Back to FDA Applications sponsored by MALLINCKRODT INC

FDA Drug Application 204031 by MALLINCKRODT INC

Application Number204031
Application Type New Drug Application
Sponsor ApplicantMALLINCKRODT INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/11/2014N38780000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204031Orig1s000ltr.pdf 3/13/2014
AP03/11/2014N38792000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204031s000lbl.pdf 3/13/2014
AP03/11/2014N39092000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204031Orig1s000TOC.cfm 4/18/2014
AP03/12/2015SLR42136001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204031Orig2s001ltr.pdf 3/13/2015
AP03/12/2015SLR42178001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204031s001lbl.pdf 3/17/2015
AP01/26/2015SCM       




Back to FDA Applications sponsored by MALLINCKRODT INC