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FDA Drug Application 021636 by SANTARUS INC

Application Number021636
Application Type New Drug Application
Sponsor ApplicantSANTARUS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation; New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/15/2004N9404000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21636ltr.pdf 6/16/2004
AP06/15/2004N9409000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21636_zegerid_lbl.pdf 6/16/2004
AP06/15/2004N13222000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021636s000_ZegeridTOC.cfm 12/6/2005
AP06/15/2004N31062000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm 12/20/2011
AP01/20/2010SLR24677008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s008,021849s003,021850s002ltr.pdf 1/29/2010
AP01/20/2010SLR26102008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s008lbl.pdf 8/5/2010
AP09/3/2010SLR26423009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s009,021849s004,021850s003,022456s002ltr.pdf 9/8/2010
AP09/3/2010SLR26469009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s009,021849s004,021850s003,022456s002lbl.pdf 9/10/2010
AP05/20/2011SLR28931010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021636s010,021849s005ltr.pdf 5/25/2011
AP05/20/2011SLR28952010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021636s010,021849s005lbl.pdf 5/25/2011
AP012/7/2011SLR30930011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021636s011,021849s006ltr.pdf 12/13/2011
AP012/7/2011SLR30936011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021636s011,021849s006lbl.pdf 12/13/2011
AP011/9/2012SLR34372012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021636Orig1s012,021849Orig1s007ltr.pdf 11/14/2012
AP011/9/2012SLR34390012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s012,021849s007lbl.pdf 11/15/2012
AP011/9/2012SLR34391012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s012,021849s007mg.pdf 11/15/2012
AP04/19/2012SLR32480013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s013,021849s008lbl.pdf 4/20/2012
AP04/19/2012SLR32506013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021636s013,021849s008ltr.pdf 4/23/2012
AP012/20/2013SCM       
AP02/25/2014SLR38623015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021636s015,021849s009lbl.pdf 2/27/2014
AP02/25/2014SLR38634015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021636Orig1s015,021849Orig1s009ltr.pdf 3/4/2014
AP012/19/2014SLR41389016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021636Orig1s016,021849Orig1s010ltr.pdf 12/24/2014
AP012/19/2014SLR41424016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021849s010021636s016lbl.pdf 12/29/2014
AP010/24/2016SLR47463017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021849Orig1s012,021636Orig1s017ltr.pdf 10/26/2016
AP010/24/2016SLR47528017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021636s017,021849s012lbl.pdf 10/31/2016




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