Back to FDA Applications sponsored by MALLINCKRODT INC

FDA Drug Application 022462 by MALLINCKRODT INC

Application Number022462
Application Type New Drug Application
Sponsor ApplicantMALLINCKRODT INC
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
AP011/19/2010N27016000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022462s000lbl.pdf 11/26/2010
AP011/19/2010N27059000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022462s000ltr.pdf 11/29/2010
AP011/19/2010N28092000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022462Orig1s000TOC.cfm 3/7/2011
AP011/19/2010N28093000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022462Orig1s000SumR.pdf 3/7/2011
AP06/22/2012SCM       
AP01/17/2013SCM       
AP02/11/2015SLR41835008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022462Orig1s008ltr.pdf 2/12/2015
AP02/11/2015SLR41836008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022462s008lbl.pdf 2/12/2015




Back to FDA Applications sponsored by MALLINCKRODT 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.