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FDA Drug Application 021035 by UCB INC

Application Number021035
Application Type New Drug Application
Sponsor ApplicantUCB INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/30/1999N1986000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21035ltr.pdf 11/30/1999
AP011/30/1999N1987000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21035lbl.pdf 11/30/1999
AP011/30/1999N1988000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21035_Keppra.cfm 11/30/1999
AP011/30/1999N7133000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm 3/28/2007
AP011/30/1999N23480000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM152832.pdf 9/30/2009
AP04/10/2000SLR       
AP05/15/2000SCM       
AP07/27/2000SCM       
AP08/9/2000SCM       
AP010/4/2000SCM       
AP012/4/2000SCS       
AP012/4/2000SCS       
AP07/5/2001SCS       
AP04/26/2001SCM       
AP011/27/2001SCM       
AP05/22/2002SLR1984013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21035slr013ltr.pdf 5/22/2002
AP011/27/2001SCM       
AP010/24/2001SCS       
AP01/4/2002SCM       
AP01/4/2002SCM       
AP05/7/2002SCM       
AP05/22/2002SLR1985019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21035slr013ltr.pdf 5/22/2002
AP04/1/2002SCS       
AP04/17/2002SCS       
AP010/17/2002SCS       
AP09/3/2003SLR6612030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21035slr030lr.pdf 9/9/2003
AP010/26/2004SLR10492032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21035s032,21505s002ltr.pdf 10/29/2004
AP010/26/2004SLR10495033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21035s033,21505s003ltr.pdf 10/29/2004
AP01/24/2006SLR13552038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021505s006_021035s038ltr.pdf 1/30/2006
AP06/21/2005SE511869040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021035s040,021505s007ltr.pdf 6/23/2005
AP06/21/2005SE511879040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021035s040,021505s007lbl.pdf 6/23/2005
AP01/6/2006SCF13433048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021035s048ltr.pdf 1/20/2006
AP08/15/2006SE114715050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021035s050s054,021505s009lbl.pdf 8/18/2006
AP08/15/2006SE114730050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021035s050, 054, 21505s009LTR.pdf 8/18/2006
AP012/16/2011SLR31133052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf 12/20/2011
AP012/16/2011SLR31170052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s052,s073,s074,s083,s085,021505s019,s020,s025,s026ltr.pdf 12/21/2011
AP012/16/2011SLR31142052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026mg.pdf 12/20/2011
AP08/15/2006SLR14731054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021035s050, 054, 21505s009LTR.pdf 8/18/2006
AP08/15/2006SLR14716054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021035s050s054,021505s009lbl.pdf 8/18/2006
AP03/19/2007SE116078057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021035s057, 021505s013ltr.pdf 3/23/2007
AP03/19/2007SE116090057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021035s057,021505s013lbl.pdf 3/23/2007
AP09/12/2007SLR17980062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021872s002,021872s003,021035s062,021505s015ltr.pdf 9/25/2007
AP012/16/2011SE831171073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s052,s073,s074,s083,s085,021505s019,s020,s025,s026ltr.pdf 12/21/2011
AP012/16/2011SE831134073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf 12/20/2011
AP012/16/2011SE831143073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026mg.pdf 12/20/2011
AP012/16/2011SLR31144074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026mg.pdf 12/20/2011
AP012/16/2011SLR31135074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf 12/20/2011
AP012/16/2011SLR31172074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s052,s073,s074,s083,s085,021505s019,s020,s025,s026ltr.pdf 12/21/2011
AP04/23/2009SLR22549078   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021035s078s080,021505s021s024lbl.pdf 5/13/2009
AP04/23/2009SLR22404078   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021035s078,s080.021505s021,s024ltr.pdf 5/4/2009
AP04/23/2009SLR22405080   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021035s078,s080.021505s021,s024ltr.pdf 5/4/2009
AP04/23/2009SLR22550080   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021035s078s080,021505s021s024lbl.pdf 5/13/2009
AP012/16/2011SLR31136083   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf 12/20/2011
AP012/16/2011SLR31173083   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s052,s073,s074,s083,s085,021505s019,s020,s025,s026ltr.pdf 12/21/2011
AP012/16/2011SLR31145083   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026mg.pdf 12/20/2011
AP012/16/2011SLR31146085   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026mg.pdf 12/20/2011
AP012/16/2011SLR31174085   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s052,s073,s074,s083,s085,021505s019,s020,s025,s026ltr.pdf 12/21/2011
AP012/16/2011SLR31137085   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf 12/20/2011
AP07/25/2013SLR36621089   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021035Orig1s089,021505Orig1s030,021872Orig1s012,s013,022285Orig1s015ltr.pdf 7/26/2013
AP07/25/2013SLR36646089   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021035s089,021505s030lbl.pdf 7/30/2013
AP08/10/2011SLR29752090   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s090,021505s029,022285s014ltr.pdf 8/12/2011
AP03/7/2014SLR38742091   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021035s091lbl.pdf 3/10/2014
AP03/7/2014SLR38746091   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s091,021505Orig1s031,021872Orig1s015,022285Orig1s016,s019ltr.pdf 3/11/2014
AP011/13/2012SCM       
AP03/10/2015SLR42107093   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021035Orig1s093,021505Orig1s033,021872Orig1s017,022285Orig1s017ltr.pdf 3/12/2015
AP03/10/2015SLR42123093   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021035s093,021505s033lbl.pdf 3/12/2015
AP08/7/2014SLR40187094   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021035s094,021505s034lbl.pdf 8/8/2014
AP08/7/2014SLR40190094   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s094,021505Orig1s034,021872Orig1s018,022285Orig1s020ltr.pdf 8/11/2014
AP02/4/2016SCM       
AP010/26/2016SLR47504096   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022285Orig1s023,021035Orig1s096,021505Orig1s036,021872Orig1s022ltr.pdf 10/28/2016
AP09/13/2016SCM       




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