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FDA Drug Application 085128 by TEVA

Application Number085128
Application Type Abbreviated New Drug Application
Sponsor ApplicantTEVA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/22/1980N       
AP06/14/1983SC       
AP011/23/1983SC       
AP03/8/1984SC       
AP03/8/1984SC       
AP03/8/1984SC       
AP07/30/1987SC       
AP012/23/1988SL       
AP05/9/1990SL       
AP012/30/1992SC       
AP05/25/1993SC       
AP05/25/1993SC       
AP04/1/1993SC       
AP05/25/1993SC       
AP05/25/1993SC       
AP05/25/1993SC       
AP05/25/1993SC       
AP05/25/1993SC       
AP05/25/1993SC       
AP08/31/1993SC       
AP08/31/1993SC       
AP09/22/1993SC       
AP02/4/1994SC       
AP09/1/1994SC       
AP09/1/1994SC       
AP09/1/1994SC       
AP01/26/1994SC       
AP01/26/1994SC       
AP01/26/1994SC       
AP01/26/1994SC       
AP01/26/1994SC       
AP01/26/1994SC       
AP011/16/1995SC       
AP03/2/1995SC       
AP010/3/1995SC       
AP010/3/1995SC       
AP010/3/1995SC       
AP02/13/1996SC       
AP01/25/1996SC       
AP01/25/1996SC       
AP01/25/1996SC       
AP05/29/1997SC       
AP05/29/1997SC       
AP05/29/1997SC       
AP05/29/1997SL       
AP08/16/1996SC       
AP012/13/1996SC       
AP011/26/1996SC       
AP05/29/1997SC       
AP012/16/1997SL       
AP03/9/1998SC       
AP011/12/1998SL       
AP07/7/2000SCB       
AP09/5/2000SCA       
AP09/5/2000SL       
AP09/5/2000SCE       
AP010/15/2002SCC       
AP04/16/2012SLR32458065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/085128s065lbl.pdf 4/16/2012




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