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FDA Drug Application 071258 by APOTEX

Application Number071258
Application Type Abbreviated New Drug Application
Sponsor ApplicantAPOTEX
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
AP03/25/1987N       
AP011/20/1987SC       
AP010/26/1988SC       
AP08/6/1991SL       
AP09/23/1991SL       
AP04/3/1992SC       
AP04/3/1992SC       
AP010/11/1994SC       
AP012/23/1994SC       
AP09/18/1996SL       
AP05/6/1997SC       
AP09/25/1998SC       
AP012/1/1998SC       
AP03/11/1999SC       
AP05/20/1999SC       
AP07/7/2000SCS       
AP012/21/1999SCB       
AP09/13/2000SL       
AP011/19/2013SLR37861040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/071258Orig1s040,071196Orig1s063ltr.pdf 11/20/2013
AP011/19/2013SLR37869040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/071258Orig1s040, 071196Orig1s063lbl.pdf 11/20/2013




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