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FDA Drug Application 016774 by NOVARTIS

Application Number016774
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
AP02/27/1970N       
AP01/30/1975SCS       
AP06/7/1974SCS       
AP03/31/1975SCS       
AP05/6/1975SCS       
AP07/1/1975SCS       
AP012/2/1975SCS       
AP07/16/1976SCP       
AP08/3/1976SCP       
AP05/25/1976SCF       
AP09/15/1976SDS       
AP01/24/1978SCP       
AP06/3/1977SCS       
AP06/3/1977SCS       
AP012/8/1978SCP       
AP06/12/1978SCF       
AP08/30/1979SCP       
AP04/4/1979SCM       
AP01/16/1980SCM       
AP03/7/1980SCP       
AP012/10/1980SLR       
AP03/24/1981SCF       
AP06/22/1981SCM       
AP01/19/1983SCS       
AP011/5/1982SLR       
AP010/17/1986SCS       
AP03/14/1984SCP       
AP05/8/1985SCM       
AP010/23/1985SCF       
AP03/24/1986SCP       
AP04/23/1987SCS       
AP05/26/1987SCS       
AP08/20/1987SCS       
AP03/14/1990SCP       
AP05/10/1989SCS       
AP08/15/1989SCM       
AP011/3/1989SCP       
AP07/1/1994SCS       
AP011/30/1990SCP       
AP08/1/1994SCP       
AP010/17/1995SCS       
AP011/22/1995SCM       
AP03/14/1997SCS       
AP09/6/2000SLR       
AP03/15/2001SLR3240073   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/16-774S073.pdf 2/5/2003
AP03/15/2001SLR3241073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16997S41LTR.PDF 3/15/2001
AP07/6/2001SCM       
AP03/28/2001SCM       




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