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FDA Drug Application 021475 by MALLINCKRODT

Application Number021475
Application Type New Drug Application
Sponsor ApplicantMALLINCKRODT
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/15/2003N5365000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21475_methylin_lbl.pdf 4/17/2003
AP04/15/2003N14530000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021475s000_MethylinTOC.cfm 7/25/2006
AP04/15/2003N24015000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088639.pdf 11/19/2009
AP04/15/2003N31033000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm 12/20/2011
AP08/10/2006SLR14663002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021475s002,021419s003lbl.pdf 8/11/2006
AP08/10/2006SLR14703002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021475s002, 021419s003LTR.pdf 8/14/2006
AP06/7/2007SLR16753004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021419s001,021475s004lbl.pdf 6/12/2007
AP06/7/2007SLR16764004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021419s001,021475s004ltr.pdf 6/14/2007
AP010/18/2010SLR26687005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021475s005lbl.pdf 10/18/2010
AP010/18/2010SLR26720005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021419s004,021475s005ltr.pdf 10/20/2010
AP06/14/2013SLR36301006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021475s006lbl.pdf 6/18/2013
AP06/14/2013SLR36333006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021419Orig1s006,021475Orig1s006ltr.pdf 6/18/2013
AP012/12/2013SLR38054007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021475s007lbl.pdf 12/17/2013
AP012/12/2013SLR38158007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021419Orig1s007,021475Orig1s007ltr.pdf 12/24/2013
AP09/15/2014SCM       
AP04/17/2015SLR42582009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021475Orig1s009,021419Orig1s009ltr.pdf 4/20/2015
AP04/17/2015SLR42612009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021419s009,021475s009lbl.pdf 4/21/2015




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