Back to FDA Applications sponsored by ROXANE

FDA Drug Application 022402 by ROXANE

Application Number022402
Application Type New Drug Application
Sponsor ApplicantROXANE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type Drug already marketed, but without an approved NDA
Therapeutic Potential Standard
Orphan Code 

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/16/2009N23009000 7/22/2009
AP07/16/2009N23067000 7/24/2009
AP07/16/2009N24354000 12/30/2009
AP07/16/2009N24355000 12/30/2009
AP04/17/2012SLR32473003 4/19/2012
AP04/17/2012SLR32484003 4/20/2012
AP05/9/2013SLR36063006 5/14/2013
AP05/9/2013SLR36068006 5/14/2013

Back to FDA Applications sponsored by ROXANE

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.