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FDA Drug Application 022064 by UCB INC

Application Number022064
Application Type New Drug Application
Sponsor ApplicantUCB INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/25/2007N19632000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022064s000ltr.pdf 4/9/2008
AP05/25/2007N19633000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022064lbl.pdf 4/9/2008
AP05/25/2007N21025000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022064_xyzal_toc.cfm 10/15/2008
AP05/25/2007N21026000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022064s000_SumR.pdf 10/15/2008
AP01/31/2008SLR19053005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022064s005ltr.pdf 2/5/2008
AP01/31/2008SLR19134005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022064s005lbl.pdf 2/14/2008
AP03/31/2008SLR19556009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022064s009lbl.pdf 4/1/2008
AP03/31/2008SLR19566009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022064s009ltr.pdf 4/2/2008
AP08/21/2009SE523547017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022064s017,022157s003lbl.pdf 10/6/2009
AP08/21/2009SE523777017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022064s017,022157s003ltr.pdf 11/10/2009
AP03/7/2011SLR28126020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022064s020,022157s007lbl.pdf 3/7/2011
AP03/7/2011SLR28189020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022064s020,022157s007ltr.pdf 3/10/2011
AP09/6/2012SLR33678024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022064Orig1s024,022157Orig1s008ltr.pdf 9/7/2012
AP09/6/2012SLR33710024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022064s024,022157s008lbl.pdf 9/11/2012
AP011/20/2012SCM       
AP02/14/2014SCM       
AP011/7/2013SLR37762028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022064s028_022157s012lbl.pdf 11/8/2013
AP011/7/2013SLR37771028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022064Orig1s028,022157Orig1s012ltr.pdf 11/8/2013
AP06/23/2016SLR46413030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022064Orig1s030,022157Orig1s013ltr.pdf 6/24/2016
AP06/23/2016SLR46421030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022064s030,022157s013lbl.pdf 6/27/2016




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