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FDA Drug Application 017692 by ORGANON USA INC

Application Number017692
Application Type New Drug Application
Sponsor ApplicantORGANON USA INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/20/1976N       
AP06/3/1981SCS       
AP04/5/1982SCM       
AP011/9/1984SCM       
AP012/24/1986SCS       
AP02/17/1987SCS       
AP04/19/1988SCS       
AP011/3/1988SCM       
AP01/2/1991SCM       
AP06/30/1992SCS       
AP02/18/1994SCM       
AP02/21/1997SCM       
AP011/23/1999SLR       
AP04/2/1999SCM       
AP02/7/2007SLR15819018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017692s018ltr.pdf 2/12/2007
AP02/7/2007SLR15854018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017692s018lbl.pdf 2/21/2007
AP012/3/2007SLR18866020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017692s020ltr.pdf 1/9/2008
AP04/15/2011SLR28563021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017692s021lbl.pdf 4/18/2011
AP04/15/2011SLR28572021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017692s021ltr.pdf 4/19/2011
AP02/26/2013SCM       
AP02/28/2014SCM       
AP01/12/2015SCM       
AP010/2/2015SCM       




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