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FDA Drug Application 021894 by VALEANT PHARMS NORTH

Application Number021894
Application Type New Drug Application
Sponsor ApplicantVALEANT PHARMS NORTH
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/15/2008N20654000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021894s000ltr.pdf 8/21/2008
AP08/15/2008N20682000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021894lbl.pdf 8/26/2008
AP08/15/2008N20989000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021894s000TOC.cfm 10/9/2008
AP08/15/2008N20990000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021894s000_SumR.pdf 10/9/2008
AP08/15/2008N24188000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089827.pdf 12/3/2009
AP012/1/2009SLR24648001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021894s001s002ltr.pdf 1/27/2010
AP012/1/2009SLR24649002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021894s001s002ltr.pdf 1/27/2010
AP07/6/2011SLR29448004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021894s004ltr.pdf 7/7/2011
AP07/6/2011SLR29450004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021894s004lbl.pdf 7/7/2011
AP05/4/2011SLR28714005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021894s005MedG.pdf 5/5/2011
AP05/4/2011SLR28715005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021894s005lbl.pdf 5/5/2011
AP05/4/2011SLR28725005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021894s005ltr.pdf 5/6/2011
AP08/17/2012SLR33553007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021894Orig1s007ltr.pdf 8/27/2012
AP08/2/2013SLR36691009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021894Orig1s009ltr.pdf 8/5/2013
AP06/3/2015SLR42981010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021894Orig1s010ltr.pdf 6/4/2015
AP06/3/2015SLR42988010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021894s010lbl.pdf 6/4/2015
AP08/25/2015S43734012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021894Orig1s012ltr.pdf 8/27/2015




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