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FDA Drug Application 022255 by UCB INC

Application Number022255
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
AP04/20/2010N25451000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022255s000,022254s003,022253s006ltr.pdf 5/4/2010
AP04/20/2010N27107000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022255_vimpat_toc.cfm 12/1/2010
AP04/20/2010N27913000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022255Orig1s000SumR.pdf 2/17/2011
AP04/20/2010N33569000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022255lbl.pdf 8/28/2012
AP04/20/2010N34546000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089816.pdf 12/5/2012
AP02/8/2013SLR35131002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s010,022254Orig1s005,022255Orig1s002ltr.pdf 2/12/2013
AP02/8/2013SLR35148002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s010,022254s005,022255s002lbl.pdf 2/12/2013
AP09/25/2013SLR37232003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s014,s016,022254Orig1s008,s009,022255Orig1s003,s005ltr.pdf 9/26/2013
AP09/25/2013SLR37245003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s014s016,022254s008s009,022255s003s005lbl.pdf 9/27/2013
AP09/25/2013SLR37233005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s014,s016,022254Orig1s008,s009,022255Orig1s003,s005ltr.pdf 9/26/2013
AP09/25/2013SLR37246005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s014s016,022254s008s009,022255s003s005lbl.pdf 9/27/2013
AP08/10/2011SLR29763007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022253s020,022254s013,022255s007ltr.pdf 8/12/2011
AP02/5/2013SLR35089008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s021,022254s014,022255s008lbl.pdf 2/6/2013
AP02/5/2013SLR35095008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s021,022254Orig1s014,022255Orig1s008ltr.pdf 2/7/2013
AP01/16/2014SLR38317009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022255s009ltr.pdf022253Orig1s023,022254Orig1s015,022255Orig1s009ltr.pdf 1/17/2014
AP01/16/2014SLR38329009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022253s023,022254s015,022255s009lbl.pdf 1/17/2014
AP04/17/2013SLR35756010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s024,022254s018,022255s010lbl.pdf 4/19/2013
AP04/17/2013SLR35768010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s024,022254Orig1s018,022255Orig1s010ltr.pdf 4/23/2013
AP01/17/2014SCM       
AP08/29/2014SE840366012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022253Orig1s026,s027,022254s019,s020,022255s012,s013ltr.pdf 9/3/2014
AP08/29/2014SE840394012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022255s026s027,022254s019s020,022255s012s013lbl.pdf 9/3/2014
AP08/29/2014SE840367013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022253Orig1s026,s027,022254s019,s020,022255s012,s013ltr.pdf 9/3/2014
AP08/29/2014SE840393013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022255s026s027,022254s019s020,022255s012s013lbl.pdf 9/3/2014
AP08/12/2014SLR40217014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022253s028,022254s021,022255s014lbl.pdf 8/13/2014
AP08/12/2014SLR40228014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022253Orig1s028,022254Orig1s021,022255Orig1s014ltr.pdf 8/14/2014
AP04/11/2014SCM       
AP07/9/2015SLR43334016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022253Orig1s030,022254Orig1s022,022255Orig1s016ltr.pdf 7/13/2015
AP07/9/2015SLR43340016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022253s030,022254s022,022255s016lbl.pdf 7/13/2015
AP02/26/2016SCM       




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