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FDA Drug Application 020990 by PFIZER

Application Number020990
Application Type New Drug Application
Sponsor ApplicantPFIZER
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
AP012/7/1999N856000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20990ltr.pdf 12/7/1999
AP012/7/1999N857000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20990lbl.pdf 12/7/1999
AP012/7/1999N2172000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20990_Zoloft.cfm 12/7/1999
AP012/7/1999N12375000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm053351.htm 7/29/2005
AP012/7/1999N24207000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089832.pdf 12/4/2009
AP010/12/2001SE85490001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20990s1lbl.pdf 4/25/2003
AP010/12/2001SE86295001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19839s33ltr.pdf 7/31/2003
AP09/20/2002SE86132002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20990Se802,04,19839SE8-034,036LTR.pdf 7/23/2003
AP08/6/2001SE82167003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19839s35ltr.pdf 8/17/2001
AP08/6/2001SE82168003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-839S035_Zoloft_Prntlbl.pdf 8/17/2001
AP08/6/2001SE82169003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-839S35_Zoloft.cfm 8/17/2001
AP09/20/2002SE82163004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20990Se802,04,19839SE8-034,036LTR.pdf 9/20/2002
AP02/22/2001SLR       
AP011/16/2000SLR       
AP05/16/2002SE12157007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19-839s039ltr.pdf 5/16/2002
AP05/16/2002SE12158007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19839s39lbl.pdf 5/16/2002
AP09/18/2002SLR2154009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19839slr043,20990slr009ltr.pdf 9/18/2002
AP09/16/2003SE56671010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19839se5-se5-044,20990se5-010ltr.pdf 9/25/2003
AP09/16/2003SE56681010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19839se5-se5-044,20990se5-010_zoloft_lbl.pdf 9/25/2003
AP09/16/2003SE515926010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019839s044,020990s010_ZoloftTOC.cfm 3/2/2007
AP02/7/2003SE19665011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19839se1-045,20990se1-011ltr.pdf 7/1/2004
AP02/7/2003SE14136011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020990s011lbl.pdf 3/5/2003
AP08/19/2004SE810058013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19839s047,050,20990s013,017ltr.pdf 8/25/2004
AP08/19/2004SE810070013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19839s047,050,20990s013,017lbl.pdf 8/25/2004
AP08/19/2004SLR10071017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19839s047,050,20990s013,017lbl.pdf 8/25/2004
AP08/19/2004SLR10059017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19839s047,050,20990s013,017ltr.pdf 8/25/2004
AP02/18/2005SLR11156019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19839s053,054,20990s019,020ltr.pdf 2/23/2005
AP02/18/2005SLR11984019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019839s053S054lbl.pdf 7/14/2005
AP02/18/2005SLR11985020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019839s053S054lbl.pdf 7/14/2005
AP02/18/2005SLR11157020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19839s053,054,20990s019,020ltr.pdf 2/23/2005
AP07/26/2005SLR12350022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019839s055,020990s022ltr.pdf 7/29/2005
AP05/4/2006SLR14114023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019839s057, 020990s023ltr.pdf 5/16/2006
AP09/14/2006SLR14817024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019839s058s060,020990s024s026lbl.pdf 9/15/2006
AP09/14/2006SLR14826024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019839s058, 019839s060, 020990s024, 020990s026ltr.pdf 9/15/2006
AP08/2/2007SLR17576025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/01190516s2316798s5417516s2320990s252719839s596364ltr.pdf 8/7/2007
AP09/14/2006SLR14818026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019839s058s060,020990s024s026lbl.pdf 9/15/2006
AP09/14/2006SLR14827026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019839s058, 019839s060, 020990s024, 020990s026ltr.pdf 9/15/2006
AP08/2/2007SLR17484027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019839s063s064,020990s027lbl.pdf 8/3/2007
AP08/2/2007SLR17577027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/01190516s2316798s5417516s2320990s252719839s596364ltr.pdf 8/7/2007
AP010/4/2007SLR18205029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019839s065, 020990s029ltr.pdf 10/10/2007
AP010/4/2007SLR18227029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019839s065,020990s029lbl.pdf 10/10/2007
AP03/6/2008SLR19387031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019839s068, 20990s031ltr.pdf 3/7/2008
AP03/6/2008SLR19399031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019839s068,020990s031lbl.pdf 3/7/2008
AP01/30/2009SLR21734032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019839s070,020990s032ltr.pdf 2/3/2009
AP01/30/2009SLR21754032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019839s070,020990s032lbl.pdf 2/4/2009
AP08/19/2011SLR29837033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019839s072,s075,s076,020990s033,s036,s037ltr.pdf 8/22/2011
AP08/19/2011SLR29852033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf 8/24/2011
AP012/18/2012SLR34725034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019839Orig1s073,s081,020990Orig1s034,s040ltr.pdf 12/21/2012
AP012/18/2012SLR34783034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/19839s073,s081,20990s034s040lbl.pdf 12/28/2012
AP08/19/2011SLR29853036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf 8/24/2011
AP08/19/2011SLR29838036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019839s072,s075,s076,020990s033,s036,s037ltr.pdf 8/22/2011
AP08/19/2011SLR29839037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019839s072,s075,s076,020990s033,s036,s037ltr.pdf 8/22/2011
AP08/19/2011SLR29854037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf 8/24/2011
AP02/1/2013SLR35067038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019839Orig1s079,20990Orig1s038ltr.pdf 2/4/2013
AP02/1/2013SLR35086038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019839s079,020990s038lbl.pdf 2/6/2013
AP07/3/2014SLR39790039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019839Orig1s080,s083,020990Orig1s039,s041ltr.pdf 7/8/2014
AP07/3/2014SLR39805039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s080s083,020990s039s041lbl.pdf 7/8/2014
AP012/18/2012SLR34784040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/19839s073,s081,20990s034s040lbl.pdf 12/28/2012
AP012/18/2012SLR34726040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019839Orig1s073,s081,020990Orig1s034,s040ltr.pdf 12/21/2012
AP07/3/2014SLR39791041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019839Orig1s080,s083,020990Orig1s039,s041ltr.pdf 7/8/2014
AP07/3/2014SLR39806041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s080s083,020990s039s041lbl.pdf 7/8/2014
AP010/15/2013SCM       
AP09/12/2014SLR40499043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/19839Orig1s084,020990Orig1s043ltr.pdf 9/16/2014
AP09/12/2014SLR40518043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s084,020990s043lbl.pdf 9/19/2014




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