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FDA Drug Application 125290 by NOVARTIS PHARMS

Application Number125290
Application Type Biologic License Application
Sponsor ApplicantNOVARTIS PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/14/2009N232110000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125290s0000lbl.pdf 8/20/2009
AP08/14/2009N232190000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125290s0000ltr.pdf 8/25/2009
AP08/14/2009N232720000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM180718.pdf 9/2/2009
AP08/14/2009N253350000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125290_extavia_toc.cfm 4/22/2010
AP08/14/2009N253360000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/0125290s000sumr.pdf 4/22/2010
AP03/18/2012SLR321580033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125290s0033ltr.pdf 3/20/2012
AP03/18/2012SLR321600033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125290s0033mg.pdf 3/20/2012
AP012/22/2014SLR41435029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125290Orig1s029ltr.pdf 12/30/2014
AP05/12/2016SLR46030062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125290Orig1s062ltr.pdf 5/16/2016
AP05/12/2016SLR46039062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125290s062lbl.pdf 5/17/2016
AP012/22/2015S44872063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125290Orig1s063ltr.pdf 12/23/2015
AP012/22/2015S44887063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125290s063lbl.pdf 12/28/2015




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