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FDA Drug Application 205353 by NOVARTIS PHARMS CORP

Application Number205353
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
AP02/23/2015N41888000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205353s000lbl.pdf 2/23/2015
AP02/23/2015N41901000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205353Orig1s000ltr.pdf 2/24/2015
AP02/23/2015N41913000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=344 2/25/2015
AP02/23/2015N41993000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM436377.pdf 3/3/2015
AP02/23/2015N42161000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205353Orig1s000TOC.cfm 3/17/2015
AP02/23/2015N42162000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205353Orig1s000SumR.pdf 3/17/2015
AP06/6/2016SLR46271001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205353Orig1s001ltr.pdf 6/8/2016




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