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FDA Drug Application 021160 by FRESENIUS MEDCL

Application Number021160
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 Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/2/2001N1357000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21160ltr.pdf 4/2/2001
AP04/2/2001N1358000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21160lbl.pdf 4/2/2001
AP04/2/2001N3477000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021160_Phoslo.cfm 4/2/2001
AP02/2/2004SLR7768001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19976slr006,21160slr001ltr.pdf 3/2/2004
AP03/29/2011SLR28411015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021160s015ltr.pdf 3/31/2011
AP02/21/2013SCM       
AP09/12/2013SCM       
AP04/29/2015SCM       
AP05/27/2014SCM       
AP04/12/2016SCM       
AP03/24/2016SCM       
AP06/22/2016SCM       




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