Back to FDA Applications sponsored by FRESENIUS KABI USA

FDA Drug Application 201811 by FRESENIUS KABI USA

Application Number201811
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
AP03/23/2015N42263000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201811Orig1s000ltr.pdf 3/25/2015
AP03/23/2015N42532000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201811s000lbl.pdf 4/14/2015
AP03/23/2015N45319000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/201811Orig1s000TOC.cfm 3/2/2016
AP03/23/2015N45320000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/201811Orig1s000SumR.pdf 3/2/2016
AP012/11/2015SLR       
AP05/25/2016SLR46175003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201811Orig1s003ltr.pdf 5/27/2016
AP05/25/2016SLR46213003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201811s003lbl.pdf 6/1/2016




Back to FDA Applications sponsored by FRESENIUS KABI USA