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FDA Drug Application 021892 by SALIX PHARMS

Application Number021892
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
AP03/16/2006N20750000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021892_osmoprep_toc.cfm 9/5/2008
AP03/16/2006N13791000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021892s000lbl.pdf 3/22/2006
AP03/16/2006N13793000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021892s000ltr.pdf 3/23/2006
AP09/18/2007SLR17982001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021892s001ltr.pdf 9/25/2007
AP012/10/2008SLR21362002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021892s002ltr.pdf 12/19/2008
AP03/25/2009SLR22116003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021892s003lbl.pdf 3/26/2009
AP03/25/2009SLR22131003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021097s013,021892s003ltr.pdf 3/27/2009
AP03/25/2009SLR30819003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021892Orig1s003.pdf 10/10/2011
AP010/13/2009SLR23573004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021892s004MEDGUIDE.pdf 10/14/2009
AP010/13/2009SLR23574004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021097s014,021892s004lbl.pdf 10/14/2009
AP010/13/2009SLR24146004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021097s014,021892s004ltr.pdf 11/25/2009
AP010/5/2012SLR34012006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021892s006lbl.pdf 10/9/2012
AP010/5/2012SLR34013006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021892s006mg.pdf 10/9/2012
AP010/5/2012SLR34023006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021892Orig1s006ltr.pdf 10/10/2012
AP012/9/2011SLR30962009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021892s009,021097s015ltr.pdf 12/14/2011
AP09/15/2015SCM       
AP06/21/2016SCM       




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