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FDA Drug Application 021711 by LANTHEUS MEDCL

Application Number021711
Application Type New Drug Application
Sponsor ApplicantLANTHEUS MEDCL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/22/2008N21443000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021711s000ltr.pdf 1/2/2009
AP012/22/2008N22137000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021711s000TOC.cfm 3/31/2009
AP012/22/2008N22156000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021711s000_SumR.pdf 4/2/2009
AP012/22/2008N31162000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm 12/21/2011
AP01/11/2010SLR24521001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021711s001ltr.pdf 1/15/2010
AP01/11/2010SLR24685001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021711s001lbl.pdf 1/29/2010
AP012/20/2010SLR27298003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021711s003lbl.pdf 12/20/2010
AP012/20/2010SLR27354003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021711s003ltr.pdf 12/22/2010
AP08/7/2013SLR36731004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021711Orig1s004ltr.pdf 8/8/2013
AP08/7/2013SLR36761004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021711s004lbl.pdf 8/9/2013




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