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FDA Drug Application 202806 by NOVARTIS PHARMS CORP

Application Number202806
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
AP05/29/2013N36155000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202806s000lbl.pdf 5/29/2013
AP05/29/2013N36157000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM354532.pdf 5/30/2013
AP05/29/2013N36161000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202806Orig1s000ltr.pdf 5/30/2013
AP05/29/2013N36238000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202806Orig1s000SumR.pdf 6/7/2013
AP05/29/2013N36239000Office Director Memo  http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202806Orig1s000ODMemo.pdf 6/7/2013
AP05/29/2013N36459000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202806Orig1s000TOC.cfm 7/5/2013
AP012/26/2013SLR38191001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202806s001lbl.pdf 12/30/2013
AP012/26/2013SLR38195001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202806Orig1s001ltr.pdf 12/31/2013
AP01/9/2014SE138246002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202806s002lbl.pdf 1/10/2014
AP01/9/2014SE138260002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202806Orig1s002ltr.pdf 1/14/2014
AP08/25/2014SCM       
AP011/20/2015S44548004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202806s004lbl.pdf 11/20/2015
AP011/20/2015S44562004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202806Orig1s004ltr.pdf 11/23/2015
AP06/16/2016SLR46381005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202806s005lbl.pdf 6/21/2016




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