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FDA Drug Application 019678 by MYLAN INSTITUTIONAL

Application Number019678
Application Type New Drug Application
Sponsor ApplicantMYLAN INSTITUTIONAL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/20/1992SCM       
AP04/20/1994SCS       
AP012/26/2000SCM       
AP04/18/2002SCS       
AP012/6/2005SLR13260005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019677s005,019678s005lbl.pdf 12/15/2005
AP012/6/2005SLR13277005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019677s005,019678s005ltr.pdf 12/15/2005




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