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FDA Drug Application 021361 by SALIX PHARMS

Application Number021361
Application Type New Drug Application
Sponsor ApplicantSALIX PHARMS
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
AP05/25/2004N8828000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21361ltr.pdf 6/1/2004
AP05/25/2004N8840000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21361_xifaxan_lbl.pdf 6/1/2004
AP05/25/2004N10089000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-361_Xifaxan.cfm 8/27/2004
AP01/30/2007SLR15736006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021361s006lbl.pdf 2/2/2007
AP01/30/2007SLR15781006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021361s006ltr.pdf 2/12/2007
AP011/15/2010SLR26970009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021361s009lbl.pdf 11/17/2010
AP011/15/2010SLR26986009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021361s009ltr.pdf 11/18/2010
AP03/3/2010SLR24974011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021361s011lbl.pdf 3/5/2010
AP03/3/2010SLR24990011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021361s011ltr.pdf 3/8/2010
AP05/27/2015SE842923012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021361Orig1s012ltr.pdf 5/28/2015
AP05/27/2015SE842941012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021361s012lbledt.pdf 5/29/2015
AP03/12/2014SLR38783013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021361s013lbl.pdf 3/13/2014
AP03/12/2014SLR38794013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021361Orig1s013ltr.pdf 3/14/2014
AP04/23/2015SCM       
AP06/16/2016SCM       
AP010/15/2015SCM       




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