Back to FDA Applications sponsored by NOVARTIS

FDA Drug Application 016997 by NOVARTIS

Application Number016997
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
AP01/31/1972N       
AP03/31/1975SCS       
AP03/31/1975SLR       
AP09/2/1975SCS       
AP05/25/1976SCF       
AP05/13/1980SCF       
AP01/16/1980SCM       
AP012/10/1980SLR       
AP05/14/1981SCP       
AP09/13/1982SCM       
AP011/5/1982SLR       
AP05/29/1984SCP       
AP06/10/1986SCS       
AP011/24/1986SCP       
AP011/24/1986SCP       
AP011/24/1986SCP       
AP011/24/1986SCP       
AP01/28/1987SCS       
AP06/9/1987SCP       
AP04/23/1987SCS       
AP06/9/1987SCP       
AP05/26/1987SCS       
AP08/20/1987SCS       
AP05/10/1989SCS       
AP08/15/1989SCM       
AP01/25/1991SCM       
AP03/14/1997SCS       
AP09/6/2000SLR       
AP03/15/2001SLR1611041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16997S41LTR.PDF 3/15/2001
AP03/15/2001SLR3235041   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/16-774S073.pdf 2/5/2003




Back to FDA Applications sponsored by NOVARTIS