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FDA Drug Application 021872 by UCB INC

Application Number021872
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
AP07/31/2006N14593000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021872lbl.pdf 8/4/2006
AP07/31/2006N16104000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm 3/28/2007
AP07/31/2006N19252000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021872s000TOC.cfm 2/22/2008
AP09/12/2007SLR17908002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021872s002s003lbl.pdf 9/19/2007
AP09/12/2007SLR17978002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021872s002,021872s003,021035s062,021505s015ltr.pdf 9/25/2007
AP09/12/2007SLR17979003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021872s002,021872s003,021035s062,021505s015ltr.pdf 9/25/2007
AP09/12/2007SLR17909003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021872s002s003lbl.pdf 9/19/2007
AP05/16/2008SE119860005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021872s005ltr.pdf 5/21/2008
AP05/16/2008SE134566005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021872s005lbl.pdf 12/7/2012
AP07/25/2013SLR36623012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021035Orig1s089,021505Orig1s030,021872Orig1s012,s013,022285Orig1s015ltr.pdf 7/26/2013
AP07/25/2013SLR36648012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021872s012s013lbl.pdf 7/30/2013
AP07/25/2013SLR36624013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021035Orig1s089,021505Orig1s030,021872Orig1s012,s013,022285Orig1s015ltr.pdf 7/26/2013
AP07/25/2013SLR36647013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021872s012s013lbl.pdf 7/30/2013
AP03/7/2014SLR38740015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021872s015lbl.pdf 3/10/2014
AP03/7/2014SLR38748015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s091,021505Orig1s031,021872Orig1s015,022285Orig1s016,s019ltr.pdf 3/11/2014
AP010/30/2014SE840919016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021872Orig1s016ltr.pdf 11/3/2014
AP010/30/2014SE840942016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021872s016lbl.pdf 11/4/2014
AP03/10/2015SLR42109017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021035Orig1s093,021505Orig1s033,021872Orig1s017,022285Orig1s017ltr.pdf 3/12/2015
AP03/10/2015SLR42124017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021872s017lbl.pdf 3/12/2015
AP08/7/2014SLR40185018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021872s018lbl.pdf 8/8/2014
AP08/7/2014SLR40192018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s094,021505Orig1s034,021872Orig1s018,022285Orig1s020ltr.pdf 8/11/2014
AP08/14/2015SCM       
AP04/6/2016SLR45737021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021872Orig1s021ltr.pdf 4/25/2016
AP04/6/2016SLR45778021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021872s021lbl.pdf 4/27/2016
AP010/26/2016SLR47502022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022285Orig1s023,021035Orig1s096,021505Orig1s036,021872Orig1s022ltr.pdf 10/28/2016




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