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FDA Drug Application 018074 by SANDOZ

Application Number018074
Application Type New Drug Application
Sponsor ApplicantSANDOZ
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/16/1979N       
AP010/15/1979SCS       
AP010/15/1979SCS       
AP010/26/1979SCF       
AP011/26/1979SLR       
AP02/1/1980SDS       
AP02/28/1980SDS       
AP08/18/1980SCE       
AP05/5/1981SDS       
AP09/25/1980SCF       
AP02/25/1981SDS       
AP03/23/1981SCM       
AP09/10/1981SCS       
AP09/10/1981SCS       
AP011/19/1982SCS       
AP05/3/1985SCM       
AP04/1/1985SCM       
AP04/25/1994SCM       
AP04/25/1994SCM       
AP02/17/1995SCM       
AP08/30/1995SCP       
AP02/2/1996SCS       
AP09/23/1998SCS       
AP011/3/1998SLR       
AP06/16/1999SLR       
AP011/8/1999SCM       
AP02/10/2012SLR31760034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018074s034ltr.pdf 2/14/2012
AP02/10/2012SLR31875034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018074s034lbl.pdf 2/24/2012




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