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FDA Drug Application 022277 by MERCK SHARP DOHME

Application Number022277
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
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
AP02/27/2009N21955000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022277s000ltr.pdf 3/5/2009
AP02/27/2009N22192000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022277lbl.pdf 4/3/2009
AP02/27/2009N24112000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022277_temodar_toc.cfm 11/24/2009
AP02/27/2009N24113000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022277s000_SumR.pdf 11/24/2009
AP04/26/2010SLR25363001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022277s001lbl.pdf 4/28/2010
AP04/26/2010SLR25391001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021029s018,022277s001ltr.pdf 4/29/2010
AP02/4/2011SLR27787004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021029s020,022277s004lbl.pdf 2/9/2011
AP06/3/2011SLR29038005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021029s021,022277s005lbl.pdf 6/7/2011
AP06/3/2011SLR29073005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022277s005,021029s021ltr.pdf 6/9/2011
AP05/5/2014SLR39228007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022277Orig1s007ltr.pdf 5/6/2014
AP05/5/2014SLR39236007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022277s007lbl.pdf 5/6/2014
AP04/2/2015SLR42421008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022277Orig1s008ltr.pdf 4/3/2015
AP04/2/2015SLR42459008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022277s008lbl.pdf 4/7/2015
AP09/18/2015SLR43936009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022277Orig1s009ltr.pdf 9/22/2015
AP09/18/2015SLR43957009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022277s009lbl.pdf 9/23/2015
AP02/12/2016SLR45175011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022277Orig1s011ltr.pdf 2/16/2016
AP02/12/2016SLR45384011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022277s011lbl.pdf 3/4/2016




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