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FDA Drug Application 019839 by PFIZER

Application Number019839
Application Type New Drug Application
Sponsor ApplicantPFIZER
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
AP012/30/1991N12374000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm053351.htm 7/29/2005
AP012/30/1991N24206000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089832.pdf 12/4/2009
AP06/22/1992SCM       
AP010/25/1996SE1       
AP09/14/1995SLR       
AP09/7/1994SCF       
AP06/16/1995SLR       
AP03/22/1995SCS       
AP06/16/1995SLR       
AP010/5/1995SCM       
AP03/6/1996SCS       
AP07/8/1997SE14363011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019839_s011ap.pdf 7/8/1997
AP03/5/1996SCM       
AP010/10/1997SE54364017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019839ap.pdf 10/10/1997
AP010/10/1997SLR4365018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019839ap.pdf 10/10/1997
AP04/7/1997SCS       
AP012/4/1997SCS       
AP04/10/1998SCS       
AP012/7/1999SE15208026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19-839S026_Zoloft_Approv.pdf 12/7/1999
AP012/7/1999SE15209026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19-839S026_Zoloft_prntlbl.pdf 12/7/1999
AP012/7/1999SE12171026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19-839S026_Zoloft.cfm 12/7/1999
AP02/22/2001SLR       
AP010/7/1999SCM       
AP010/7/1999SCM       
AP01/3/2000SCP       
AP03/17/2000SCM       
AP010/12/2001SE85489033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20990s1lbl.pdf 4/25/2003
AP010/12/2001SE86294033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19839s33ltr.pdf 7/31/2003
AP09/20/2002SE8       
AP08/6/2001SE82164035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19839s35ltr.pdf 8/17/2001
AP08/6/2001SE82165035   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-839S035_Zoloft_Prntlbl.pdf 8/17/2001
AP08/6/2001SE82166035   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-839S35_Zoloft.cfm 8/17/2001
AP09/20/2002SE82160036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20990Se802,04,19839SE8-034,036LTR.pdf 9/20/2002
AP02/22/2001SLR       
AP011/16/2000SLR       
AP05/16/2002SE12155039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19-839s039ltr.pdf 5/16/2002
AP05/16/2002SE12156039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19839s39lbl.pdf 5/16/2002
AP07/12/2001SCM       
AP01/9/2002SCM       
AP09/18/2002SLR2153043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19839slr043,20990slr009ltr.pdf 9/18/2002
AP09/16/2003SE56670044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19839se5-se5-044,20990se5-010ltr.pdf 9/25/2003
AP09/16/2003SE56680044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19839se5-se5-044,20990se5-010_zoloft_lbl.pdf 9/25/2003
AP09/16/2003SE515925044   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019839s044,020990s010_ZoloftTOC.cfm 3/2/2007
AP02/7/2003SE19664045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19839se1-045,20990se1-011ltr.pdf 7/1/2004
AP02/7/2003SE14137045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020990s011lbl.pdf 3/5/2003
AP08/19/2004SE810056047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19839s047,050,20990s013,017ltr.pdf 8/25/2004
AP08/19/2004SE810068047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19839s047,050,20990s013,017lbl.pdf 8/25/2004
AP08/19/2004SLR10069050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19839s047,050,20990s013,017lbl.pdf 8/25/2004
AP08/19/2004SLR10057050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19839s047,050,20990s013,017ltr.pdf 8/25/2004
AP02/18/2005SLR11154053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19839s053,054,20990s019,020ltr.pdf 2/23/2005
AP02/18/2005SLR11982053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019839s053S054lbl.pdf 7/14/2005
AP02/18/2005SLR11983054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019839s053S054lbl.pdf 7/14/2005
AP02/18/2005SLR11155054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19839s053,054,20990s019,020ltr.pdf 2/23/2005
AP07/26/2005SLR12351055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019839s055,020990s022ltr.pdf 7/29/2005
AP05/4/2006SLR14115057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019839s057, 020990s023ltr.pdf 5/16/2006
AP09/14/2006SLR14819058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019839s058s060,020990s024s026lbl.pdf 9/15/2006
AP09/14/2006SLR14828058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019839s058, 019839s060, 020990s024, 020990s026ltr.pdf 9/15/2006
AP08/2/2007SLR17573059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/01190516s2316798s5417516s2320990s252719839s596364ltr.pdf 8/7/2007
AP09/14/2006SLR14820060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019839s058s060,020990s024s026lbl.pdf 9/15/2006
AP09/14/2006SLR14829060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019839s058, 019839s060, 020990s024, 020990s026ltr.pdf 9/15/2006
AP08/2/2007SLR17485063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019839s063s064,020990s027lbl.pdf 8/3/2007
AP08/2/2007SLR17574063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/01190516s2316798s5417516s2320990s252719839s596364ltr.pdf 8/7/2007
AP08/2/2007SLR17575064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/01190516s2316798s5417516s2320990s252719839s596364ltr.pdf 8/7/2007
AP08/2/2007SLR17486064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019839s063s064,020990s027lbl.pdf 8/3/2007
AP010/4/2007SLR18204065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019839s065, 020990s029ltr.pdf 10/10/2007
AP010/4/2007SLR18226065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019839s065,020990s029lbl.pdf 10/10/2007
AP03/6/2008SLR19386068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019839s068, 20990s031ltr.pdf 3/7/2008
AP03/6/2008SLR19400068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019839s068,020990s031lbl.pdf 3/7/2008
AP01/30/2009SLR21735070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019839s070,020990s032ltr.pdf 2/3/2009
AP01/30/2009SLR21755070   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019839s070,020990s032lbl.pdf 2/4/2009
AP08/19/2011SLR29855072   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf 8/24/2011
AP08/19/2011SLR29834072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019839s072,s075,s076,020990s033,s036,s037ltr.pdf 8/22/2011
AP012/18/2012SLR34723073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019839Orig1s073,s081,020990Orig1s034,s040ltr.pdf 12/21/2012
AP012/18/2012SLR34781073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/19839s073,s081,20990s034s040lbl.pdf 12/28/2012
AP08/19/2011SLR29856075   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf 8/24/2011
AP08/19/2011SLR29835075   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019839s072,s075,s076,020990s033,s036,s037ltr.pdf 8/22/2011
AP08/19/2011SLR29836076   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019839s072,s075,s076,020990s033,s036,s037ltr.pdf 8/22/2011
AP08/19/2011SLR29857076   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf 8/24/2011
AP02/1/2013SLR35066079   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019839Orig1s079,20990Orig1s038ltr.pdf 2/4/2013
AP02/1/2013SLR35087079   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019839s079,020990s038lbl.pdf 2/6/2013
AP07/3/2014SLR39788080   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019839Orig1s080,s083,020990Orig1s039,s041ltr.pdf 7/8/2014
AP07/3/2014SLR39803080   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s080s083,020990s039s041lbl.pdf 7/8/2014
AP012/18/2012SLR34782081   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/19839s073,s081,20990s034s040lbl.pdf 12/28/2012
AP012/18/2012SLR34724081   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019839Orig1s073,s081,020990Orig1s034,s040ltr.pdf 12/21/2012
AP09/26/2013SCM       
AP07/3/2014SLR39804083   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s080s083,020990s039s041lbl.pdf 7/8/2014
AP07/3/2014SLR39789083   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019839Orig1s080,s083,020990Orig1s039,s041ltr.pdf 7/8/2014
AP09/12/2014SLR40498084   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/19839Orig1s084,020990Orig1s043ltr.pdf 9/16/2014
AP09/12/2014SLR40519084   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s084,020990s043lbl.pdf 9/19/2014
AP01/10/2014SCM       




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