Back to FDA Applications sponsored by MALLINKRODT NUCLEAR

FDA Drug Application 016517 by MALLINKRODT NUCLEAR

Application Number016517
Application Type New Drug Application
Sponsor ApplicantMALLINKRODT NUCLEAR
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
AP08/20/1971N       
AP01/16/1976SFP       
AP05/3/1977SLR       
AP07/29/1977SCM       
AP08/23/1977SCM       
AP07/12/1983SPD       
AP02/3/2012SLR31666009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016517s009lbl.pdf 2/6/2012
AP02/3/2012SLR31706009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016517s009ltr.pdf 2/7/2012
AP03/20/2014SLR38869011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016517Orig1s011ltr.pdf 3/21/2014
AP03/20/2014SLR38887011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016517s011lbl.pdf 3/25/2014
AP010/23/2014SCM       
AP010/20/2015SLR44240013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016517Orig1s013ltr.pdf 10/21/2015
AP010/20/2015SLR44254013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016517s013lbl.pdf 10/22/2015




Back to FDA Applications sponsored by MALLINKRODT NUCLEAR

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.