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FDA Drug Application 204223 by FRESENIUS KABI USA

Application Number204223
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
AP010/30/2013N37641000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204223s000lbl.pdf 10/31/2013
AP010/30/2013N37700000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204223Orig1s000ltr.pdf 11/6/2013
AP010/30/2013N38698000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204223Orig1s000TOC.cfm 3/6/2014
AP010/30/2013N38699000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204223Orig1s000SumR.pdf 3/6/2014
AP06/23/2014SCM       
AP011/16/2014SCM       
AP03/3/2015SCM       




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