Back to FDA Applications sponsored by UCB INC

FDA Drug Application 021505 by UCB INC

Application Number021505
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
AP07/15/2003N6162000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21505ltr.pdf 7/28/2003
AP07/15/2003N7134000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm 3/28/2007
AP07/15/2003N10526000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/0221505_s000_Keppra.cfm 11/1/2004
AP07/15/2003N23481000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM152832.pdf 9/30/2009
AP010/26/2004SLR10493002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21035s032,21505s002ltr.pdf 10/29/2004
AP010/26/2004SLR10494003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21035s033,21505s003ltr.pdf 10/29/2004
AP01/24/2006SLR13553006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021505s006_021035s038ltr.pdf 1/30/2006
AP06/21/2005SE511868007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021035s040,021505s007ltr.pdf 6/23/2005
AP06/21/2005SE511878007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021035s040,021505s007lbl.pdf 6/23/2005
AP08/15/2006SE114714009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021035s050s054,021505s009lbl.pdf 8/18/2006
AP08/15/2006SE114729009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021035s050, 054, 21505s009LTR.pdf 8/18/2006
AP03/19/2007SE116077013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021035s057, 021505s013ltr.pdf 3/23/2007
AP03/19/2007SE116089013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021035s057,021505s013lbl.pdf 3/23/2007
AP09/12/2007SLR17981015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021872s002,021872s003,021035s062,021505s015ltr.pdf 9/25/2007
AP012/16/2011SLR31130019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf 12/20/2011
AP012/16/2011SLR31138019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026mg.pdf 12/20/2011
AP012/16/2011SLR31175019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s052,s073,s074,s083,s085,021505s019,s020,s025,s026ltr.pdf 12/21/2011
AP012/16/2011SLR31176020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s052,s073,s074,s083,s085,021505s019,s020,s025,s026ltr.pdf 12/21/2011
AP012/16/2011SLR31139020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026mg.pdf 12/20/2011
AP012/16/2011SLR31129020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf 12/20/2011
AP04/23/2009SLR22406021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021035s078,s080.021505s021,s024ltr.pdf 5/4/2009
AP04/23/2009SLR22551021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021035s078s080,021505s021s024lbl.pdf 5/13/2009
AP04/23/2009SLR22552024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021035s078s080,021505s021s024lbl.pdf 5/13/2009
AP04/23/2009SLR22407024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021035s078,s080.021505s021,s024ltr.pdf 5/4/2009
AP012/16/2011SLR31140025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026mg.pdf 12/20/2011
AP012/16/2011SLR31131025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf 12/20/2011
AP012/16/2011SLR31177025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s052,s073,s074,s083,s085,021505s019,s020,s025,s026ltr.pdf 12/21/2011
AP012/16/2011SLR31178026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s052,s073,s074,s083,s085,021505s019,s020,s025,s026ltr.pdf 12/21/2011
AP012/16/2011SLR31132026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf 12/20/2011
AP012/16/2011SLR31141026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026mg.pdf 12/20/2011
AP08/10/2011SLR29753029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s090,021505s029,022285s014ltr.pdf 8/12/2011
AP07/25/2013SLR36622030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021035Orig1s089,021505Orig1s030,021872Orig1s012,s013,022285Orig1s015ltr.pdf 7/26/2013
AP07/25/2013SLR36645030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021035s089,021505s030lbl.pdf 7/30/2013
AP03/7/2014SLR38741031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021505s031lbl.pdf 3/10/2014
AP03/7/2014SLR38747031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s091,021505Orig1s031,021872Orig1s015,022285Orig1s016,s019ltr.pdf 3/11/2014
AP09/13/2013SCM       
AP03/10/2015SLR42108033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021035Orig1s093,021505Orig1s033,021872Orig1s017,022285Orig1s017ltr.pdf 3/12/2015
AP03/10/2015SLR42122033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021035s093,021505s033lbl.pdf 3/12/2015
AP08/7/2014SLR40186034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021035s094,021505s034lbl.pdf 8/8/2014
AP08/7/2014SLR40191034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s094,021505Orig1s034,021872Orig1s018,022285Orig1s020ltr.pdf 8/11/2014
AP010/26/2016SLR47503036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022285Orig1s023,021035Orig1s096,021505Orig1s036,021872Orig1s022ltr.pdf 10/28/2016




Back to FDA Applications sponsored by UCB INC

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.