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FDA Drug Application 203629 by FRESENIUS KABI USA

Application Number203629
Application Type New Drug Application
Sponsor ApplicantFRESENIUS KABI USA
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
AP01/8/2015N41620000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203629Orig1s000ltr.pdf 1/13/2015
AP01/8/2015N41734000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203629s000lbl.pdf 1/29/2015
AP01/8/2015N43454000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203629Orig1s000TOC.cfm 7/22/2015
AP01/8/2015N43455000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203629Orig1s000SumR.pdf 7/22/2015
AP07/31/2015SCM       




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