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FDA Drug Application 018123 by HIKMA (MAPLE)

Application Number018123
Application Type New Drug Application
Sponsor ApplicantHIKMA (MAPLE)
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/30/1982N       
AP05/19/1983SLR       
AP05/29/1987SLR       
AP02/24/1988SCS       
AP07/27/1989SCS       
AP011/21/1989SCP       
AP08/8/1989SLR       
AP011/8/1989SLR       
AP07/30/1990SLR       
AP02/22/1994SLR       
AP05/9/1994SLR       
AP06/2/2000SCE       
AP07/19/2002SCS1836014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18123scs014ltr.pdf 7/19/2002




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