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FDA Drug Application 021011 by MALLINCKRODT INC

Application Number021011
Application Type New Drug Application
Sponsor ApplicantMALLINCKRODT INC
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
AP08/31/2000N893000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21011ltr.pdf 8/31/2000
AP08/31/2000N894000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21011lbl.pdf 8/31/2000
AP08/31/2000N7878000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-011_Roxicodone.cfm 3/10/2004
AP02/20/2009SLR21901002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021011s002ltr.pdf 2/24/2009
AP02/20/2009SLR21905002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021011s002lbl.pdf 2/24/2009
AP05/15/2009SCF22597003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021011s003ltr.pdf 5/20/2009
AP05/15/2009SCF22707003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021011s003lbl.pdf 6/7/2009




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