33695049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s049-89.pdf 9/11/2012
AP08/24/2012SLR33563049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020699Orig1s049,s089ltr.pdf 8/28/2012
AP08/24/2012SLR33575049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s049s089mg.pdf 8/28/2012
AP03/19/2004SLR8020050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr027,20699slr039,050ltr.pdf 3/24/2004
AP05/13/2004SLR8699052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf 5/27/2004
AP05/13/2004SLR8665052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr028,030,032,20699slr041,048,052ltr.pdf 5/26/2004
AP05/13/2004SLR18526052   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020699_S052_EFFEXOR_TABLETS.pdf 11/19/2007
AP011/18/2005SE113127054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020699s054,057lbl.pdf 11/22/2005
AP011/18/2005SE113131054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020699s054,057ltr.pdf 11/22/2005
AP08/1/2007SLR17446055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s033,020699s055lbl.pdf 8/2/2007
AP02/24/2006SLR13677056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s034,020699s056ltr.pdf 3/1/2006
AP011/18/2005SE113132057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020699s054,057ltr.pdf 11/22/2005
AP011/18/2005SE113128057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020699s054,057lbl.pdf 11/22/2005
AP02/18/2005SLR11152058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20151s035,20699s058ltr.pdf 2/23/2005
AP011/29/2005SE513199059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020699s059lbl.pdf 12/5/2005
AP011/29/2005SE513209059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020699s059ltr.pdf 12/5/2005
AP01/12/2006SLR13452062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s038s039_020699s062s064ltr.pdf 1/20/2006
AP01/12/2006SLR13453064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s038s039_020699s062s064ltr.pdf 1/20/2006
AP03/2/2006SCP13829066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020699s066ltr.pdf 3/23/2006
AP01/30/2008SLR19054067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020699s067ltr.pdf 2/5/2008
AP02/7/2007SLR15822069   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s043, 020699s069ltr.pdf 2/12/2007
AP02/7/2007SLR15859069   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s043,020699s069lbl.pdf 2/21/2007
AP09/14/2006SLR14815071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020151s044,020699s071lbl.pdf 9/15/2006
AP09/14/2006SLR14914071   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s044, 020699s071ltr.pdf 9/20/2006
AP010/20/2006SLR15141072   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020151s045,020699s072lbl.pdf 10/23/2006
AP010/20/2006SLR15160072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s045, 020699s072ltr.pdf 10/23/2006
AP08/1/2007SLR17462075   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s046, 020699s075LTR.pdf 8/2/2007
AP08/1/2007SLR17445075   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s046,020699s075lbl.pdf 8/2/2007
AP09/20/2007SLR17956077   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s047,s49,020699s77,s79ltr.pdf 9/25/2007
AP09/20/2007SLR18013077   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s047s049,020699s077s079lbl.pdf 9/26/2007
AP09/20/2007SLR18014079   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s047s049,020699s077s079lbl.pdf 9/26/2007
AP09/20/2007SLR17957079   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s047,s49,020699s77,s79ltr.pdf 9/25/2007
AP02/7/2008SLR       
AP05/23/2008SLR19880081   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020699s081, 020151s051ltr.pdf 5/28/2008
AP05/23/2008SLR21249081   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020699s081lbl.pdf 11/20/2008
AP02/11/2008SLR19100083   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020699s083ltr.pdf 2/14/2008
AP02/11/2008SLR19107083   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020151s052,020699s083lbl.pdf 2/14/2008
AP011/9/2009SLR24532086   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020151s053,020699s086ltr.pdf 1/19/2010
AP011/9/2009SLR23873086   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020699s086lbl.pdf 11/13/2009
AP01/30/2009SLR21730087   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020699s087,020151s054ltr.pdf 2/3/2009
AP01/30/2009SLR21761087   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020699s087lbl.pdf 2/4/2009
AP08/24/2012SLR33576089   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s049s089mg.pdf 8/28/2012
AP08/24/2012SLR33694089   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s049-89.pdf 9/11/2012
AP08/24/2012SLR33564089   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020699Orig1s049,s089ltr.pdf 8/28/2012
AP01/6/2010SLR24477090   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020699s090lbl.pdf 1/8/2010
AP01/6/2010SLR24512090   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020151s056,s057,020699s090ltr.pdf 1/14/2010
AP012/17/2014SLR41328091   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020699s091lbl.pdf 12/19/2014
AP012/17/2014SLR41335091   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020699Orig1s091ltr.pdf 12/19/2014
AP012/18/2012SLR34718099   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020699Orig1s099,s102ltr.pdf 12/21/2012
AP012/18/2012SLR34789099   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s099,s102lbl.pdf 12/28/2012
AP05/2/2012SLR32644100   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s059,020699s100lbl.pdf 5/7/2012
AP05/2/2012SLR32647100   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s059,020699s100mg.pdf 5/7/2012
AP05/2/2012SLR32662100   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020151s059,020699s100ltr.pdf 5/9/2012
AP012/18/2012SLR34790102   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s099,s102lbl.pdf 12/28/2012
AP012/18/2012SLR34719102   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020699Orig1s099,s102ltr.pdf 12/21/2012
AP07/7/2014SLR39816103   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020699Orig1s103,s105ltr.pdf 7/9/2014
AP07/7/2014SLR39796103   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020699s103s105lbl.pdf 7/8/2014
AP010/21/2014SLR40863104   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020699Orig1s104ltr.pdf 10/23/2014
AP010/21/2014SLR40869104   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020699s104lbl.pdf 10/24/2014
AP07/7/2014SLR39817105   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020699Orig1s103,s105ltr.pdf 7/9/2014
AP07/7/2014SLR39797105   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020699s103s105lbl.pdf 7/8/2014
AP02/29/2016SLR45307106   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020699Orig1s106ltr.pdf 3/2/2016
AP02/29/2016SLR45344106   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020699s106lbl.pdf 3/3/2016




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