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FDA Drug Application 200656 by FRESENIUS KABI USA

Application Number200656
Application Type New Drug Application
Sponsor ApplicantFRESENIUS KABI USA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/25/2014N40314000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200656s000lbl.pdf 8/26/2014
AP08/25/2014N40324000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200656Orig1s000ltr.pdf 8/27/2014
AP08/25/2014N45325000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/200656Orig1s000TOC.cfm 3/2/2016
AP08/25/2014N45326000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/200656Orig1s000SumR.pdf 3/2/2016
AP04/12/2016SLR45669001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200656s001lbl.pdf 4/13/2016
AP04/12/2016SLR45682001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200656Orig1s001ltr.pdf 4/14/2016
AP04/11/2016SCM       
AP06/9/2016SCM       




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