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FDA Drug Application 125160 by UCB INC

Application Number125160
Application Type Biologic License Application
Sponsor ApplicantUCB INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/22/2008N23914000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088571.pdf 11/16/2009
AP04/22/2008N19748000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125160s000ltr.pdf 4/30/2008
AP04/22/2008N19785000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125160s000lbl.pdf 5/8/2008
AP04/22/2008N20155000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125160s000TOC2.cfm 7/7/2008
AP04/22/2008N20203000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125160s000_SumR.pdf 7/14/2008
AP04/22/2008N20733000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109340.htm 9/4/2008
AP04/17/2012SE8324810174   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s0174lbl.pdf 4/20/2012
AP04/17/2012SE8324820174   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s0174mg.pdf 4/20/2012
AP04/17/2012SE8324950174   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125160s0174ltr.pdf 4/23/2012
AP012/31/2008S21694038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125160s038ltr.pdf 1/30/2009
AP05/13/2009S36991080   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2009/125160Orig1s080.pdf 9/9/2013
AP011/18/2009S24178092   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125160s092ltr.pdf 12/2/2009
AP011/18/2009S24284092   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125160s092lbl.pdf 12/12/2009
AP07/29/2010S26090111   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125160s111ltr.pdf 8/2/2010
AP07/29/2010S26189111   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125160s111MedGuide.pdf 8/10/2010
AP07/29/2010S26190111   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125160s111lbl.pdf 8/10/2010
AP010/6/2010S26892126   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125160s126ltr.pdf 11/4/2010
AP08/2/2012SLR33357142   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s0142mg.pdf 8/3/2012
AP08/2/2012SLR33358142   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s0142lbl.pdf 8/3/2012
AP08/2/2012SLR33371142   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125160Orig1s142ltr.pdf 8/6/2012
AP09/7/2011S29981157   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125160s157ltr.pdf 9/13/2011
AP08/29/2012SLR33602180   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125160Orig1s180ltr.pdf 8/31/2012
AP08/29/2012SLR33612180   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s180mg.pdf 8/31/2012
AP08/29/2012SLR33613180   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s180lbl.pdf 8/31/2012
AP010/5/2012SLR34016186   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s186s192lbl.pdf 10/9/2012
AP010/5/2012SLR34018186   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s186s192mg.pdf 10/9/2012
AP010/5/2012SLR34026186   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125160Orig1s186,s192ltr.pdf 10/10/2012
AP011/15/2012SLR34415189   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125160Orig1s189ltr.pdf 11/16/2012
AP011/15/2012SLR34418189   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s189lbl.pdf 11/16/2012
AP011/15/2012SLR34419189   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s189mg.pdf 11/16/2012
AP010/5/2012SLR34027192   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125160Orig1s186,s192ltr.pdf 10/10/2012
AP010/5/2012SLR34019192   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s186s192mg.pdf 10/9/2012
AP010/5/2012SLR34017192   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125160s186s192lbl.pdf 10/9/2012
AP09/27/2013SE837278213   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125160Orig1s213ltr.pdf 10/1/2013
AP09/27/2013SE837310213   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125160s213lbl.pdf 10/1/2013
AP010/17/2013SE837461215   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125160Orig1s215ltr_replace.pdf 10/18/2013
AP010/17/2013SE837504215   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125160s215lbl.pdf 10/22/2013
AP04/28/2016SLR45803241   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125160s241lbl.pdf 4/29/2016
AP04/28/2016SLR45852241   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125160Orig1s241ltr.pdf 5/4/2016
AP010/19/2015SLR44236264   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125160Orig1s264ltr.pdf 10/21/2015
AP010/19/2015SLR44257264   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125160s264lbl.pdf 10/22/2015
AP02/3/2016SLR45120268   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125160Orig1s268ltr.pdf 2/4/2016
AP02/3/2016SLR45154268   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125160s268lbl.pdf 2/11/2016




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