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FDA Drug Application 019785 by LANTHEUS MEDCL

Application Number019785
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
AP012/21/1990N       
AP01/30/1992SCM       
AP09/9/1992SE1       
AP02/28/1996SCS       
AP012/14/1995SE1       
AP012/14/1995SE5       
AP05/23/1997SE5       
AP011/8/1996SCS       
AP09/26/1996SCM       
AP04/24/1997SCM       
AP08/8/1997SCM       
AP06/10/1998SCS       
AP01/22/2002SLR       
AP01/14/2000SLR       
AP02/11/2000SCM       
AP06/8/2000SCS       
AP04/30/2008SE520023018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019785s018lbl.pdf 6/18/2008
AP04/30/2008SE520024018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019785s018ltr.pdf 6/18/2008
AP04/30/2008SE520254018   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/019785se5-018_SumR.pdf 7/17/2008
AP010/20/2016SCM       




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