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FDA Drug Application 201849 by FRESENIUS KABI USA

Application Number201849
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
AP05/8/2015N42800000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201849Orig1s000ltr.pdf 5/13/2015
AP05/8/2015N46152000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/201849Orig1s000TOC.cfm 5/25/2016
AP011/3/2015SCM       
AP012/1/2015SLR44645002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201849Orig1s002ltr.pdf 12/2/2015
AP012/1/2015SLR44652002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201849s002lbl.pdf 12/2/2015
AP011/3/2015SCM       




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