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FDA Drug Application 022450 by MALLINCKRODT IP

Application Number022450
Application Type New Drug Application
Sponsor ApplicantMALLINCKRODT IP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/2/2010N26896000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022450lbl.pdf 11/5/2010
AP011/2/2010N26897000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022450s000ltr.pdf 11/8/2010
AP011/2/2010N28456000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022450_ofirmev_toc.cfm 4/4/2011
AP011/2/2010N28457000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022450Orig1s000SumR.pdf 4/4/2011
AP04/5/2013SCM       
AP04/19/2013SCM       
AP010/18/2013SLR37484005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022450Orig1s005,s006ltr.pdf 10/21/2013
AP010/18/2013SLR37527005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022450s005s006lbl.pdf 10/22/2013
AP010/18/2013SLR37528006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022450s005s006lbl.pdf 10/22/2013
AP010/18/2013SLR37483006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022450Orig1s005,s006ltr.pdf 10/21/2013
AP09/4/2016SCM       




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