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FDA Drug Application 017015 by ORGANON USA INC

Application Number017015
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/24/1972N       
AP011/11/1974SFP       
AP010/8/1974SCS       
AP09/22/1975SLR       
AP01/26/1977SCE       
AP03/17/1982SCM       
AP03/17/1982SLR       
AP04/2/1986SPD       
AP06/27/1986SCS       
AP010/8/1987SCS       
AP03/29/1993SCE       
AP07/25/1991SLR       
AP010/5/1990SCM       
AP05/17/1995SCS       
AP02/28/1994SCM       
AP03/22/2000SCS       
AP011/24/2010SLR27088023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017015s023ltr.pdf 11/30/2010
AP011/24/2010SLR27120023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017015s023lbl.pdf 12/1/2010




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