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FDA Drug Application 020071 by ORGANON USA INC

Application Number020071
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); New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/10/1992N       
AP03/9/1993SLR       
AP04/28/1995SLR       
AP02/3/1995SLR       
AP02/18/1994SCM       
AP04/25/1995SCM       
AP07/26/1996SLR       
AP03/5/1998SLR       
AP011/20/1997SCS       
AP011/20/1997SCS       
AP02/24/1998SCF       
AP011/19/1998SCM       
AP011/27/2000SCM       
AP08/11/2004SLR9996014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20071s014ltr.pdf 8/11/2004
AP03/8/2002SCS       
AP06/7/2007SLR16755017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020071s017lbl.pdf 6/12/2007
AP06/7/2007SLR16772017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020071s017ltr.pdf 6/14/2007
AP02/11/2016SCM       
AP01/12/2015SCM       
AP011/30/2015SCM       




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