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FDA Drug Application 204114 by NOVARTIS PHARMS CORP

Application Number204114
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 Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/29/2013N36156000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204114s000lbl.pdf 5/29/2013
AP05/29/2013N36160000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204114Orig1s000ltr.pdf 5/30/2013
AP05/29/2013N36236000Office Director Memo  http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204114Orig1s000ODMemo.pdf 6/7/2013
AP05/29/2013N36237000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204114Orig1s000SumR.pdf 6/7/2013
AP05/29/2013N36503000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204114Orig1s000TOC.cfm 7/8/2013
AP01/8/2014SE138234001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204114s001lbl.pdf 1/9/2014
AP01/8/2014SE138240001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204114Orig1s001ltr.pdf 1/10/2014
AP08/13/2014SCM       
AP09/26/2014SCM       
AP011/20/2015S44549004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204114s004lbl.pdf 11/20/2015
AP011/20/2015S44563004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204114Orig1s004ltr.pdf 11/23/2015




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