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FDA Drug Application 022108 by VALEANT PHARMS NORTH

Application Number022108
Application Type New Drug Application
Sponsor ApplicantVALEANT PHARMS NORTH
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/23/2008N19720000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022108s000ltr.pdf 4/24/2008
AP04/23/2008N19875000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022108lbl.pdf 5/27/2008
AP04/23/2008N19876000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085915.pdf 5/27/2008
AP04/23/2008N22217000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022108s000TOC.cfm 4/7/2009
AP04/23/2008N22218000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022108s000_SumR.pdf 4/7/2009
AP04/29/2011SLR28694002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022108s002ltr.pdf 5/4/2011
AP04/29/2011SLR28664003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022108s003lbl.pdf 5/2/2011
AP04/29/2011SLR28665003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022108s003MedG.pdf 5/2/2011
AP04/29/2011SLR28695003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022108s003ltr.pdf 5/4/2011
AP07/26/2011SLR29609005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022108s005s006lbl.pdf 7/27/2011
AP07/26/2011SLR29611005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022108s005s006MedG.pdf 7/27/2011
AP07/26/2011SLR29627005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021515s026,s027,022108s005,s006ltr.pdf 7/28/2011
AP07/26/2011SLR29610006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022108s005s006lbl.pdf 7/27/2011
AP07/26/2011SLR29628006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021515s026,s027,022108s005,s006ltr.pdf 7/28/2011
AP08/14/2012SE133480007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022108s007mg.pdf 8/15/2012
AP08/14/2012SE133481007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022108s007lbl.pdf 8/15/2012
AP08/14/2012SE133497007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022108Orig1s007ltr.pdf 8/17/2012
AP012/30/2014SLR41502009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021515Orig1s029,s030,022108Orig1s009ltr.pdf 1/7/2015
AP012/30/2014SLR41606009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022108s009lbl.pdf 1/9/2015
AP07/9/2014SLR39828011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022108Orig1s011ltr.pdf 7/10/2014
AP07/9/2014SLR39836011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022108s011lbl.pdf 7/11/2014
AP08/30/2016SLR46943012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022108Orig1s012ltr.pdf 9/2/2016
AP08/30/2016SLR46957012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022108s012lbl.pdf 9/2/2016




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