← FDA DRUG APPROVALS

FDA NDA · NDA204569

BELSOMRA

suvorexant

Sponsor: MERCK SHARP DOHME

APPLICATION
NDA204569
TYPE
NDA
ORIGINAL APPROVAL
2014-08-13
LATEST ACTION
2025-03-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BELSOMRA · ReferencePrescription
SUVOREXANT 20MG · TABLET · ORAL
BELSOMRA · ReferencePrescription
SUVOREXANT 10MG · TABLET · ORAL
BELSOMRA · ReferencePrescription
SUVOREXANT 15MG · TABLET · ORAL
BELSOMRA · ReferencePrescription
SUVOREXANT 5MG · TABLET · ORAL

Approval history

2025-03-10Labeling · Supplement 10 · standard — Label ↗AP
2021-03-25Labeling · Supplement 8 · standard — Label ↗AP
2020-03-18Labeling · Supplement 7 · standard — Label ↗AP
2020-01-29Efficacy · Supplement 6 · standard — Letter ↗AP
2018-07-12Labeling · Supplement 5 · standard — Label ↗AP
2016-05-27Labeling · Supplement 4 · standard — Letter ↗AP
2016-05-03Manufacturing (CMC) · Supplement 3 · standardAP
2015-04-30Manufacturing (CMC) · Supplement 2 · standardAP
2014-11-07Labeling · Supplement 1 · standard — Letter ↗AP
2014-08-13Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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