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FDA Drug Application 018285 by NOVARTIS

Application Number018285
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
AP09/3/1982N       
AP011/5/1982SLR       
AP01/11/1983SCP       
AP06/2/1983SES       
AP07/20/1984SCS       
AP03/21/1985SLR       
AP07/16/1985SCM       
AP02/20/1986SCM       
AP02/20/1986SCS       
AP06/10/1987SCS       
AP07/8/1986SLR       
AP07/23/1987SLR       
AP010/27/1988SCS       
AP010/26/1989SCP       
AP05/1/1989SLR       
AP010/23/1989SCP       
AP01/11/1990SLR       
AP01/10/1990SCS       
AP012/4/1991SCP       
AP09/3/1991SCS       
AP08/19/1992SLR       
AP01/14/1992SCS       
AP09/21/1992SCP       
AP012/15/1993SCS       
AP03/7/1995SCS       
AP011/2/1995SCM       
AP09/9/1997SCS       
AP010/15/1998SCS       
AP012/14/1998SCM       
AP02/24/1999SCM       
AP04/28/1999SCP       
AP04/2/2001SCM       
AP010/27/2007SLR18316034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018285s034lbl.pdf 11/7/2007
AP010/27/2007SLR18390034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018285s034ltr.pdf 11/8/2007




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