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FDA Drug Application 019839 by PFIZER

Application Number	019839
Application Type	New Drug Application
Sponsor Applicant	PFIZER
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New molecular entity (NME)
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	12/30/1991	N	12374	000	http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm053351.htm	7/29/2005
AP	12/30/1991	N	24206	000	http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089832.pdf	12/4/2009
AP	6/22/1992	SCM
AP	10/25/1996	SE1
AP	9/14/1995	SLR
AP	9/7/1994	SCF
AP	6/16/1995	SLR
AP	3/22/1995	SCS
AP	6/16/1995	SLR
AP	10/5/1995	SCM
AP	3/6/1996	SCS
AP	7/8/1997	SE1	4363	011	http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019839_s011ap.pdf	7/8/1997
AP	3/5/1996	SCM
AP	10/10/1997	SE5	4364	017	http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019839ap.pdf	10/10/1997
AP	10/10/1997	SLR	4365	018	http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019839ap.pdf	10/10/1997
AP	4/7/1997	SCS
AP	12/4/1997	SCS
AP	4/10/1998	SCS
AP	12/7/1999	SE1	2171	026	http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19-839S026_Zoloft.cfm	12/7/1999
AP	12/7/1999	SE1	5208	026	http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19-839S026_Zoloft_Approv.pdf	12/7/1999
AP	12/7/1999	SE1	5209	026	http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19-839S026_Zoloft_prntlbl.pdf	12/7/1999
AP	2/22/2001	SLR
AP	10/7/1999	SCM
AP	10/7/1999	SCM
AP	1/3/2000	SCP
AP	3/17/2000	SCM
AP	10/12/2001	SE8	5489	033	http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20990s1lbl.pdf	4/25/2003
AP	10/12/2001	SE8	6294	033	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19839s33ltr.pdf	7/31/2003
AP	9/20/2002	SE8
AP	8/6/2001	SE8	2164	035	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19839s35ltr.pdf	8/17/2001
AP	8/6/2001	SE8	2165	035	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-839S035_Zoloft_Prntlbl.pdf	8/17/2001
AP	8/6/2001	SE8	2166	035	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-839S35_Zoloft.cfm	8/17/2001
AP	9/20/2002	SE8	2160	036	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20990Se802,04,19839SE8-034,036LTR.pdf	9/20/2002
AP	2/22/2001	SLR
AP	11/16/2000	SLR
AP	5/16/2002	SE1	2155	039	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19-839s039ltr.pdf	5/16/2002
AP	5/16/2002	SE1	2156	039	http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19839s39lbl.pdf	5/16/2002
AP	7/12/2001	SCM
AP	1/9/2002	SCM
AP	9/18/2002	SLR	2153	043	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19839slr043,20990slr009ltr.pdf	9/18/2002
AP	9/16/2003	SE5	6670	044	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19839se5-se5-044,20990se5-010ltr.pdf	9/25/2003
AP	9/16/2003	SE5	6680	044	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19839se5-se5-044,20990se5-010_zoloft_lbl.pdf	9/25/2003
AP	9/16/2003	SE5	15925	044	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019839s044,020990s010_ZoloftTOC.cfm	3/2/2007
AP	2/7/2003	SE1	4137	045	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020990s011lbl.pdf	3/5/2003
AP	2/7/2003	SE1	9664	045	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19839se1-045,20990se1-011ltr.pdf	7/1/2004
AP	8/19/2004	SE8	10056	047	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19839s047,050,20990s013,017ltr.pdf	8/25/2004
AP	8/19/2004	SE8	10068	047	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19839s047,050,20990s013,017lbl.pdf	8/25/2004
AP	8/19/2004	SLR	10057	050	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19839s047,050,20990s013,017ltr.pdf	8/25/2004
AP	8/19/2004	SLR	10069	050	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19839s047,050,20990s013,017lbl.pdf	8/25/2004
AP	2/18/2005	SLR	11154	053	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19839s053,054,20990s019,020ltr.pdf	2/23/2005
AP	2/18/2005	SLR	11982	053	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019839s053S054lbl.pdf	7/14/2005
AP	2/18/2005	SLR	11155	054	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19839s053,054,20990s019,020ltr.pdf	2/23/2005
AP	2/18/2005	SLR	11983	054	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019839s053S054lbl.pdf	7/14/2005
AP	7/26/2005	SLR	12351	055	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019839s055,020990s022ltr.pdf	7/29/2005
