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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204569
Company: MERCK SHARP DOHME

Medication Guide

Summary Review

Products on NDA 204569

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BELSOMRA	SUVOREXANT	5MG	TABLET;ORAL	Prescription	None	Yes	No
BELSOMRA	SUVOREXANT	10MG	TABLET;ORAL	Prescription	None	Yes	No
BELSOMRA	SUVOREXANT	15MG	TABLET;ORAL	Prescription	None	Yes	No
BELSOMRA	SUVOREXANT	20MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204569

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/13/2014	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204569s000lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204569Orig1s000rltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204569Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204569Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/25/2021	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204569s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204569Orig1s008ltr.pdf
03/18/2020	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204569Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204569Orig1s007ltr.pdf
01/29/2020	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204569s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204569Orig1s006ltr.pdf
07/12/2018	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204569s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204569Orig1s005ltr.pdf
05/27/2016	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204569Orig1s004ltr.pdf
05/03/2016	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/30/2015	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
11/07/2014	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204569s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204569Orig1s001ltr.pdf

Labels for NDA 204569

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/25/2021	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204569s008lbl.pdf
03/18/2020	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204569Orig1s007lbl.pdf
01/29/2020	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204569s006lbl.pdf
07/12/2018	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204569s005lbl.pdf
11/07/2014	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204569s001lbl.pdf
08/13/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204569s000lbledt.pdf

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