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FDA Drug Application 206910 by NOVARTIS PHARMS CORP

Application Number206910
Application Type New Drug Application
Sponsor ApplicantNOVARTIS PHARMS CORP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/30/2015N42414000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206910Orig1s000ltr.pdf 4/3/2015
AP03/30/2015N42452000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206910s000lbl.pdf 4/7/2015
AP03/30/2015N46722000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206910Orig1s000TOC.cfm 8/4/2016
AP010/22/2015SLR44297001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206910Orig1s001,s003ltr.pdf 10/26/2015
AP010/22/2015SLR44292001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206910s001s003lbl.pdf 10/26/2015
AP011/6/2015SCM       
AP010/22/2015SLR44293003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206910s001s003lbl.pdf 10/26/2015
AP010/22/2015SLR44298003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206910Orig1s001,s003ltr.pdf 10/26/2015
AP08/12/2016SLR46779004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206910Orig1s004ltr.pdf 8/15/2016
AP08/12/2016SLR46793004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206910s004lbl.pdf 8/17/2016




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