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FDA Drug Application 019111 by UCB INC

Application Number019111
Application Type New Drug Application
Sponsor ApplicantUCB INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/31/1987N19452000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107208.htm 3/13/2008
AP012/20/1993SCM       
AP011/26/1993SLR       
AP011/26/1993SLR       
AP012/27/1996SCS       
AP07/30/1999SCM       
AP02/29/2000SCS       
AP03/3/2000SCM       
AP011/13/2000SCS       
AP06/7/2001SCS       
AP011/12/2003SLR6932011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19111slr011ltr.pdf 11/25/2003
AP011/12/2003SLR20397011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019111_s011_TUSSIONEX KINETIC.pdf 8/1/2008
AP03/11/2008SLR19443015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019111s015lbl.pdf 3/13/2008
AP03/11/2008SLR19444015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019111s015ltr.pdf 3/13/2008
AP06/2/2011SCM29077016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019111s016ltr.pdf 6/9/2011
AP03/21/2014SCM       
AP04/1/2015SLR42384018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019111s018lbl.pdf 4/2/2015
AP04/1/2015SLR42417018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019111Orig1s018ltr.pdf 4/3/2015




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