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FDA Drug Application 022554 by SALIX PHARMS

Application Number022554
Application Type New Drug Application
Sponsor ApplicantSALIX PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New indication
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/24/2010N25111000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022554lbl.pdf 3/26/2010
AP03/24/2010N25137000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022554s000ltr.pdf 3/29/2010
AP03/24/2010N29603000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022554_xifaxan_toc_.cfm 7/26/2011
AP03/24/2010N29604000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022554Orig1s000SumR.pdf 7/26/2011
AP03/24/2010N44397000Latest label for Xifaxan (original NDA 021361)  http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021361s012lbledt.pdf 11/5/2015




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