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FDA Drug Application 021829 by UCB INC

Application Number021829
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
AP05/9/2007N16559000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021829lbl.pdf 5/10/2007
AP05/9/2007N16560000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021829ppi.pdf 5/10/2007
AP05/9/2007N16566000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021829s000ltr.pdf 5/16/2007
AP05/9/2007N16868000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021829s000TOC.cfm 7/2/2007
AP04/2/2012SE132346001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021829s001lbl.pdf 4/2/2012
AP04/2/2012SE132350001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021829s001,s002ltr.pdf 4/4/2012
AP04/2/2012SE146732001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021829Orig1s001s002.pdf 8/5/2016
AP04/2/2012SE132347002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021829s002lbl.pdf 4/2/2012
AP04/2/2012SE132351002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021829s001,s002ltr.pdf 4/4/2012
AP04/2/2012SE146733002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021829Orig1s001s002.pdf 8/5/2016
AP02/26/2015SLR41948007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021829Orig1s007ltr.pdf 2/27/2015
AP02/26/2015SLR41974007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021829s007lbl.pdf 3/2/2015
AP09/10/2015SCM       
AP06/3/2016SCM       




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