Back to FDA Applications sponsored by ACCORD HLTHCARE

FDA Drug Application 201195 by ACCORD HLTHCARE

Application Number201195
Application Type New Drug Application
Sponsor ApplicantACCORD HLTHCARE
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
AP06/8/2011N29108000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201195s000lbl.pdf 6/10/2011
AP06/8/2011N29112000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201195s000ltr.pdf 6/13/2011
AP06/8/2011N31728000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201195_docetaxel_toc.cfm 2/10/2012
AP06/8/2011N31729000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201195Orig1s000SumR.pdf 2/10/2012
AP04/5/2013SCM35649004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201195s004lbl.pdf 4/9/2013
AP011/6/2013SCM       
AP07/3/2014SLR39780006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201195Orig1s006ltr.pdf 7/8/2014
AP07/3/2014SLR39812006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201195s006lbl.pdf 7/8/2014
AP05/27/2016SCM       
AP010/21/2015SCM       
AP07/26/2016SLR46651009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201195s009lbl.pdf 7/27/2016
AP07/26/2016SLR46671009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201195Orig1s009ltr.pdf 7/28/2016




Back to FDA Applications sponsored by ACCORD HLTHCARE

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.