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FDA Drug Application 021264 by US WORLDMEDS

Application Number021264
Application Type New Drug Application
Sponsor ApplicantUS WORLDMEDS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/20/2004N8417000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21264ltr.pdf 4/29/2004
AP04/20/2004N8496000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21264_apokyn_lbl.pdf 5/4/2004
AP04/20/2004N10088000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-264_Apokyn.cfm 8/27/2004
AP012/31/2008SLR21521003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021264s003,021264s005ltr.pdf 1/6/2009
AP012/31/2008SLR21522005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021264s003,021264s005ltr.pdf 1/6/2009
AP09/2/2010SLR26372009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021264s009ltr.pdf 9/7/2010
AP09/2/2010SLR26409009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021264s009lbl.pdf 9/7/2010
AP07/25/2014SLR40008010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021264s010lbl.pdf 7/28/2014
AP07/25/2014SLR40019010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021264Orig1s010ltr.pdf 7/28/2014




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