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FDA Drug Application 014694 by ORGANON USA INC

Application Number014694
Application Type New Drug Application
Sponsor ApplicantORGANON USA INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/4/1964N       
AP04/27/1981SCS       
AP04/27/1981SCM       
AP01/23/1984SCM       
AP02/21/1985SLR       
AP06/2/1987SCS       
AP03/28/1988SLR       
AP03/24/1992SCM       
AP02/28/1994SCM       
AP08/2/1995SCM       
AP011/8/1995SLR       
AP07/16/2014SLR39883030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014694s030lbl.pdf 7/17/2014
AP07/16/2014SLR39887030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/014694Orig1s030ltr.pdf 7/17/2014




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