Back to FDA Applications sponsored by UCB INC

FDA Drug Application 022254 by UCB INC

Application Number022254
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
AP010/28/2008N21105000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022254lbl.pdf 10/29/2008
AP010/28/2008N21113000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022253s000, 022254s000ltr.pdf 10/31/2008
AP010/28/2008N21352000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022253s000_022254s000_SumR.pdf 12/17/2008
AP010/28/2008N21353000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022253s000_022254s000TOC.cfm 12/17/2008
AP010/28/2008N34545000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089816.pdf 12/5/2012
AP011/18/2009SLR24035001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022253s004,022254s001lbl.pdf 11/20/2009
AP011/18/2009SLR24036001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022253s004,022254s001MedGuide.pdf 11/20/2009
AP011/18/2009SLR24567001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022253s004,022254s001ltr.pdf 1/20/2010
AP04/20/2010SLR25452003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022255s000,022254s003,022253s006ltr.pdf 5/4/2010
AP04/20/2010SLR33571003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022255lbl.pdf 8/28/2012
AP02/8/2013SLR35130005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s010,022254Orig1s005,022255Orig1s002ltr.pdf 2/12/2013
AP02/8/2013SLR35149005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s010,022254s005,022255s002lbl.pdf 2/12/2013
AP09/25/2013SLR37236008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s014,s016,022254Orig1s008,s009,022255Orig1s003,s005ltr.pdf 9/26/2013
AP09/25/2013SLR37247008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s014s016,022254s008s009,022255s003s005lbl.pdf 9/27/2013
AP09/25/2013SLR37248009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s014s016,022254s008s009,022255s003s005lbl.pdf 9/27/2013
AP09/25/2013SLR37237009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s014,s016,022254Orig1s008,s009,022255Orig1s003,s005ltr.pdf 9/26/2013
AP08/10/2011SLR29762013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022253s020,022254s013,022255s007ltr.pdf 8/12/2011
AP02/5/2013SLR35090014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s021,022254s014,022255s008lbl.pdf 2/6/2013
AP02/5/2013SLR35094014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s021,022254Orig1s014,022255Orig1s008ltr.pdf 2/7/2013
AP01/16/2014SLR38318015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022253Orig1s023,022254Orig1s015,022255Orig1s009ltr.pdf 1/17/2014
AP01/16/2014SLR38330015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022253s023,022254s015,022255s009lbl.pdf 1/17/2014
AP07/18/2016SCM       
AP010/2/2013SCM       
AP04/17/2013SLR35757018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s024,022254s018,022255s010lbl.pdf 4/19/2013
AP04/17/2013SLR35767018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s024,022254Orig1s018,022255Orig1s010ltr.pdf 4/23/2013
AP08/29/2014SE840364019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022253Orig1s026,s027,022254s019,s020,022255s012,s013ltr.pdf 9/3/2014
AP08/29/2014SE840395019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022255s026s027,022254s019s020,022255s012s013lbl.pdf 9/3/2014
AP08/29/2014SE840396020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022255s026s027,022254s019s020,022255s012s013lbl.pdf 9/3/2014
AP08/29/2014SE840365020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022253Orig1s026,s027,022254s019,s020,022255s012,s013ltr.pdf 9/3/2014
AP08/12/2014SLR40218021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022253s028,022254s021,022255s014lbl.pdf 8/13/2014
AP08/12/2014SLR40227021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022253Orig1s028,022254Orig1s021,022255Orig1s014ltr.pdf 8/14/2014
AP07/9/2015SLR43333022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022253Orig1s030,022254Orig1s022,022255Orig1s016ltr.pdf 7/13/2015
AP07/9/2015SLR43341022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022253s030,022254s022,022255s016lbl.pdf 7/13/2015
AP06/10/2016SCM       




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.