AP	5/4/2006	SLR	14115	057	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019839s057, 020990s023ltr.pdf	5/16/2006
AP	9/14/2006	SLR	14819	058	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019839s058s060,020990s024s026lbl.pdf	9/15/2006
AP	9/14/2006	SLR	14828	058	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019839s058, 019839s060, 020990s024, 020990s026ltr.pdf	9/15/2006
AP	8/2/2007	SLR	17573	059	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/01190516s2316798s5417516s2320990s252719839s596364ltr.pdf	8/7/2007
AP	9/14/2006	SLR	14820	060	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019839s058s060,020990s024s026lbl.pdf	9/15/2006
AP	9/14/2006	SLR	14829	060	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019839s058, 019839s060, 020990s024, 020990s026ltr.pdf	9/15/2006
AP	8/2/2007	SLR	17485	063	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019839s063s064,020990s027lbl.pdf	8/3/2007
AP	8/2/2007	SLR	17574	063	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/01190516s2316798s5417516s2320990s252719839s596364ltr.pdf	8/7/2007
AP	8/2/2007	SLR	17486	064	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019839s063s064,020990s027lbl.pdf	8/3/2007
AP	8/2/2007	SLR	17575	064	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/01190516s2316798s5417516s2320990s252719839s596364ltr.pdf	8/7/2007
AP	10/4/2007	SLR	18204	065	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019839s065, 020990s029ltr.pdf	10/10/2007
AP	10/4/2007	SLR	18226	065	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019839s065,020990s029lbl.pdf	10/10/2007
AP	3/6/2008	SLR	19386	068	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019839s068, 20990s031ltr.pdf	3/7/2008
AP	3/6/2008	SLR	19400	068	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019839s068,020990s031lbl.pdf	3/7/2008
AP	1/30/2009	SLR	21735	070	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019839s070,020990s032ltr.pdf	2/3/2009
AP	1/30/2009	SLR	21755	070	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019839s070,020990s032lbl.pdf	2/4/2009
AP	8/19/2011	SLR	29834	072	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019839s072,s075,s076,020990s033,s036,s037ltr.pdf	8/22/2011
AP	8/19/2011	SLR	29855	072	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf	8/24/2011
AP	12/18/2012	SLR	34723	073	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019839Orig1s073,s081,020990Orig1s034,s040ltr.pdf	12/21/2012
AP	12/18/2012	SLR	34781	073	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/19839s073,s081,20990s034s040lbl.pdf	12/28/2012
AP	8/19/2011	SLR	29835	075	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019839s072,s075,s076,020990s033,s036,s037ltr.pdf	8/22/2011
AP	8/19/2011	SLR	29856	075	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf	8/24/2011
AP	8/19/2011	SLR	29836	076	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019839s072,s075,s076,020990s033,s036,s037ltr.pdf	8/22/2011
AP	8/19/2011	SLR	29857	076	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf	8/24/2011
AP	2/1/2013	SLR	35066	079	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019839Orig1s079,20990Orig1s038ltr.pdf	2/4/2013
AP	2/1/2013	SLR	35087	079	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019839s079,020990s038lbl.pdf	2/6/2013
AP	7/3/2014	SLR	39788	080	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019839Orig1s080,s083,020990Orig1s039,s041ltr.pdf	7/8/2014
AP	7/3/2014	SLR	39803	080	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s080s083,020990s039s041lbl.pdf	7/8/2014
AP	12/18/2012	SLR	34724	081	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019839Orig1s073,s081,020990Orig1s034,s040ltr.pdf	12/21/2012
AP	12/18/2012	SLR	34782	081	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/19839s073,s081,20990s034s040lbl.pdf	12/28/2012
AP	9/26/2013	SCM
AP	7/3/2014	SLR	39789	083	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019839Orig1s080,s083,020990Orig1s039,s041ltr.pdf	7/8/2014
AP	7/3/2014	SLR	39804	083	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s080s083,020990s039s041lbl.pdf	7/8/2014
AP	9/12/2014	SLR	40498	084	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/19839Orig1s084,020990Orig1s043ltr.pdf	9/16/2014
AP	9/12/2014	SLR	40519	084	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s084,020990s043lbl.pdf	9/19/2014
AP	1/10/2014	SCM

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