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FDA Drug Application 021654 by SMITHKLINE BEECHAM

Application Number021654
Application Type New Drug Application
Sponsor ApplicantSMITHKLINE BEECHAM
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
AP011/10/2004N10597000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21654ltr.pdf 11/16/2004
AP011/10/2004N10610000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21654lbl.pdf 11/16/2004
AP011/10/2004N10947000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-654_Omacor.cfm 1/11/2005
AP02/1/2007SLR15742004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021654s004lbl.pdf 2/2/2007
AP02/1/2007SLR15792004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021654s004ltr.pdf 2/12/2007
AP07/3/2006SCM14465007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021654s007LTR.pdf 7/13/2006
AP011/7/2007SLR18344014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021654s014pi.pdf 11/7/2007
AP011/7/2007SLR18351014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021654s014ltr.pdf 11/8/2007
AP012/6/2007SCM18856015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021654s015ltr.pdf 1/9/2008
AP06/12/2007SLR16920016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021853s000, 021654s016ltr.pdf 7/5/2007
AP06/12/2007SLR23980016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021853_021654s016_omacor_toc.cfm 11/19/2009
AP01/24/2008SCM30969018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021654Orig1s018.pdf 12/14/2011
AP06/3/2008SLR19962021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021654s021ltr.pdf 6/6/2008
AP06/3/2008SLR20034021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021654s021lblR.pdf 6/19/2008
AP09/16/2009SE823424022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021654s022lbl.pdf 9/21/2009
AP09/16/2009SE823782022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021654s022ltr.pdf 11/10/2009
AP04/20/2009SLR22300023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021654s023ltr.pdf 4/21/2009
AP04/20/2009SLR22313023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021654s023lbl.pdf 4/23/2009
AP012/22/2010SLR27378030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021654s030lbl.pdf 12/26/2010
AP012/22/2010SLR27404030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021654s030ltr.pdf 12/28/2010
AP08/11/2011SLR       
AP09/19/2011SLR30052033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021654s033ltr.pdf 9/21/2011
AP09/4/2012SLR33652034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021654Orig1s034ltr.pdf 9/6/2012
AP09/4/2012SLR33673034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021654s034lbl.pdf 9/6/2012
AP06/26/2013SLR36392037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021654Orig1s037ltr.pdf 6/27/2013
AP06/26/2013SLR36505037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021654s037lbl.pdf 7/8/2013
AP011/15/2013SCM       
AP09/11/2013SCM37129039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021654s039lbl.pdf 9/17/2013
AP06/5/2014SCM       
AP05/14/2014SLR39302041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021654s041lbl.pdf 5/14/2014
AP05/14/2014SLR39303041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021654s041ltr.pdf 5/14/2014
AP03/9/2015SCM       




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