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FDA Drug Application 021259 by UCB INC

Application Number021259
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
AP04/3/2001N5621000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21259lbl.pdf 4/3/2001
AP04/3/2001N7457000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-259_Metadate.cfm 12/31/2003
AP04/3/2001N9206000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-259_Metadate_Approv.pdf 6/9/2004
AP04/3/2001N16585000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm 5/18/2007
AP04/3/2001N24013000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088635.pdf 11/19/2009
AP04/9/2002SLR3555001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21259s1ltr.pdf 4/9/2002
AP04/9/2002SLR3556001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21259s1lbl.pdf 4/9/2002
AP09/18/2002SCM       
AP011/6/2002SCM       
AP011/6/2002SCP       
AP05/27/2003SCM5840005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21259scm005ltr.pdf 6/8/2003
AP06/19/2003SCM5973006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21259scm006ltr.pdf 6/22/2003
AP09/22/2003SCM6707008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21259scm008ltr.pdf 9/29/2003
AP02/19/2006SCS13695017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021259s017ltr.pdf 3/1/2006
AP08/10/2006SLR14660018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021259s018lbl.pdf 8/11/2006
AP08/10/2006SLR14704018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021259s018LTR.pdf 8/14/2006
AP08/26/2008SLR20691019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021259s019ltr.pdf 8/28/2008
AP08/26/2008SLR20703019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021259s019lbl.pdf 8/29/2008
AP05/4/2007SLR16440020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021259s020lbl.pdf 5/7/2007
AP05/4/2007SLR16478020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021259s020ltr.pdf 5/9/2007
AP04/16/2009SLR22314021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021259s021lbl.pdf 4/23/2009
AP04/16/2009SLR22576021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021259s021ltr.pdf 5/14/2009
AP010/18/2010SLR26683022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021259s022lbl.pdf 10/18/2010
AP010/18/2010SLR26718022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021259s022ltr.pdf 10/20/2010
AP05/6/2013SLR35945023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s023lbl.pdf 5/6/2013
AP05/6/2013SLR35970023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021259Orig1s023,s024ltr.pdf 5/7/2013
AP05/6/2013SLR35971024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021259Orig1s023,s024ltr.pdf 5/7/2013
AP05/6/2013SLR35946024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s024lbl.pdf 5/6/2013
AP06/4/2013SLR36232026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021259Orig1s026ltr.pdf 6/6/2013
AP06/4/2013SLR36273026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s026lbl.pdf 6/11/2013
AP012/13/2013SLR38061027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s027lbl.pdf 12/17/2013
AP012/13/2013SLR38064027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021259Orig1s027ltr.pdf 12/17/2013
AP06/15/2015SCM       
AP04/17/2015SLR42581029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021259Orig1s029ltr.pdf 4/20/2015
AP04/17/2015SLR42611029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021259s029lbl.pdf 4/21/2015




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