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FDA Drug Application 203985 by NOVARTIS PHARM

Application Number203985
Application Type New Drug Application
Sponsor ApplicantNOVARTIS PHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/29/2012N33589000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203985s000lbl.pdf 8/29/2012
AP08/29/2012N33603000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203985Orig1s000ltr.pdf 8/31/2012
AP08/29/2012N37780000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203985_afinitor_toc.cfm 11/12/2013
AP08/29/2012N37781000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203985Orig1s000SumR.pdf 11/12/2013
AP03/26/2013SCM       
AP02/20/2014SLR38551002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf 2/21/2014
AP02/20/2014SLR38561002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s021,023,024,203985Orig1s002,004,005_replace_ltr.pdf 2/21/2014
AP011/6/2013SE837729003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022334Orig1s022,203985Orig1s003ltr.pdf 11/7/2013
AP011/6/2013SE837738003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022334s022lbl.pdf 11/8/2013
AP02/20/2014SLR38552004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf 2/21/2014
AP02/20/2014SLR38562004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s021,023,024,203985Orig1s002,004,005_replace_ltr.pdf 2/21/2014
AP02/20/2014SLR38563005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s021,023,024,203985Orig1s002,004,005_replace_ltr.pdf 2/21/2014
AP02/20/2014SLR38553005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf 2/21/2014
AP07/1/2015SCM       
AP07/1/2014SLR39735007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s025203985s007lbl.pdf 7/2/2014
AP07/1/2014SLR39744007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s025,203985Orig1s007ltr.pdf 7/3/2014
AP01/23/2015SLR41681008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203985Orig1s008ltr.pdf 1/26/2015
AP01/23/2015SLR41733008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203985s008lbl.pdf 1/29/2015
AP08/24/2015SCM       
AP01/29/2016SE845068010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022334Orig1s032,203985Orig1s010ltr.pdf 2/1/2016
AP01/29/2016SE845086010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s032,203985s010lbl.pdf 2/2/2016




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