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FDA Drug Application 021849 by SANTARUS INC

Application Number021849
Application Type New Drug Application
Sponsor ApplicantSANTARUS INC
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
AP02/27/2006N13714000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021849s000lbl.pdf 3/3/2006
AP02/27/2006N13715000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021849s000ltr.pdf 3/3/2006
AP02/27/2006N19774000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021849TOC.cfm 5/7/2008
AP02/27/2006N31064000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm 12/20/2011
AP012/21/2007SCF18725002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021849s002lbl.pdf 1/8/2008
AP012/21/2007SCF18764002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021849s002ltr.pdf 1/9/2008
AP012/21/2007SCF30809002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021849Orig1s002.pdf 10/10/2011
AP01/20/2010SLR24678003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s008,021849s003,021850s002ltr.pdf 1/29/2010
AP09/3/2010SLR26424004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s009,021849s004,021850s003,022456s002ltr.pdf 9/8/2010
AP09/3/2010SLR26468004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s009,021849s004,021850s003,022456s002lbl.pdf 9/10/2010
AP05/20/2011SLR28932005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021636s010,021849s005ltr.pdf 5/25/2011
AP05/20/2011SLR28951005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021636s010,021849s005lbl.pdf 5/25/2011
AP012/7/2011SLR30931006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021636s011,021849s006ltr.pdf 12/13/2011
AP012/7/2011SLR31001006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021636s011,021849s006lbl.pdf 12/15/2011
AP011/9/2012SLR34373007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021636Orig1s012,021849Orig1s007ltr.pdf 11/14/2012
AP011/9/2012SLR34388007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s012,021849s007mg.pdf 11/15/2012
AP011/9/2012SLR34389007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s012,021849s007lbl.pdf 11/15/2012
AP04/19/2012SLR32479008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s013,021849s008lbl.pdf 4/20/2012
AP04/19/2012SLR32507008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021636s013,021849s008ltr.pdf 4/23/2012
AP02/25/2014SLR38624009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021636s015,021849s009lbl.pdf 2/27/2014
AP02/25/2014SLR38635009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021636Orig1s015,021849Orig1s009ltr.pdf 3/4/2014
AP012/19/2014SLR41390010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021636Orig1s016,021849Orig1s010ltr.pdf 12/24/2014
AP012/19/2014SLR41423010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021849s010021636s016lbl.pdf 12/29/2014
AP06/1/2016SCM       
AP010/24/2016SLR47462012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021849Orig1s012,021636Orig1s017ltr.pdf 10/26/2016
AP010/24/2016SLR47527012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021636s017,021849s012lbl.pdf 10/31/2016




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