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FDA Drug Application 203188 by VERTEX PHARMS

Application Number203188
Application Type New Drug Application
Sponsor ApplicantVERTEX PHARMS
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
AP01/31/2012N31599000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203188lbl.pdf 1/31/2012
AP01/31/2012N31600000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203188s000ltr.pdf 1/31/2012
AP01/31/2012N32099000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203188s000TOC.cfm 3/13/2012
AP01/31/2012N34043000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm323671.htm 10/12/2012
AP08/28/2012SLR33584001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203188s001lbl.pdf 8/29/2012
AP08/28/2012SLR33586001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203188Orig1s001ltr.pdf 8/29/2012
AP06/3/2013SCM       
AP012/13/2013SCM       
AP02/21/2014SE838568004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203188Orig1s004ltr.pdf 2/25/2014
AP02/21/2014SE838584004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s004lbl.pdf 2/25/2014
AP06/13/2014SLR39563007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s007lbl.pdf 6/17/2014
AP06/13/2014SLR39578007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203188Orig1s007ltr.pdf 6/18/2014
AP04/8/2014SLR39019008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203188Orig1s008ltr.pdf 4/10/2014
AP04/8/2014SLR39025008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s008lbl.pdf 4/10/2014
AP011/24/2015SCM       
AP03/9/2015SCM       
AP07/29/2014SCM       
AP011/10/2014SCM       
AP012/11/2014SCM       
AP012/29/2014SE841496014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203188Orig1s014,s015ltr.pdf 1/6/2015
AP012/29/2014SE841605014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s014lbl.pdf 1/9/2015
AP012/29/2014SLR41608015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s014s015lbl.pdf 1/9/2015
AP012/29/2014SLR41497015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203188Orig1s014,s015ltr.pdf 1/6/2015
AP01/5/2015SCM       
AP03/4/2015SLR42039017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203188Orig1s017ltr.pdf 3/6/2015
AP03/4/2015SLR42230017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203188s017lbl.pdf 3/20/2015
AP09/1/2015SCM       
AP05/20/2016SCM       
AP08/31/2016SCM       




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