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FDA Drug Application 020665 by NOVARTIS

Application Number020665
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/23/1996N25038000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020665_s000.pdf 3/16/2010
AP012/23/1996N31206000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm 12/22/2011
AP06/27/1997SLR       
AP08/15/1997SCM       
AP08/18/1998SCM       
AP011/27/1998SLR6446004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020665s004_diovan_toc.cfm 8/8/2003
AP02/18/1999SCM       
AP04/28/1999SCP       
AP012/3/1999SCM       
AP011/29/1999SLR       
AP02/23/2000SCM       
AP04/18/2000SCS       
AP05/10/2000SCM       
AP07/27/2000SCM       
AP011/2/2000SCM       
AP010/23/2001SCM       
AP08/14/2002SE11701016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20665se1-016,21283se1-001ltr.pdf 8/14/2002
AP08/14/2002SE11702016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20665s16lbl.pdf 8/14/2002
AP08/14/2002SE14677016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-283s001_Diovan.cfm 8/14/2002
AP04/29/2002SCM       
AP011/6/2002SCS       
AP08/1/2002SCM       
AP010/29/2013SLR37614033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020665Orig1s033ltr.pdf 10/30/2013
AP010/29/2013SLR37646033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020665s033lbl.pdf 10/31/2013
AP03/17/2014SLR38810034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020665Orig1s034,s035ltr.pdf 3/19/2014
AP03/17/2014SLR38833034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020665s034s035lbl.pdf 3/19/2014
AP03/17/2014SLR38834035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020665s034s035lbl.pdf 3/19/2014
AP03/17/2014SLR38811035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020665Orig1s034,s035ltr.pdf 3/19/2014
AP02/16/2015SCM       
AP09/24/2014SLR40614037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020665Orig1s037ltr.pdf 9/26/2014
AP09/24/2014SLR40635037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020665s037lbl.pdf 9/26/2014
AP07/27/2015SLR43506038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020665Orig1s038ltr.pdf 7/28/2015
AP07/27/2015SLR43534038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020665s038lbl.pdf 7/30/2015




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