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FDA Drug Application 020639 by ASTRAZENECA PHARMS

Application Number020639
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA PHARMS
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
AP09/26/1997N16535000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 5/9/2007
AP09/26/1997N17294000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20639_seroquel_toc.cfm 7/17/2007
AP09/26/1997N24078000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089126.pdf 11/20/2009
AP09/26/1997N31199000Other Important Information from FDA  http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm 12/22/2011
AP02/23/1998SCM       
AP05/8/1998SCM       
AP012/20/1998SCM       
AP07/26/2000SCM       
AP07/7/2000SCM       
AP01/24/2001SCM       
AP011/6/2000SCM       
AP03/27/2001SLR1620011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20639S11LTR.PDF 3/27/2001
AP03/19/2001SCP       
AP011/16/2001SCM       
AP012/6/2002SCM       
AP01/12/2004SE17539016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20639se1-017,016ltr.pdf 1/14/2004
AP01/12/2004SE17551016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20639se1-017,016_seroquel_lbl.pdf 1/15/2004
AP01/12/2004SE118533016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020639_S016&S017_SEROQUEL TABLETS.pdf 11/19/2007
AP01/12/2004SE118532017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020639_S016&S017_SEROQUEL TABLETS.pdf 11/19/2007
AP01/12/2004SE17552017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20639se1-017,016_seroquel_lbl.pdf 1/15/2004
AP01/12/2004SE17540017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20639se1-017,016ltr.pdf 1/14/2004
AP07/21/2004SLR9831020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20639s020ltr.pdf 7/21/2004
AP07/21/2004SLR9838020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20639s020lbl.pdf 7/21/2004
AP02/7/2006SCM13599021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020639s021ltr.pdf 2/8/2006
AP09/20/2006SLR14940023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020639s023lbl.pdf 9/21/2006
AP09/20/2006SLR14953023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020639s023ltr.pdf 9/25/2006
AP05/13/2008SLR19827025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s025,se1-037,s038,s040ltr.pdf 5/14/2008
AP05/13/2008SLR19938025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020639s025s037s038s040lbl.pdf 6/5/2008
AP010/20/2006SE115144026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020639s026lbl.pdf 10/23/2006
AP010/20/2006SE115180026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020639s026ltr.pdf 10/23/2006
AP010/24/2008SCA21086030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s030ltr.pdf 10/28/2008
AP01/28/2008SLR18976031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s031ltr.pdf 1/30/2008
AP07/30/2007SLR17469035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020639s035ltr.pdf 8/2/2007
AP05/13/2008SE119828037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s025,se1-037,s038,s040ltr.pdf 5/14/2008
AP05/13/2008SE119937037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020639s025s037s038s040lbl.pdf 6/5/2008
AP05/13/2008SE120221037   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020639se1-037_SUMR.pdf 7/16/2008
AP05/13/2008SE130057037   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020639s037.pdf 9/22/2011
AP05/13/2008SLR19936038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020639s025s037s038s040lbl.pdf 6/5/2008
AP05/13/2008SLR19829038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s025,se1-037,s038,s040ltr.pdf 5/14/2008
AP01/28/2008SLR18977039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s039ltr.pdf 1/30/2008
AP05/13/2008SLR19830040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s025,se1-037,s038,s040ltr.pdf 5/14/2008
AP05/13/2008SLR19935040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020639s025s037s038s040lbl.pdf 6/5/2008
AP08/14/2008SLR20628043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s043ltr.pdf 8/19/2008
AP012/2/2009SE524271045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020639s045s046lbl.pdf 12/11/2009
AP012/2/2009SE524651045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020639s045s046ltr.pdf 1/27/2010
AP012/2/2009SE524652046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020639s045s046ltr.pdf 1/27/2010
AP012/2/2009SE524272046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020639s045s046lbl.pdf 12/11/2009
AP07/8/2011SLR29493049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020639s049s054MedG.pdf 7/12/2011
AP07/8/2011SLR29482049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020639s049,020639s054ltr.pdf 7/12/2011
AP07/8/2011SLR29491049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020639s049s054lbl.pdf 7/12/2011
AP07/8/2011SLR32058049   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020639_seroquel_toc.cfm 3/7/2012
AP05/17/2011SLR28859051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020639s051ltr.pdf 5/19/2011
AP05/17/2011SLR28904051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020639s051lbl.pdf 5/23/2011
AP012/1/2010SLR27185052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020639s052lbl.pdf 12/4/2010
AP012/1/2010SLR27217052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020639s052ltr.pdf 12/6/2010
AP04/30/2013SLR35903053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s053s057s058s059lbl.pdf 5/1/2013
AP04/30/2013SLR35925053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf 5/2/2013
AP07/8/2011SLR29492054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020639s049s054lbl.pdf 7/12/2011
AP07/8/2011SLR29483054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020639s049,020639s054ltr.pdf 7/12/2011
AP07/8/2011SLR29494054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020639s049s054MedG.pdf 7/12/2011
AP07/8/2011SLR32059054   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020639_seroquel_toc.cfm 3/7/2012
AP011/9/2011SLR30554055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020639s055MG.pdf 11/10/2011
AP011/9/2011SLR30565055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020639s055ltr.pdf 11/14/2011
AP04/30/2013SE835926057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf 5/2/2013
AP04/30/2013SE835904057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s053s057s058s059lbl.pdf 5/1/2013
AP04/30/2013SLR35905058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s053s057s058s059lbl.pdf 5/1/2013
AP04/30/2013SLR35927058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf 5/2/2013
AP04/30/2013SLR35928059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf 5/2/2013
AP04/30/2013SLR35906059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s053s057s058s059lbl.pdf 5/1/2013
AP010/29/2013SLR37615061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s061,022047Orig1s034ltr.pdf 10/30/2013
AP010/29/2013SLR37645061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s061lbl.pdf 10/31/2013
AP06/17/2016SLR46360064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020639Orig1s064,022047Orig1s038ltr.pdf 6/21/2016
AP06/17/2016SLR46382064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020639s064lbl.pdf 6/21/2016




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