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FDA Drug Application 201688 by NOVARTIS

Application Number201688
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/22/2013N35520000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201688s000lbl.pdf 3/26/2013
AP03/22/2013N35545000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201688Orig1s000ltr.pdf 3/26/2013
AP03/22/2013N38690000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201688Orig1s000TOC.cfm 3/6/2014
AP03/22/2013N38691000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201688Orig1s000SumR.pdf 3/6/2014
AP01/7/2014SCM       
AP04/25/2014SLR39150002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201688Orig1s002ltr.pdf 4/28/2014
AP04/25/2014SLR39153002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201688s002lbl.pdf 4/28/2014
AP09/30/2014SCM       
AP011/19/2014SLR41035004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201688Orig1s004ltr.pdf 11/20/2014
AP011/19/2014SLR41062004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201688s004lbl.pdf 11/20/2014
AP09/11/2015SCM       
AP010/2/2015SLR44117006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201688Orig1s006ltr.pdf 10/6/2015
AP010/2/2015SLR44171006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201688s006lbl.pdf 10/8/2015
AP01/6/2016SCM       




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