Back to FDA Applications sponsored by MYLAN PHARMS INC

FDA Drug Application 078857 by MYLAN PHARMS INC

Application Number078857
Application Type Abbreviated New Drug Application
Sponsor ApplicantMYLAN PHARMS INC
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
TA04/29/2011TA39408000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/078857Orig2s000ltr.pdf 6/2/2014
TA15/30/2014TA39408000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/078857Orig2s000ltr.pdf 6/2/2014
AP22/11/2015N39408000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/078857Orig2s000ltr.pdf 6/2/2014
TA04/29/2011TA42480000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/078857Orig2s000ltr.pdf 6/2/2014
TA15/30/2014TA42480000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/078857Orig2s000ltr.pdf 6/2/2014
AP22/11/2015N42480000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/078857Orig2s000ltr.pdf 6/2/2014




Back to FDA Applications sponsored by MYLAN PHARMS INC

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.