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FDA Drug Application 103764 by NOVARTIS

Application Number103764
Application Type Biologic License Application
Sponsor ApplicantNOVARTIS
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
AP05/12/1998N81450000   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093359.htm 3/29/2004
AP05/12/1998N81460000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/basnov051298lb.pdf 3/29/2004
AP05/12/1998N81470000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/basnov051298L.htm 3/29/2004
AP03/23/2001S81505003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/basnova032301L.htm 3/29/2004
AP03/23/2001S81515003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/basnova032301LB.pdf 3/29/2004
AP01/2/2003S81485037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/basnov010203L.htm 3/29/2004
AP01/2/2003S81495037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/basnov010203LB.htm 3/29/2004
AP011/14/2003S70465040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103764-5040ltr.pdf 12/4/2003




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