Back to FDA Applications sponsored by FRESENIUS KABI USA

FDA Drug Application 078096 by FRESENIUS KABI USA

Application Number078096
Application Type Abbreviated New Drug Application
Sponsor ApplicantFRESENIUS KABI USA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
TA08/30/2007TA       
TA11/8/2008TA       
AP26/30/2008N       
AP09/18/2014SLR40579005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/078096Orig1s005,078090Orig1s005,078522Orig1s005lbl.pdf 9/23/2014
AP09/18/2014SLR40589005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/078096Orig1s005,078090Orig1s005,078522Orig1s005ltr.pdf 9/24/2014




Back to FDA Applications sponsored by FRESENIUS KABI USA