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FDA Drug Application 017386 by UCB INC

Application Number017386
Application Type New Drug Application
Sponsor ApplicantUCB 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
AP011/27/1973N       
AP04/25/1978SCP       
AP04/25/1978SLR       
AP05/11/1977SCF       
AP01/3/1980SDS       
AP09/12/1989SCS       
AP012/2/1982SCS       
AP012/2/1982SCF       
AP07/15/1983SCS       
AP07/15/1983SCS       
AP02/18/1983SLR       
AP09/30/1987SPD       
AP02/7/1984SCP       
AP02/7/1984SCS       
AP08/12/1985SLR       
AP02/1/1988SCP       
AP08/26/1987SCS       
AP012/9/1988SCS       
AP010/10/1989SLR       
AP01/13/1993SLR       
AP01/13/1994SLR       
AP05/4/1994SCS       
AP05/23/1995SLR       
AP01/7/1997SCP       
AP07/14/1997SCS       
AP08/13/1999SLR       
AP010/18/2001SCS       
AP08/10/2001SLR5917032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17386s32lbl.pdf 6/16/2003
AP04/15/2002SCS       
AP010/29/2002SLR2034034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17386slr034,19532slr015ltr.pdf 10/29/2002
AP08/19/2003SLR6534036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17386slr036,19532slr016ltr.pdf 8/25/2003
AP011/22/2013SCM       
AP03/30/2015SCM       




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