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FDA Drug Application 022581 by FRESENIUS MEDCL

Application Number022581
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 Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/19/2011N28588000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022581s000ltr.pdf 4/20/2011
AP04/19/2011N28596000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022581s000lbl.pdf 4/21/2011
AP04/19/2011N30352000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022581_phoslyra_toc.cfm 10/20/2011
AP04/19/2011N30353000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022581Orig1s000SumR.pdf 10/20/2011
AP05/16/2014SCM       
AP01/17/2014SCM       
AP08/27/2014SCM       
AP04/30/2015SLR42713006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022581Orig1s006ltr.pdf 5/4/2015
AP04/30/2015SLR42725006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022581s006lbl.pdf 5/4/2015




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