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FDA Drug Application 022518 by MERCK SHARP DOHME

Application Number022518
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
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
AP06/22/2010N25803000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM217561.pdf 6/24/2010
AP06/22/2010N25804000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022518s000lbl.pdf 6/24/2010
AP06/22/2010N25837000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022518s000ltr.pdf 6/29/2010
AP06/22/2010N25873000REMS  http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM217719.pdf 6/30/2010
AP06/22/2010N28943000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022518_dulera_toc.cfm 5/25/2011
AP06/22/2010N28944000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022518Orig1s000SumR.pdf 5/25/2011
AP08/18/2011SLR29832002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022518s002,s004ltr.pdf 8/22/2011
AP08/18/2011SLR29864002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022518s002s004lbl.pdf 8/24/2011
AP08/18/2011SLR29833004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022518s002,s004ltr.pdf 8/22/2011
AP08/18/2011SLR29863004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022518s002s004lbl.pdf 8/24/2011
AP08/21/2012SLR33540005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022518s005lbl.pdf 8/22/2012
AP08/21/2012SLR33541005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022518s005mg.pdf 8/22/2012
AP08/21/2012SLR33544005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022518Orig1s005ltr.pdf 8/23/2012
AP011/13/2012SLR34454006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022518Orig1s006ltr.pdf 11/26/2012
AP011/13/2012SLR34486006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022518s006lbl.pdf 11/28/2012
AP011/27/2012SLR34502007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022518Orig1s007,s010ltr.pdf 11/29/2012
AP01/15/2013SLR34895008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022518Orig1s008ltr.pdf 1/17/2013
AP01/15/2013SLR34918008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022518s008lbl.pdf 1/22/2013
AP01/25/2013SCM       
AP011/27/2012SLR34503010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022518Orig1s007,s010ltr.pdf 11/29/2012
AP07/30/2013SLR36678011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022518Orig1s011ltr.pdf 8/1/2013
AP07/30/2013SLR36748011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022518s011lbl.pdf 8/9/2013
AP06/10/2013SCM       
AP08/21/2013SLR36874013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022518s013lbl.pdf 8/22/2013
AP08/21/2013SLR36878013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022518Orig1s013ltr.pdf 8/22/2013
AP04/17/2014SLR39094014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022518Orig1s014ltr.pdf 4/18/2014
AP04/23/2015SLR42652015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022518s015lbl.pdf 4/24/2015
AP08/6/2015SCM       
AP09/18/2015SCM       
AP012/24/2015SLR44894018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022518Orig1s018ltr.pdf 12/29/2015
AP07/12/2016SE846517019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022518Orig1s019,205641Orig1s005ltr.pdf 7/13/2016
AP07/12/2016SE846521019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022518s019,205641s005lbl.pdf 7/13/2016
AP05/12/2016SCM       




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