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FDA Drug Application 020607 by GD SEARLE LLC

Application Number020607
Application Type New Drug Application
Sponsor ApplicantGD SEARLE LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/24/1997N6444000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020607_arthrotec_toc.cfm 8/8/2003
AP012/24/1997N23712000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085919.pdf 10/30/2009
AP04/15/1998SCP       
AP03/16/1998SCP       
AP07/20/1998SCS       
AP02/22/1999SLR1014004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20607s4.pdf 2/22/1999
AP010/3/2000SLR       
AP05/20/2002SCM       
AP07/8/2005SLR11997008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020607s008ltr.pdf 7/15/2005
AP01/25/2006SLR13476009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020607s009lbl.pdf 1/25/2006
AP01/25/2006SLR13540009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020607s009ltr.pdf 1/30/2006
AP08/24/2007SLR17709010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020607s010lbl.pdf 8/27/2007
AP08/24/2007SLR17712010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020607s010ltr.pdf 8/27/2007
AP09/11/2009SLR23532013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020607s013lbl.pdf 10/6/2009
AP09/11/2009SLR23808013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020607s013ltr.pdf 11/10/2009
AP02/25/2009SLR21918014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020607s014ltr.pdf 2/27/2009
AP02/25/2009SLR22018014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020607s014lbl.pdf 3/17/2009
AP012/21/2010SLR27342016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020607s016lbl.pdf 12/22/2010
AP012/21/2010SLR27345016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020607s016ltr.pdf 12/22/2010
AP04/1/2015SLR42385021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020607s021lbl.pdf 4/2/2015
AP04/1/2015SLR42416021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020607Orig1s021ltr.pdf 4/3/2015
AP03/7/2013SLR35358025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020607Orig1s025ltr.pdf 3/8/2013
AP03/7/2013SLR35379025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020607s025lbl.pdf 3/8/2013
AP02/8/2013SCM       
AP09/3/2014SLR40417028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020607Orig1s028ltr.pdf 9/5/2014
AP09/3/2014SLR40466028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020607s028lbl.pdf 9/9/2014
AP05/9/2016SLR45991031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020607s031lbl.pdf 5/11/2016
AP05/9/2016SLR46012031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020607Orig1s031ltr.pdf 5/12/2016




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