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FDA Drug Application 018021 by LEDERLE

Application Number018021
Application Type New Drug Application
Sponsor ApplicantLEDERLE
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
AP09/22/1980N16486000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 5/9/2007
AP02/9/1981SCP       
AP02/9/1981SCE       
AP04/13/1981SCM       
AP02/17/1981SCM       
AP06/22/1981SLR       
AP06/22/1981SCP       
AP012/22/1981SCP       
AP01/12/1982SLR       
AP05/18/1982SCM       
AP05/4/1983SCS       
AP010/4/1982SLR       
AP01/25/1983SLR       
AP08/23/1983SCS       
AP04/6/2000SLR       
AP012/13/1984SCF       
AP02/26/1985SCM       
AP06/6/1985SLR       
AP02/18/1988SOA       
AP02/18/1988SLR       
AP010/20/1986SCS       
AP02/18/1988SLR       
AP06/4/1987SCS       
AP07/30/1987SLR       
AP02/18/1988SLR       
AP04/6/2000SLR       
AP01/3/1991SCS       
AP03/29/1994SCM       
AP05/3/1995SCS       
AP04/6/2000SLR       
AP08/29/1996SCS       
AP02/6/1997SCM       
AP05/14/1997SCS       
AP04/6/2000SLR       
AP03/5/1999SCM       
AP03/4/1999SCS       
AP09/25/2001SLR       




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