FDA Drug Application 205596 by MERCK SHARP DOHME

Application Number	205596
Application Type	New Drug Application
Sponsor Applicant	MERCK SHARP DOHME
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New formulation
Therapeutic Potential	Priority
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	3/13/2014	N	38796	000	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205596Orig1s000ltr.pdf	3/14/2014
AP	3/13/2014	N	38849	000	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205596s000lbl.pdf	3/19/2014
AP	3/13/2014	N	40749	000	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205596Orig1s000TOC.cfm	10/10/2014
AP	3/13/2014	N	40750	000	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205596Orig1s000SumR.pdf	10/10/2014
AP	11/16/2015	SLR	44504	001	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s018,s020,205053Orig1s002,s004,205596Orig1s001,s003ltr.pdf	11/18/2015
AP	11/16/2015	SLR	44537	001	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf	11/19/2015
AP	11/16/2015	SLR	44505	003	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s018,s020,205053Orig1s002,s004,205596Orig1s001,s003ltr.pdf	11/18/2015
AP	11/16/2015	SLR	44538	003	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf	11/19/2015
AP	9/9/2016	SLR	47030	004	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022003s021,205053s005,205596s004lbl.pdf	9/12/2016
AP	9/9/2016	SLR	47042	004	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022003Orig1s021,205053Orig1s005,205596Orig1s004ltr.pdf	9/15/2016

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