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FDA Drug Application 019638 by ORGANON USA INC

Application Number019638
Application Type New Drug Application
Sponsor ApplicantORGANON USA INC
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
AP06/26/1990N       
AP012/24/1991SLR       
AP03/18/1993SCS       
AP02/28/1994SCM       
AP05/5/1995SCS       
AP011/22/2010SLR27079005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019638s005ltr.pdf 11/30/2010




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