Back to FDA Applications sponsored by FRESENIUS KABI USA

FDA Drug Application 087329 by FRESENIUS KABI USA

Application Number087329
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
AP08/11/1981N       
AP010/13/1982SC       
AP010/2/1984SC       
AP010/2/1984SC       
AP012/13/1984SC       
AP03/20/1990SL       
AP09/23/1994SCI       
AP06/23/1993SLI       
AP07/5/1996SC       
AP06/24/1996SC       
AP012/5/2002SCB       
AP06/4/2014SLR39507019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/087329Orig1s019ltr.pdf 6/11/2014
AP06/4/2014SLR39652019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087329Orig1s019lbl.pdf 6/24/2014
AP09/25/2014SLR40827020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/087329Orig1s020ltr.pdf 10/21/2014
AP09/25/2014SLR40904020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087329Orig1s020lbl.pdf 10/30/2014




Back to FDA Applications sponsored by FRESENIUS KABI USA

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.