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FDA Drug Application 074949 by IVAX SUB TEVA PHARMS

Application Number074949
Application Type Abbreviated New Drug Application
Sponsor ApplicantIVAX SUB TEVA PHARMS
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
AP011/26/1997N2525000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74949ap.pdf 1/26/1998
AP011/26/1997N43878000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=351 9/16/2015
AP03/27/1998SC       
AP04/24/1998SL       
AP012/9/1998SC       
AP012/23/1998SC       
AP01/12/1999SC       
AP07/16/1999SL       
AP02/1/1999SL       
AP012/14/1999SC       
AP012/14/1999SC       
AP012/14/1999SC       
AP07/16/1999SL       
AP012/14/1999SC       
AP01/28/2000SCB       
AP01/28/2000SCA       
AP07/31/2003SCQ       
AP07/31/2003SCQ       
AP09/4/2002SCC       
AP09/12/2001SCD       
AP07/29/2002SCB       
AP04/25/2005S       
AP04/25/2005S       




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