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FDA Drug Application 021176 by DAIICHI SANKYO

Application Number021176
Application Type New Drug Application
Sponsor ApplicantDAIICHI SANKYO
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
AP05/26/2000N7188000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-141_Welchol.cfm 4/11/2002
AP05/26/2000N9640000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-141_Welchol_Approv.pdf 6/30/2004
AP05/26/2000N9641000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-141_Welchol_prntlbl.pdf 6/30/2004
AP01/16/2001SCP       
AP05/3/2001SCS       
AP05/10/2002SCS       
AP02/11/2003SLR9639004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21176slr004ltr.pdf 6/30/2004
AP02/11/2003SLR4135004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021176s004lbl.pdf 3/5/2003
AP010/17/2002SCP2827005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21176scp005ltr.pdf 10/17/2002
AP010/17/2002SCP2828005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21176s5lbl.pdf 10/17/2002
AP08/8/2002SCS       
AP08/21/2003SCS6559008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21176scs008ltr.pdf 8/28/2003
AP08/21/2003SCS6560008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21176scs008_welchol_lbl.pdf 8/28/2003
AP010/10/2003SLR6810009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21176slr009ltr.pdf 10/16/2003
AP010/10/2003SLR6811009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21176slr009_welChol_lbl.pdf 10/16/2003
AP011/17/2003SCS6941010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21176scs010ltr.pdf 11/25/2003
AP011/17/2003SCS7040010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21176scs010_welchol_lbl.pdf 12/2/2003
AP09/6/2006SE814804014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021176s014lbl.pdf 9/12/2006
AP09/6/2006SE814843014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021176s014_ltr.pdf 9/18/2006
AP07/10/2006SLR14445015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021176s015lbl.pdf 7/13/2006
AP07/10/2006SLR14451015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021176s015LTR.pdf 7/13/2006
AP01/18/2008SE118922017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021176s017lbl.pdf 1/23/2008
AP01/18/2008SE118930017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021176s017ltr.pdf 1/23/2008
AP08/27/2007SLR17724019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021176s019lbl.pdf 8/30/2007
AP08/27/2007SLR17728019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021176s019ltr.pdf 8/30/2007
AP05/30/2008SCM19959021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021176s021ltr.pdf 6/6/2008
AP010/2/2009SE523550022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022362lbl.pdf 10/7/2009
AP010/2/2009SE523674022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021176s022_022362s000ltr.pdf 10/26/2009
AP09/14/2010SLR26491027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021176s027,022362s002ltr.pdf 9/16/2010
AP09/14/2010SLR26512027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021176s027,022362s002lbl.pdf 9/20/2010
AP07/18/2011SLR29542028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021176s028lbl.pdf 7/18/2011
AP07/18/2011SLR29544028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022362s007,021176s028ltr.pdf 7/19/2011
AP01/3/2012SLR31360029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021176s029,022362s009lbl.pdf 1/6/2012
AP01/3/2012SLR31396029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021176s029,022362s009ltr.pdf 1/17/2012
AP07/9/2012SLR33169030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021176Orig1s030,022362Orig1s010ltr.pdf 7/13/2012
AP07/9/2012SLR33178030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021176s030,022362s010lbl.pdf 7/13/2012
AP06/28/2013SE836422034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021176s034s038,022362s015s017s018lbl.pdf 7/2/2013
AP06/28/2013SE836423034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021176Orig1s034,s038,022362Orig1s015,s017,s018ltr_replace.pdf 7/2/2013
AP04/22/2013SCM       
AP02/25/2013SCM       
AP01/22/2014SE838353037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021176Orig1s037,022362Orig1s020ltr.pdf 1/23/2014
AP01/22/2014SE838359037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021176s037,022362s020lbl.pdf 1/23/2014
AP06/28/2013SLR36424038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021176s034s038,022362s015s017s018lbl.pdf 7/2/2013
AP06/28/2013SLR36425038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021176Orig1s034,s038,022362Orig1s015,s017,s018ltr_replace.pdf 7/2/2013
AP05/20/2014SCM       
AP07/14/2016SCM       
AP09/2/2016SCM       




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