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FDA Drug Application 021064 by LANTHEUS MEDCL

Application Number021064
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
AP07/31/2001N1653000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-064_Definity.cfm 7/31/2001
AP07/31/2001N4670000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-064_Definity_Approv.pdf 7/31/2001
AP07/31/2001N4671000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-064_Definity_prntlbl.pdf 7/31/2001
AP07/31/2001N6910000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110260.htm 11/20/2003
AP02/21/2002SLR1652001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21064s1ltr.pdf 2/21/2002
AP07/8/2002SLR1651002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21064slr002ltr.pdf 7/8/2002
AP01/30/2003SCI8884004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21064scm004ltr.pdf 6/2/2004
AP05/6/2005SLR18182006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021064s006lbl.pdf 10/4/2007
AP010/10/2007SLR18209007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021064s007lbl.pdf 10/10/2007
AP010/10/2007SLR18239007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021064s007ltr.pdf 10/15/2007
AP05/12/2008SLR19831009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021064s009ltr.pdf 5/14/2008
AP05/12/2008SLR19941009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021064s009lbl.pdf 6/5/2008
AP010/24/2011SE830409011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021064s011lbl.pdf 10/25/2011
AP010/24/2011SE830426011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021064s011ltr.pdf 10/26/2011
AP010/24/2011SE833434011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021064Orig1s011TOC.cfm 8/14/2012
AP010/24/2011SE833435011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021064Orig1s011SumR.pdf 8/14/2012
AP02/5/2013SCM       
AP08/18/2015SLR43677017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021064s017lbl.pdf 8/19/2015
AP08/18/2015SLR43678017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021064Orig1s017ltr.pdf 8/20/2015
AP011/23/2015SCM       
AP08/29/2016SCM       




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