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FDA Drug Application 125319 by NOVARTIS PHARMS

Application Number125319
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
AP06/17/2009N22846000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125319s000lbl.pdf 6/29/2009
AP06/17/2009N22854000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125319s000ltr.pdf 6/30/2009
AP06/17/2009N23228000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125319s000TOC.cfm 8/26/2009
AP06/17/2009N23229000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125319s000_SumR.pdf 8/26/2009
AP06/17/2009N36071000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM352352.pdf 5/15/2013
AP03/30/2012SLR32334047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125319s047lbl.pdf 4/2/2012
AP03/30/2012SLR32341047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125319s047ltr.pdf 4/2/2012
AP010/11/2012SLR34063054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125319s0054.pdf 10/12/2012
AP010/11/2012SLR34095054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125319Orig1s054ltr.pdf 10/15/2012
AP05/9/2013SE836035062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125319Orig1s062ltr_repl.pdf 5/13/2013
AP05/9/2013SE836045062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125319s062lbl.pdf 5/13/2013
AP010/16/2014SLR40838081   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125319Orig1s081ltr.pdf 10/21/2014
AP010/16/2014SLR40850081   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125319s081lbl.pdf 10/21/2014
AP07/21/2016SE846599084   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125319s084lbl.pdf 7/22/2016
AP07/21/2016SE846609084   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125319Orig1s084ltr.pdf 7/26/2016
AP09/23/2016SE847168085   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125319Orig1s085,s086,s087ltr.pdf 9/26/2016
AP09/23/2016SE847178085   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/BLA125319_858687lbl.pdf 9/27/2016
AP09/23/2016SE847179086   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/BLA125319_858687lbl.pdf 9/27/2016
AP09/23/2016SE847167086   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125319Orig1s085,s086,s087ltr.pdf 9/26/2016
AP09/23/2016SE847180087   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/BLA125319_858687lbl.pdf 9/27/2016
AP09/23/2016SE847166087   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125319Orig1s085,s086,s087ltr.pdf 9/26/2016




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