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FDA Drug Application 019976 by FRESENIUS MEDCL

Application Number019976
Application Type New Drug Application
Sponsor ApplicantFRESENIUS MEDCL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/10/1990N       
AP02/22/1993SCS       
AP07/27/1992SLR       
AP09/13/1995SCM       
AP05/7/1996SCM       
AP011/4/2002SLR3476005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19976slr005ltr.pdf 11/4/2002
AP02/2/2004SLR7767006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19976slr006,21160slr001ltr.pdf 3/2/2004
AP03/9/2016SCM       




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