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FDA Drug Application 011613 by UCB INC

Application Number011613
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/4/1959N       
AP04/10/1975SLR       
AP010/31/1978SCF       
AP05/2/1980SCS       
AP09/25/1980SLR       
AP02/7/1984SLR       
AP04/20/1983SCP       
AP06/16/1983SCS       
AP012/31/1985SCS       
AP07/23/1985SCS       
AP09/4/1985SLR       
AP05/4/1987SCS       
AP07/10/1987SCM       
AP08/3/1987SCS       
AP07/8/1993SCS       
AP02/27/1998SLR       
AP02/17/1998SLR       
AP010/8/2003SLR6794026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11613slr026ltr.pdf 10/16/2003
AP012/5/2012SLR34568027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/011613s027lbl.pdf 12/7/2012
AP012/5/2012SLR34587027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/011613Orig1s027ltr.pdf 12/11/2012




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