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FDA Drug Application 020151 by WYETH PHARMS INC

Application Number020151
Application Type New Drug Application
Sponsor ApplicantWYETH PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/28/1993N11414000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106481.htm 4/15/2005
AP012/28/1993N23953000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088586.pdf 11/18/2009
AP011/16/1994SCS       
AP011/28/1994SLR       
AP011/16/1994SCS       
AP06/25/1996SLR       
AP012/9/1998SLR       
AP012/9/1998SLR       
AP012/9/1998SLR       
AP012/9/1998SLR       
AP07/20/2000SLR       
AP010/4/1999SCS       
AP07/20/2000SLR       
AP03/3/2000SLR       
AP07/20/2000SLR       
AP01/31/2003S16956016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm 7/5/2007
AP05/2/2001SE15453017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20151s17s18lbl.pdf 4/24/2003
AP05/2/2001SE16218017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20699S15ltr.pdf 7/30/2003
AP05/2/2001SE116973017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020151s017s018,020699s015s016EffexorTOC.cfm 7/6/2007
AP05/2/2001SE16219018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20699S15ltr.pdf 7/30/2003
AP05/2/2001SE18938018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20699s15lbl.pdf 6/2/2004
AP05/2/2001SE116974018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020151s017s018,020699s015s016EffexorTOC.cfm 7/6/2007
AP01/31/2003S16957019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm 7/5/2007
AP01/31/2003S16958020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm 7/5/2007
AP01/31/2003S16959021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm 7/5/2007
AP01/31/2003S16960022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm 7/5/2007
AP01/31/2003S16961023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm 7/5/2007
AP05/5/2004SE58548024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151se5-024,20699se5-030ltr.pdf 5/7/2004
AP01/31/2003S16955025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm 7/5/2007
AP03/19/2004SLR8018027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr027,20699slr039,050ltr.pdf 3/24/2004
AP05/13/2004SLR8660028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr028,030,032,20699slr041,048,052ltr.pdf 5/26/2004
AP05/13/2004SLR8693028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf 5/27/2004
AP05/13/2004SLR18559028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020151_S028_EFFEXOR_TABLETS.pdf 11/19/2007
AP04/8/2004SLR8374029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr029,20699slr046ltr.pdf 4/20/2004
AP05/13/2004SLR8661030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr028,030,032,20699slr041,048,052ltr.pdf 5/26/2004
AP05/13/2004SLR8694030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf 5/27/2004
AP05/13/2004SLR18558030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020151_S030_EFFEXOR_TABLETS.pdf 11/19/2007
AP012/12/2012SLR34624031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf 12/13/2012
AP012/12/2012SLR34698031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020151Orig1s031,s055,s058,s060ltr.pdf 12/19/2012
AP05/13/2004SLR8662032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr028,030,032,20699slr041,048,052ltr.pdf 5/26/2004
AP05/13/2004SLR8695032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf 5/27/2004
AP05/13/2004SLR18557032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020151_S032_EFFEXOR_TABLETS.pdf 11/19/2007
AP08/1/2007SLR17448033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s033,020699s055lbl.pdf 8/2/2007
AP02/24/2006SLR13678034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s034,020699s056ltr.pdf 3/1/2006
AP02/18/2005SLR11151035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20151s035,20699s058ltr.pdf 2/23/2005
AP01/12/2006SLR13454038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s038s039_020699s062s064ltr.pdf 1/20/2006
AP01/12/2006SLR13455039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s038s039_020699s062s064ltr.pdf 1/20/2006
AP01/30/2008SLR19055041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020151s041ltr.pdf 2/5/2008
AP02/7/2007SLR15823043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s043, 020699s069ltr.pdf 2/12/2007
AP02/7/2007SLR15860043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s043,020699s069lbl.pdf 2/21/2007
AP09/14/2006SLR14816044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020151s044,020699s071lbl.pdf 9/15/2006
AP09/14/2006SLR14915044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s044, 020699s071ltr.pdf 9/20/2006
AP010/20/2006SLR15142045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020151s045,020699s072lbl.pdf 10/23/2006
AP010/20/2006SLR15161045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s045, 020699s072ltr.pdf 10/23/2006
AP08/1/2007SLR17447046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s046,020699s075lbl.pdf 8/2/2007
AP08/1/2007SLR17463046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s046, 020699s075LTR.pdf 8/2/2007
AP09/20/2007SLR17954047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s047,s49,020699s77,s79ltr.pdf 9/25/2007
AP09/20/2007SLR18015047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s047s049,020699s077s079lbl.pdf 9/26/2007
AP09/20/2007SLR17955049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s047,s49,020699s77,s79ltr.pdf 9/25/2007
AP09/20/2007SLR18016049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s047s049,020699s077s079lbl.pdf 9/26/2007
AP02/7/2008SLR       
AP05/23/2008SLR19881051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020699s081, 020151s051ltr.pdf 5/28/2008
AP05/23/2008SLR21250051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020151s051lbl.pdf 11/20/2008
AP02/11/2008SLR19098052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020151s052ltr.pdf 2/14/2008
AP02/11/2008SLR19106052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020151s052,020699s083lbl.pdf 2/14/2008
AP011/9/2009SLR23872053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020151s053lbl.pdf 11/13/2009
AP011/9/2009SLR24531053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020151s053,020699s086ltr.pdf 1/19/2010
AP01/30/2009SLR21729054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020699s087,020151s054ltr.pdf 2/3/2009
AP01/30/2009SLR21758054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020151s054lbl.pdf 2/4/2009
AP012/12/2012SLR34625055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf 12/13/2012
AP012/12/2012SLR34699055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020151Orig1s031,s055,s058,s060ltr.pdf 12/19/2012
AP01/6/2010SLR24475056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020151s056s057lbl.pdf 1/8/2010
AP01/6/2010SLR24510056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020151s056,s057,020699s090ltr.pdf 1/14/2010
AP01/6/2010SLR24476057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020151s056s057lbl.pdf 1/8/2010
AP01/6/2010SLR24511057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020151s056,s057,020699s090ltr.pdf 1/14/2010
AP012/12/2012SLR34626058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf 12/13/2012
AP012/12/2012SLR34700058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020151Orig1s031,s055,s058,s060ltr.pdf 12/19/2012
AP05/2/2012SLR32645059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s059lbl.pdf 5/7/2012
AP05/2/2012SLR32646059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s059,020699s100mg.pdf 5/7/2012
AP05/2/2012SLR32661059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020151s059,020699s100ltr.pdf 5/9/2012
AP012/12/2012SLR34627060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf 12/13/2012
AP012/12/2012SLR34701060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020151Orig1s031,s055,s058,s060ltr.pdf 12/19/2012




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