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FDA Drug Application 125504 by NOVARTIS PHARMS CORP

Application Number125504
Application Type Biologic License Application
Sponsor ApplicantNOVARTIS PHARMS CORP
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
AP01/21/2015N41662000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125504s000lbl.pdf 1/22/2015
AP01/21/2015N41671000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125504Orig1s000ltr.pdf 1/23/2015
AP01/21/2015N41868000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125504Orig1s000TOC.cfm 2/19/2015
AP01/21/2015N41869000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125504Orig1s000SumR.pdf 2/19/2015
AP01/15/2016SE844987001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125504Orig1s001,s002ltr.pdf 1/20/2016
AP01/15/2016SE845034001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125504s001s002lbl.pdf 1/26/2016
AP01/15/2016SE845035002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125504s001s002lbl.pdf 1/26/2016
AP01/15/2016SE844988002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125504Orig1s001,s002ltr.pdf 1/20/2016




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