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FDA Drug Application 022253 by UCB INC

Application Number022253
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
AP010/28/2008N21106000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022253lbl.pdf 10/29/2008
AP010/28/2008N21112000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022253s000, 022254s000ltr.pdf 10/31/2008
AP010/28/2008N21350000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022253s000_022254s000TOC.cfm 12/17/2008
AP010/28/2008N21351000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022253s000_022254s000_SumR.pdf 12/17/2008
AP010/28/2008N34544000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089816.pdf 12/5/2012
AP011/18/2009SLR24034004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022253s004,022254s001lbl.pdf 11/20/2009
AP011/18/2009SLR24037004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022253s004,022254s001MedGuide.pdf 11/20/2009
AP011/18/2009SLR24566004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022253s004,022254s001ltr.pdf 1/20/2010
AP04/20/2010SLR25453006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022255s000,022254s003,022253s006ltr.pdf 5/4/2010
AP04/20/2010SLR33570006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022255lbl.pdf 8/28/2012
AP02/8/2013SLR35129010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s010,022254Orig1s005,022255Orig1s002ltr.pdf 2/12/2013
AP02/8/2013SLR35150010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s010,022254s005,022255s002lbl.pdf 2/12/2013
AP09/25/2013SLR37234014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s014,s016,022254Orig1s008,s009,022255Orig1s003,s005ltr.pdf 9/26/2013
AP09/25/2013SLR37249014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s014s016,022254s008s009,022255s003s005lbl.pdf 9/27/2013
AP09/25/2013SLR37250016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s014s016,022254s008s009,022255s003s005lbl.pdf 9/27/2013
AP09/25/2013SLR37235016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s014,s016,022254Orig1s008,s009,022255Orig1s003,s005ltr.pdf 9/26/2013
AP08/10/2011SLR29761020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022253s020,022254s013,022255s007ltr.pdf 8/12/2011
AP02/5/2013SLR35091021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s021,022254s014,022255s008lbl.pdf 2/6/2013
AP02/5/2013SLR35093021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s021,022254Orig1s014,022255Orig1s008ltr.pdf 2/7/2013
AP012/3/2012SCM       
AP01/16/2014SLR38319023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022253Orig1s023,022254Orig1s015,022255Orig1s009ltr.pdf 1/17/2014
AP01/16/2014SLR38331023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022253s023,022254s015,022255s009lbl.pdf 1/17/2014
AP04/17/2013SLR35758024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s024,022254s018,022255s010lbl.pdf 4/19/2013
AP04/17/2013SLR35766024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s024,022254Orig1s018,022255Orig1s010ltr.pdf 4/23/2013
AP010/11/2013SCM       
AP08/29/2014SE840362026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022253Orig1s026,s027,022254s019,s020,022255s012,s013ltr.pdf 9/3/2014
AP08/29/2014SE840397026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022255s026s027,022254s019s020,022255s012s013lbl.pdf 9/3/2014
AP08/29/2014SE840398027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022255s026s027,022254s019s020,022255s012s013lbl.pdf 9/3/2014
AP08/29/2014SE840363027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022253Orig1s026,s027,022254s019,s020,022255s012,s013ltr.pdf 9/3/2014
AP08/12/2014SLR40226028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022253Orig1s028,022254Orig1s021,022255Orig1s014ltr.pdf 8/14/2014
AP08/12/2014SLR40262028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022253s028,022254s021,022255s014lbl.pdf 8/19/2014
AP06/4/2014SCM       
AP07/9/2015SLR43332030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022253Orig1s030,022254Orig1s022,022255Orig1s016ltr.pdf 7/13/2015
AP07/9/2015SLR43342030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022253s030,022254s022,022255s016lbl.pdf 7/13/2015
AP04/15/2015SCM       
AP05/5/2016SCM       
AP05/27/2016SCM       
AP010/3/2016SCM       




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