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FDA Drug Application 021726 by UCB INC

Application Number021726
Application Type New Drug Application
Sponsor ApplicantUCB INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/19/2005N11032000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021726ltr.pdf 1/26/2005
AP01/19/2005N11050000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021726lbl.pdf 1/26/2005
AP01/19/2005N14535000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021726s000_NiravamTOC.cfm 7/25/2006
AP02/6/2006SCP13591006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021726s006lbl.pdf 2/7/2006
AP02/6/2006SCP13592006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021726s006ltr.pdf 2/7/2006
AP06/16/2011SLR29199008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021726s008lbl.pdf 6/16/2011
AP06/16/2011SLR29255008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021726s008ltr.pdf 6/24/2011
AP012/14/2012SCM       




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