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FDA Drug Application 019942 by FRESENIUS

Application Number019942
Application Type New Drug Application
Sponsor ApplicantFRESENIUS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/30/1993N19231000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019942_ORIGINAL_APPROVAL_PACKAGE.pdf 2/19/2008
AP04/29/1997SCS       
AP03/18/1999SCM       
AP07/21/1999SCS       
AP09/27/2000SCS       
AP08/22/2001SCM       
AP04/16/2004SCS8385010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17643scs070,18449scs037,19942scs010ltr.pdf 4/20/2004




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