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FDA Drug Application 020363 by NOVARTIS

Application Number020363
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
AP06/29/1994N       
AP012/27/1994SCM       
AP012/11/1995SE1       
AP07/29/1996SLR       
AP09/8/1995SCM       
AP07/29/1996SLR       
AP04/26/1996SLR       
AP01/13/1997SLR       
AP06/12/1998SLR171010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20363S14ltr.pdf 6/12/1998
AP01/31/1997SCM       
AP09/17/1997SE1       
AP07/15/1997SLR       
AP06/12/1998SE1463014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20363S14ltr.pdf 6/12/1998
AP03/26/1998SCS       
AP06/12/1998SLR752016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20363S14ltr.pdf 6/12/1998
AP02/2/1999SCS       
AP03/29/2001SLR1838019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20363S19LTR.PDF 3/29/2001
AP03/29/2001SLR1839019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20363S19LBL.PDF 3/29/2001
AP03/29/2001SLR8347019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-363S-019_review.pdf 4/14/2004
AP08/6/2002SCM       
AP02/22/2006SLR13665026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020363s026lbl.pdf 2/28/2006
AP02/22/2006SLR13685026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020363s026ltr.pdf 3/1/2006
AP07/28/2006SE214578027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020363s027s028lbl.pdf 8/4/2006
AP07/28/2006SE214608027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020363s027, 020363s028LTR.pdf 8/4/2006
AP07/28/2006SE114609028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020363s027, 020363s028LTR.pdf 8/4/2006
AP07/28/2006SE114579028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020363s027s028lbl.pdf 8/4/2006
AP012/22/2008SLR21410034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020363s034ltr.pdf 12/24/2008
AP012/22/2008SLR21456034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020363s034lbl.pdf 1/2/2009
AP012/24/2009SE824386036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020363s036ltr.pdf 12/31/2009
AP012/24/2009SE824496036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020363s036lbl.pdf 1/12/2010
AP01/31/2011SE827682037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020363s037lbl.pdf 1/31/2011
AP01/31/2011SE827708037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020363s037ltr.pdf 2/4/2011
AP02/9/2012SE831739038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020363s038s040lbl.pdf 2/10/2012
AP02/9/2012SE831744038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020363s038,s040ltr.pdf 2/13/2012
AP02/9/2012SLR31745040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020363s038,s040ltr.pdf 2/13/2012
AP02/9/2012SLR31740040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020363s038s040lbl.pdf 2/10/2012
AP06/25/2014SCM       
AP04/24/2013SLR35849042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020363Orig1s042ltr.pdf 4/25/2013
AP04/24/2013SLR35877042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020363s042lbl.pdf 4/30/2013
AP05/14/2015SCM       
AP010/19/2015SCM       
AP09/10/2015SCM       
AP09/16/2016SLR47100047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020363Orig1s047ltr.pdf 9/20/2016
AP09/16/2016SLR47120047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020363s047lbl.pdf 9/20/2016




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