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FDA Drug Application 021507 by TAKEDA PHARMS NA

Application Number021507
Application Type New Drug Application
Sponsor ApplicantTAKEDA PHARMS NA
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
AP011/14/2003N6996000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21507ltr.pdf 11/28/2003
AP011/14/2003N11858000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21507_PrevacidTOC.cfm 6/23/2005
AP011/14/2003N15842000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088694.pdf 2/20/2007
AP011/14/2003N31071000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm 12/20/2011
AP04/12/2006SLR13928004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021507s004ltr.pdf 4/13/2006
AP08/31/2006SLR14782005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021507s005,007lbl.pdf 9/1/2006
AP08/31/2006SLR14781007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021507s005,007lbl.pdf 9/1/2006
AP010/20/2008SLR21052008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021507s008ltr.pdf 10/23/2008
AP07/31/2009S23176009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021507s009lbl.pdf 8/13/2009
AP07/31/2009S23784009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021507s009ltr.pdf 11/10/2009




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