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FDA Drug Application 201917 by VERTEX PHARMS

Application Number201917
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 Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/23/2011N28878000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201917lbl.pdf 5/23/2011
AP05/23/2011N28879000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM256383.pdf 5/23/2011
AP05/23/2011N28880000   http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm256299.htm 5/23/2011
AP05/23/2011N28881000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201917Orig1s000ltr.pdf 5/23/2011
AP05/23/2011N29459000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201917Orig1s000TOC.cfm 7/8/2011
AP05/23/2011N29460000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201917Orig1s000SumR.pdf 7/8/2011
AP05/23/2011N34770000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm332743.htm 12/27/2012
AP03/22/2012SLR32177003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201917s003lbl.pdf 3/23/2012
AP03/22/2012SLR32178003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201917s003mg.pdf 3/23/2012
AP03/22/2012SLR32187003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201917s003ltr.pdf 3/26/2012
AP06/22/2012SLR32991004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201917s004ltr.pdf 6/25/2012
AP06/22/2012SLR33023004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201917s004lbl.pdf 6/26/2012
AP06/22/2012SLR33024004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201917s004mg.pdf 6/26/2012
AP011/27/2012SCM       
AP012/14/2012SLR34671007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201917s007lbl.pdf 12/17/2012
AP012/14/2012SLR34709007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201917Orig1s007ltr.pdf 12/19/2012
AP04/25/2013SLR35867008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201917s008lbl.pdf 4/29/2013
AP04/25/2013SLR35883008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201917Orig1s008ltr.pdf 4/30/2013
AP05/8/2013SCM       
AP010/28/2013SE837601010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201917s010lbl.pdf 10/28/2013
AP010/28/2013SE837604010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201917Orig1s010,s012ltr.pdf 10/29/2013
AP07/22/2013SCM       
AP010/28/2013SLR37600012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201917s012lbl.pdf 10/28/2013
AP010/28/2013SLR37605012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201917Orig1s010,s012ltr.pdf 10/29/2013
AP03/25/2014SCM       




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