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FDA Drug Application 020364 by NOVARTIS

Application Number020364
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/3/1995N       
AP07/6/1995SCP       
AP04/29/1996SLR       
AP08/15/1995SCS       
AP011/2/1995SCM       
AP011/17/1995SCE       
AP011/6/1995SCS       
AP03/14/1997SLR4299007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20364S007_Latrel.pdf 3/14/1997
AP06/16/1999SLR2987008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-364S008_Lotrel.cfm 8/21/2001
AP06/16/1999SLR4798008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-364-S008_Lotrel_Approv.pdf 6/16/1999
AP06/16/1999SLR4799008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-364-S008_Lotrel_prntlbl.pdf 6/16/1999
AP07/21/1998SCM       
AP02/18/1999SCM       
AP04/28/1999SCP       
AP05/10/2000SCM       
AP011/2/2000SCM       
AP08/29/2003SLR6619014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20364slr014ltr.pdf 9/9/2003
AP011/30/2001SCS       
AP06/20/2002SE82988016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20364s016LTR.pdf 6/20/2002
AP06/20/2002SE82989016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/020364-S016_Lotrel_lbl.pdf 6/20/2002
AP06/20/2002SE82990016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020364-s016_Lotrel.cfm 11/22/2002
AP012/12/2001SCS       
AP04/29/2002SCM       
AP09/20/2002SCM       
AP010/25/2002SCS       
AP04/11/2006SE213892023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020364s023lbl.pdf 4/12/2006
AP04/11/2006SE213916023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020364s023ltr.pdf 4/13/2006
AP07/2/2004SLR9708024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20364slr024ltr.pdf 7/6/2004
AP07/2/2004SLR9716024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20364slr024_lotrel_lbl.pdf 7/7/2004
AP08/11/2004SLR10010028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20364s028ltr.pdf 8/12/2004
AP02/23/2007SLR15954036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020364s036ltr.pdf 3/6/2007
AP08/31/2007SCS17737039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020364s039lbl.pdf 9/4/2007
AP08/31/2007SCS17762039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020364s039ltr.pdf 9/6/2007
AP010/28/2009SLR23699046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020364s046lbl.pdf 10/30/2009
AP010/28/2009SLR23966046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020364s046ltr.pdf 11/19/2009
AP03/29/2010SLR25182047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020364s047ltr.pdf 4/2/2010
AP03/29/2010SLR25200047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020364s047lbl.pdf 4/4/2010
AP012/22/2009SCM24393048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020364s048lbl.pdf 1/4/2010
AP012/22/2009SCM24411048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020364s048ltr.pdf 1/5/2010
AP01/4/2011SLR27459050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020364s050lbl.pdf 1/5/2011
AP01/4/2011SLR27474050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020364s050ltr.pdf 1/7/2011
AP06/20/2011SLR29351052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020364s052ltr.pdf 6/29/2011
AP06/20/2011SLR29455052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020364s052lbl.pdf 7/7/2011
AP010/28/2011SLR30441054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020364s054ltr.pdf 10/31/2011
AP010/28/2011SLR30447054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020364s054lbl.pdf 11/1/2011
AP01/19/2012SLR31438055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020364s055ltr.pdf 1/23/2012
AP01/19/2012SLR31451055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020364s055lbl.pdf 1/23/2012
AP010/5/2012SLR34010056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020364s056s057lbl.pdf 10/9/2012
AP010/5/2012SLR34020056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020364Orig1s056,s057ltr.pdf 10/10/2012
AP010/5/2012SLR34011057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020364s056s057lbl.pdf 10/9/2012
AP010/5/2012SLR34021057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020364Orig1s056,s057ltr.pdf 10/10/2012
AP012/31/2014SLR41446058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020364Orig1s058ltr.pdf 12/30/2014
AP012/31/2014SLR41490058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020364s058lbl.pdf 1/5/2015
AP06/16/2015SCM       
AP04/22/2015SLR42639060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020364Orig1s060ltr.pdf 4/23/2015
AP04/22/2015SLR42651060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020364s060lbl.pdf 4/24/2015
AP05/18/2015SLR42838061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020364Orig1s061ltr.pdf 5/19/2015
AP05/18/2015SLR42865061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020364s061lbl.pdf 5/21/2015
AP02/8/2016SCM       
AP010/14/2016SCM       




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