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FDA Drug Application 021881 by SALIX PHARMS

Application Number021881
Application Type New Drug Application
Sponsor ApplicantSALIX PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/2/2006N14594000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021881lbl.pdf 8/4/2006
AP08/2/2006N14630000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021881s000LTR.pdf 8/7/2006
AP08/2/2006N20754000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021881_moviprep_toc.cfm 9/5/2008
AP08/2/2006N37175000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM253840.pdf 9/20/2013
AP02/5/2008SLR19065003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021881s003ltr.pdf 2/7/2008
AP011/20/2008SLR       
AP04/28/2011SLR28656008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021881s008MedG.pdf 4/29/2011
AP04/28/2011SLR28657008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021881s008lbl.pdf 4/29/2011
AP04/28/2011SLR28678008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021881s008ltr.pdf 5/3/2011
AP011/2/2010SLR26880010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021881s010lbl.pdf 11/2/2010
AP011/2/2010SLR26887010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021881s010ltr.pdf 11/4/2010
AP08/29/2012SLR33599012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021881Orig1s012ltr.pdf 8/30/2012
AP08/29/2012SLR33610012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021881s012mg.pdf 8/31/2012
AP08/29/2012SLR33611012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021881s012lbl.pdf 8/31/2012
AP09/12/2013SLR37093015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021881Orig1s015ltr.pdf 9/13/2013
AP09/12/2013SLR37115015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021881s015lbl.pdf 9/17/2013
AP012/17/2013SLR38104016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021881s016lbl.pdf 12/19/2013
AP012/17/2013SLR38111016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021881Orig1s016ltr.pdf 12/19/2013




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