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FDA Drug Application 020729 by UCB INC

Application Number020729
Application Type New Drug Application
Sponsor ApplicantUCB INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/27/1997N       
AP011/18/1997SCM       
AP01/21/1998SLR       
AP04/22/1999SCP       
AP010/29/1999SCM       
AP04/5/2000SLR       
AP05/10/2000SCM       
AP01/12/2001SCM       
AP012/22/2000SCP       
AP09/24/2001SCS       
AP02/14/2002SCF1990010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20729s10ltr.pdf 2/14/2002
AP02/14/2002SCF18092010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020729_S010_UNIRETIC.pdf 9/26/2007
AP010/29/2003SLR6981012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20312slr012,20312slr024ltr.pdf 11/25/2003
AP01/13/2010SLR24516021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020729s021ltr.pdf 1/15/2010
AP01/13/2010SLR24550021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020729s021lbl.pdf 1/20/2010
AP05/19/2011SLR28892023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020729s023lbl.pdf 5/23/2011
AP08/23/2011SLR29890024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020729s024ltr.pdf 8/26/2011
AP08/23/2011SLR29947024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020729s024lbl.pdf 9/2/2011
AP01/19/2012SLR31441025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020312s034,020729s025ltr.pdf 1/23/2012
AP01/19/2012SLR31443025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020729s025lbl.pdf 1/23/2012
AP09/13/2012SLR33756026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020729s026lbl.pdf 9/14/2012
AP09/13/2012SLR33766026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020729Orig1s026ltr.pdf 9/17/2012




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