Back to FDA Applications sponsored by SALIX PHARMS

FDA Drug Application 021964 by SALIX PHARMS

Application Number021964
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
AP04/24/2008N19736000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021964s000ltr.pdf 4/28/2008
AP04/24/2008N19925000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021964s000TOC.cfm 6/3/2008
AP011/4/2009SLR24096006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021964s006lbl.pdf 11/23/2009
AP011/4/2009SLR24572006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021964s006ltr.pdf 1/21/2010
AP07/23/2010SLR26031009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021964s009ltr.pdf 7/28/2010
AP07/23/2010SLR26053009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021964s009lbl.pdf 7/30/2010
AP09/29/2014SE840676010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021964s010lbl.pdf 9/30/2014
AP09/29/2014SE840688010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021964Orig1s010ltr.pdf 10/2/2014
AP09/29/2014SE840722010   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM417497.pdf 10/6/2014
AP08/23/2013SLR36889011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021964s011lbl.pdf 8/27/2013
AP08/23/2013SLR36901011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021964Orig1s011ltr.pdf 8/27/2013
AP04/30/2015SCM       
AP012/20/2013SCM       
AP02/9/2015SCM       
AP02/5/2016SCM       




Back to FDA Applications sponsored by SALIX PHARMS