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FDA Drug Application 205755 by NOVARTIS PHARMS CORP

Application Number205755
Application Type New Drug Application
Sponsor ApplicantNOVARTIS PHARMS CORP
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
AP04/29/2014N39166000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205755s000lbl.pdf 4/29/2014
AP04/29/2014N39177000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205755Orig1s000ltr.pdf 4/30/2014
AP04/29/2014N39313000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205755Orig1s000TOC.cfm 5/16/2014
AP04/29/2014N39314000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205755Orig1s000SumR.pdf 5/16/2014
AP010/30/2014SCM       
AP06/24/2015SCM       
AP07/22/2015SLR43464003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205755Orig1s003,s004ltr.pdf 7/23/2015
AP07/22/2015SLR43477003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205755s003s004lbl.pdf 7/24/2015
AP07/22/2015SLR43465004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205755Orig1s003,s004ltr.pdf 7/23/2015
AP07/22/2015SLR43478004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205755s003s004lbl.pdf 7/24/2015
AP08/25/2015SCM       
AP09/7/2016SLR46994006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205755Orig1s006ltr.pdf 9/8/2016
AP09/7/2016SLR47009006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205755s006lbl.pdf 9/9/2016
AP09/15/2016SCM       




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