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FDA Drug Application 021419 by MALLINCKRODT

Application Number021419
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
AP012/19/2002N3570000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21419ltr.pdf 12/19/2002
AP012/19/2002N10471000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-419_Methylin.cfm 10/26/2004
AP012/19/2002N24014000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088640.pdf 11/19/2009
AP012/19/2002N31032000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm 12/20/2011
AP06/7/2007SLR16754001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021419s001,021475s004lbl.pdf 6/12/2007
AP06/7/2007SLR16765001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021419s001,021475s004ltr.pdf 6/14/2007
AP08/10/2006SLR14662003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021475s002,021419s003lbl.pdf 8/11/2006
AP08/10/2006SLR14702003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021475s002, 021419s003LTR.pdf 8/14/2006
AP010/18/2010SLR26688004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021419s004lbl.pdf 10/18/2010
AP010/18/2010SLR26719004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021419s004,021475s005ltr.pdf 10/20/2010
AP06/14/2013SLR36300006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021419s006lbl.pdf 6/18/2013
AP06/14/2013SLR36332006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021419Orig1s006,021475Orig1s006ltr.pdf 6/18/2013
AP012/12/2013SLR38053007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021419s007lbl.pdf 12/17/2013
AP012/12/2013SLR38157007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021419Orig1s007,021475Orig1s007ltr.pdf 12/24/2013
AP09/15/2014SCM       
AP04/17/2015SLR42583009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021475Orig1s009,021419Orig1s009ltr.pdf 4/20/2015
AP04/17/2015SLR42613009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021419s009,021475s009lbl.pdf 4/21/2015




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