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FDA Drug Application 022285 by UCB INC

Application Number022285
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
AP09/12/2008N20779000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022285s000ltr.pdf 9/16/2008
AP09/12/2008N20785000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022285lbl.pdf 9/16/2008
AP09/12/2008N20843000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm 9/19/2008
AP09/12/2008N21497000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022285s000_TOC.cfm 1/6/2009
AP09/12/2008N21498000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022285s000_SumR.pdf 1/6/2009
AP09/12/2008N23482000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM312880.pdf 9/30/2009
AP02/12/2009SCF21843001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022285s001lbl.pdf 2/13/2009
AP02/12/2009SCF21865001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022285s001ltr.pdf 2/18/2009
AP04/23/2009SLR22410002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022285s002,s007ltr.pdf 5/4/2009
AP04/23/2009SLR22535002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022285s002s007lbl.pdf 5/12/2009
AP04/23/2009SLR       
AP04/23/2009SLR22536007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022285s002s007lbl.pdf 5/12/2009
AP04/23/2009SLR22411007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022285s002,s007ltr.pdf 5/4/2009
AP07/25/2013SLR36626013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021035Orig1s089,021505Orig1s030,021872Orig1s012,s013,022285Orig1s015ltr.pdf 7/26/2013
AP07/25/2013SLR36649013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022285s013s015lbl.pdf 7/30/2013
AP08/10/2011SLR29754014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s090,021505s029,022285s014ltr.pdf 8/12/2011
AP07/25/2013SLR36625015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021035Orig1s089,021505Orig1s030,021872Orig1s012,s013,022285Orig1s015ltr.pdf 7/26/2013
AP07/25/2013SLR36650015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022285s013s015lbl.pdf 7/30/2013
AP03/7/2014SLR38738016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022285s016s019lbl.pdf 3/10/2014
AP03/7/2014SLR38749016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s091,021505Orig1s031,021872Orig1s015,022285Orig1s016,s019ltr.pdf 3/11/2014
AP03/10/2015SLR42110017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021035Orig1s093,021505Orig1s033,021872Orig1s017,022285Orig1s017ltr.pdf 3/12/2015
AP03/10/2015SLR42125017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022285s017lbl.pdf 3/12/2015
AP08/1/2014SE840114018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022285Orig1s018ltr.pdf 8/4/2014
AP08/1/2014SE840117018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022285s018lbl.pdf 8/4/2014
AP03/7/2014SLR38750019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s091,021505Orig1s031,021872Orig1s015,022285Orig1s016,s019ltr.pdf 3/11/2014
AP03/7/2014SLR38739019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022285s016s019lbl.pdf 3/10/2014
AP08/7/2014SLR40184020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022285s020lbl.pdf 8/8/2014
AP08/7/2014SLR40193020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s094,021505Orig1s034,021872Orig1s018,022285Orig1s020ltr.pdf 8/11/2014
AP04/6/2016SLR45609022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022285s022lbl.pdf 4/7/2016
AP04/6/2016SLR45619022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022285Orig1s022ltr.pdf 4/8/2016
AP010/26/2016SLR47505023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022285Orig1s023,021035Orig1s096,021505Orig1s036,021872Orig1s022ltr.pdf 10/28/2016




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