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FDA Drug Application 016775 by NOVARTIS

Application Number016775
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/27/1970N       
AP03/31/1975SCS       
AP03/31/1975SLR       
AP08/19/1977SCP       
AP08/5/1977SCP       
AP08/30/1979SCP       
AP01/16/1980SCM       
AP012/10/1980SLR       
AP06/19/1981SCM       
AP011/16/1982SCS       
AP011/5/1982SLR       
AP010/18/1982SCS       
AP06/26/1984SCS       
AP06/10/1986SCS       
AP011/24/1986SCS       
AP04/23/1987SCS       
AP05/26/1987SCS       
AP08/20/1987SCS       
AP05/10/1989SCS       
AP011/21/1988SCM       
AP08/15/1989SCM       
AP09/22/1989SCM       
AP08/1/1994SCS       
AP03/14/1997SCS       
AP09/6/2000SLR       
AP03/15/2001SLR3238041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16997S41LTR.PDF 3/15/2001
AP03/15/2001SLR3239041   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/16-774S073.pdf 2/5/2003
AP03/28/2001SCM       




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