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FDA Drug Application 022157 by UCB INC

Application Number022157
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
AP01/28/2008N25158000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022157_xyzal_toc.cfm 4/1/2010
AP01/28/2008N25159000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022157s000SumR.pdf 4/1/2010
AP01/28/2008N18973000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022157lbl.pdf 1/30/2008
AP01/28/2008N18980000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022157s000ltr.pdf 1/30/2008
AP06/25/2008SLR20101001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022157s001ltr.pdf 6/30/2008
AP06/25/2008SLR20115001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022157s001lbl.pdf 6/30/2008
AP08/21/2009SE523546003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022064s017,022157s003lbl.pdf 10/6/2009
AP08/21/2009SE523778003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022064s017,022157s003ltr.pdf 11/10/2009
AP03/7/2011SLR28125007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022064s020,022157s007lbl.pdf 3/7/2011
AP03/7/2011SLR28190007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022064s020,022157s007ltr.pdf 3/10/2011
AP09/6/2012SLR33679008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022064Orig1s024,022157Orig1s008ltr.pdf 9/7/2012
AP09/6/2012SLR33709008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022064s024,022157s008lbl.pdf 9/11/2012
AP01/5/2015SCM       
AP02/14/2014SCM       
AP011/7/2013SLR37763012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022064s028_022157s012lbl.pdf 11/8/2013
AP011/7/2013SLR37772012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022064Orig1s028,022157Orig1s012ltr.pdf 11/8/2013
AP06/23/2016SLR46414013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022064Orig1s030,022157Orig1s013ltr.pdf 6/24/2016
AP06/23/2016SLR46422013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022064s030,022157s013lbl.pdf 6/27/2016




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