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FDA Drug Application 083082 by HIKMA PHARMS LLC

Application Number083082
Application Type Abbreviated New Drug Application
Sponsor ApplicantHIKMA PHARMS LLC
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
AP07/9/1975N       
AP07/20/1989SB       
AP04/2/1991SC       
AP09/5/1997SC       
AP09/5/1997SC       
AP09/5/1997SC       
AP09/5/1997SC       
AP09/5/1997SC       
AP010/1/1998SC       
AP05/24/2000SC       
AP05/24/2000SL       
AP05/24/2000SC       
AP09/17/1999SCQ       
AP09/17/1999SL       
AP09/17/1999SC       
AP05/24/2000SL       
AP05/24/2000SCD       
AP05/24/2000SCE       
AP011/30/2000SCA       
AP011/30/2000SCE       
AP011/30/2000SL       
AP07/11/2001SCS       
AP011/10/2009SLR23878050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/083082s050lbl.pdf 11/16/2009




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