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FDA Drug Application 022020 by WYETH PHARMS INC

Application Number022020
Application Type New Drug Application
Sponsor ApplicantWYETH PHARMS 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
AP011/14/2007N18426000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022020lbl.pdf 11/19/2007
AP011/14/2007N18461000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022020s000ltr.pdf 11/19/2007
AP011/14/2007N22135000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022020s000_SumR.pdf 3/31/2009
AP011/14/2007N22136000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022020_protonix_toc.cfm 3/31/2009
AP011/14/2007N31076000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm 12/20/2011
AP011/14/2007N34113000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM324058.pdf 10/16/2012
AP011/12/2009SLR23895002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022020s002,020987s036s037lbl.pdf 11/16/2009
AP011/12/2009SLR24148002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022020s002,020987s036,s037ltr.pdf 11/25/2009
AP09/3/2010SLR26429003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020987s038,022020s003ltr.pdf 9/8/2010
AP09/3/2010SLR26460003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020987s038,022020s003lbl.pdf 9/10/2010
AP010/31/2011SLR30432004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022020s004,020987s039ltr.pdf 10/31/2011
AP010/31/2011SLR30455004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022020s004,020987s039lbl.pdf 11/1/2011
AP05/20/2011SLR28930005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020987s041,022020s005ltr.pdf 5/25/2011
AP05/20/2011SLR28955005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020987s041,022020s005lbl.pdf 5/25/2011
AP010/9/2012SLR34029006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020987Orig1s043,022020Orig1s006ltr.pdf 10/11/2012
AP010/9/2012SLR34105006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020987s043,022020s006lbl.pdf 10/15/2012
AP05/11/2012SLR32688007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022020s007lbl.pdf 5/15/2012
AP012/10/2013SLR37999010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020987s048,022020s010lbl.pdf 12/11/2013
AP012/10/2013SLR38033010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020987Orig1s048,022020Orig1s010ltr.pdf 12/13/2013
AP012/19/2014SLR41387011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022020Orig1s011,020987Orig1s049ltr.pdf 12/24/2014
AP012/19/2014SLR41412011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022020s011-020987s049lbl.pdf 12/29/2014
AP010/24/2016SLR47530012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020987s050,022020s012lbl.pdf 10/31/2016
AP010/24/2016SLR47454020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020987Orig1s050,022020Orig1s012ltr.pdf 10/26/2016




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