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FDA Drug Application 205572 by FRESENIUS KABI USA

Application Number205572
Application Type New Drug Application
Sponsor ApplicantFRESENIUS KABI USA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/3/2015N42474000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205572Orig1s000ltr.pdf 4/8/2015
AP04/3/2015N42493000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205572s000lbl.pdf 4/10/2015
AP04/3/2015N45317000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205572Orig1s000TOC.cfm 3/2/2016
AP04/3/2015N45318000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205572Orig1s000SumR.pdf 3/2/2016
AP03/24/2016SCM       
AP07/26/2016SLR46618002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205572s002lbl.pdf 7/26/2016
AP07/26/2016SLR46633002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205572Orig1s002ltr.pdf 7/26/2016
AP07/26/2016SLR46638002   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM088619.pdf 7/26/2016




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