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FDA Drug Application 020036 by NOVARTIS

Application Number020036
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/31/1991N7025000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/pre96/20-036_apvl_ltr.pdf 12/2/2003
AP010/31/1991N7029000   http://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/20-036_aredia_lbl.pdf 12/2/2003
AP010/31/1991N7470000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020036_aredia_toc.cfm 1/6/2004
AP010/31/1991N18701000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm 1/7/2008
AP05/6/1993SCF7471001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-036s001,002,005_ltr_lbl.pdf 1/6/2004
AP05/6/1993SCS7472002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-036s001,002,005_ltr_lbl.pdf 1/6/2004
AP07/21/1992SLR7474003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-036s003_ltr_lbl.pdf 1/6/2004
AP04/15/1994SE25517004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20036lbl.pdf 4/30/2003
AP04/15/1994SE27475004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-036s004_pkg.pdf 1/6/2004
AP04/15/1994SE210180004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/pre96/20-036s004_ltr.pdf 9/10/2004
AP06/9/1993SLR7473005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-036s001,002,005_ltr_lbl.pdf 1/6/2004
AP04/17/1995SCS       
AP09/21/1994SE1       
AP012/8/1994SCS       
AP09/1/1995SE1       
AP07/16/1996SE1       
AP010/5/1998SCM       
AP09/10/1998SCM       
AP09/22/1998SLR941015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20036s015_Aredia.cfm 9/22/1998
AP09/22/1998SLR4462015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20036s015_Aredia_appltr.pdf 9/22/1998
AP09/22/1998SLR1039016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20036s016.cfm 9/22/1998
AP09/22/1998SLR4463016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20036s016_Aredia_appltr.pdf 9/22/1998
AP04/28/2000SCM       
AP03/31/2000SCS       
AP010/9/2003SLR6812020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20036slr020ltr.pdf 10/16/2003
AP010/9/2003SLR19179020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020036_S020_AREDIA.pdf 2/19/2008
AP03/7/2001SCS       
AP01/3/2002SCM       
AP011/15/2001SCS       
AP08/20/2001SE24460024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20036s24ltr.pdf 8/20/2001
AP08/20/2001SE24461024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20036s24lbl.pdf 8/20/2001
AP08/20/2001SE28750024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-036S024_Aredia.pdf 5/27/2004
AP02/12/2002SCM       
AP07/12/2002SE84459026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20036se8026ltr.pdf 7/12/2002
AP01/9/2004SLR7496028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20036slr028ltr.pdf 1/9/2004
AP01/9/2004SLR17524028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020036_S028_AREDIA.pdf 8/6/2007
AP03/24/2004SLR8121029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20036slr029ltr.pdf 3/28/2004
AP02/2/2005SLR11072030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20036s030ltr.pdf 2/3/2005
AP02/2/2005SLR11081030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20036s030lbl.pdf 2/3/2005
AP02/2/2005SLR21618030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020036_s030_Aredia.pdf 1/12/2009
AP010/11/2005SLR12868031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020036s031ltr.pdf 10/14/2005
AP010/11/2005SLR12879031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020036s031lbl.pdf 10/14/2005
AP011/16/2005SLR13107032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020036s032ltr.pdf 11/18/2005
AP011/16/2005SLR13115032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020036s032lbl.pdf 11/18/2005
AP012/11/2007SLR18656034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020036s034lbl.pdf 12/14/2007
AP012/11/2007SLR18850034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020036s034ltr.pdf 1/9/2008
AP012/12/2008SLR21354035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020036s035ltr.pdf 12/18/2008
AP012/12/2008SLR21480035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020036s035lbl.pdf 1/2/2009
AP04/7/2011SLR28450039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020036s039ltr.pdf 4/4/2011
AP04/7/2011SLR28508039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020036s039lbl.pdf 4/11/2011
AP05/31/2012SLR32816041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020036s041lbl.pdf 6/6/2012
AP05/31/2012SLR32841041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020036s041ltr.pdf 6/7/2012




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