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FDA Drug Application 022014 by ELAN PHARMA INTL LTD

Application Number022014
Application Type New Drug Application
Sponsor ApplicantELAN PHARMA INTL LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/27/2007N17419000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022014lbl.pdf 7/30/2007
AP07/27/2007N17428000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022014s000ltr.pdf 7/31/2007
AP07/27/2007N22304000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022014_evamist_toc.cfm 4/22/2009
AP07/27/2007N22305000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022014s000_SumR.pdf 4/22/2009
AP07/27/2007N26130000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm220264.htm 8/9/2010
AP04/11/2008SLR19651001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022014s001ltr.pdf 4/16/2008
AP04/11/2008SLR19670001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022014s001lbl.pdf 4/16/2008
AP010/30/2008SCA21132005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022014s005ltr.pdf 11/3/2008
AP03/11/2014SLR38775006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022014Orig1s006ltr.pdf 3/13/2014
AP03/11/2014SLR38788006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022014s006lbl.pdf 3/13/2014
AP010/26/2011SLR30434009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022014s009ltr.pdf 10/31/2011
AP010/26/2011SLR30456009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022014s009lbl.pdf 11/1/2011
AP01/15/2013SCM       




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