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FDA Drug Application 021566 by TAKEDA PHARMS NA

Application Number021566
Application Type New Drug Application
Sponsor ApplicantTAKEDA PHARMS NA
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
AP05/27/2004N8855000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21566_prevacid_lb.pdf 6/1/2004
AP05/27/2004N8867000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21566ltr.pdf 6/1/2004
AP05/27/2004N13769000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021566s000_PrevacidTOC.cfm 3/21/2006
AP05/27/2004N31072000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm 12/20/2011
AP04/5/2005SLR11375001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021566s001ltr.pdf 4/12/2005
AP04/5/2005SLR11383001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021566s001lbl.pdf 4/12/2005
AP012/29/2006SLR15593002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021566s002ltr.pdf 1/8/2007
AP05/16/2007SLR16623004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021566s004ltr.pdf 5/29/2007
AP07/31/2009S23177005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021566s005lbl.pdf 8/13/2009
AP07/31/2009S23783005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021566s005ltr.pdf 11/10/2009




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