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FDA Drug Application 016515 by MALLINKRODT NUCLEAR

Application Number016515
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
AP08/18/1971N       
AP06/2/1976SLR       
AP010/27/1977SCS       
AP010/27/1977SLR       
AP07/27/1977SCM       
AP06/7/1988SCF       
AP07/11/1983SPD       
AP02/3/2012SLR31665010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016515s010lbl.pdf 2/6/2012
AP02/3/2012SLR31705010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016515s010ltr.pdf 2/7/2012
AP03/20/2014SLR38868012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016515Orig1s012ltr.pdf 3/21/2014
AP03/20/2014SLR38888012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016515s012lbl.pdf 3/25/2014
AP010/20/2015SLR44239013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016515Orig1s013ltr.pdf 10/21/2015
AP010/20/2015SLR44255013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016515s013lbl.pdf 10/22/2015




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