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FDA Drug Application 202270 by MERCK SHARP DOHME

Application Number202270
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
AP02/2/2012N31662000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202270s000ltr.pdf 2/6/2012
AP02/2/2012N31672000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202270s000lbl.pdf 2/6/2012
AP02/2/2012N31797000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM291878.pdf 2/15/2012
AP02/2/2012N36929000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202270_janumet_xr_toc.cfm 9/3/2013
AP02/2/2012N36930000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202270Orig1s000SumR.pdf 9/3/2013
AP04/10/2013SCM       
AP010/18/2012SLR34137002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202270Orig1s002ltr.pdf 10/22/2012
AP010/18/2012SLR34155002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202270s002lbl.pdf 10/22/2012
AP010/18/2012SLR34156002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202270s002mg.pdf 10/22/2012
AP02/11/2013SLR35138003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202270s003lbl.pdf 2/11/2013
AP02/11/2013SLR35154003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202270Orig1s003ltr.pdf 2/13/2013
AP07/19/2013SCM       
AP010/17/2013SCM       
AP02/12/2014SLR38517006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202270s006lbl.pdf 2/13/2014
AP02/12/2014SLR38519006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202270Orig1s006ltr.pdf 2/13/2014
AP09/19/2014SCM       
AP04/27/2015SLR42692009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s033,022044Orig1s034,202270Orig1s009ltr.pdf 4/29/2015
AP04/27/2015SLR42730009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202270s009lbl.pdf 5/4/2015
AP08/28/2015SLR43769010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s034,022044Orig1s035,202270Orig1s010ltr.pdf 9/1/2015
AP08/28/2015SLR43803010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202270s010lbl.pdf 9/4/2015
AP09/9/2016SCM       




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