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FDA Drug Application 018704 by NOVARTIS

Application Number018704
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/30/1984N       
AP011/20/1984SCE       
AP05/13/1985SCP       
AP02/4/1988SCM       
AP06/14/1990SLR       
AP01/19/1995SCP       
AP02/28/1996SCS       
AP010/20/1998SCM       
AP010/22/1998SCM       
AP04/15/1999SCM       
AP04/15/1999SCM       
AP05/10/2000SCM       
AP07/30/2001SCM       
AP01/15/2002SCM       
AP04/29/2002SCM       
AP09/12/2003SLR6668015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18704slr015,17963slr058ltr.pdf 9/25/2003
AP09/5/2006SLR14847018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018704s018, 017963s059_ltr.pdf 9/18/2006
AP01/8/2008SLR18798020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017963s061,018704s020ltr.pdf 1/9/2008
AP07/24/2008SLR20310021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017963s062,018704s021lbl.pdf 7/29/2008
AP07/24/2008SLR20324021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017963s062,018704s021ltr.pdf 7/30/2008
AP011/20/2009SLR24099023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017963s063,018704s023lbl.pdf 11/23/2009
AP011/20/2009SLR24454023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017963s063,018704s023ltr.pdf 1/6/2010
AP012/21/2012SLR34761025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018704Orig1s025ltr.pdf 12/26/2012
AP012/21/2012SLR34815025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018704s025lbl.pdf 1/2/2013
AP03/14/2013SLR35456026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018704Orig1s026ltr.pdf 3/15/2013
AP03/14/2013SLR35459026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018704s026lbl.pdf 3/15/2013




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