suvorexant Oral Tablet

Brand(s)
Belsomra
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Merck Sharp & Dohme Corp. (2015-08-12)
Oldest Current Product
2014-08-29
License(s)
NDA
RxNORM
ORAL TABLET\SUVOREXANT
FDAOB
ORAL\TABLET\SUVOREXANT
SPL Active
ORAL\TABLET, FILM COATED\SUVOREXANT
SPL Moiety
ORAL\TABLET, FILM COATED\SUVOREXANT

product(s) by strength(s)

suvorexant 10 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000060033BelsomraNDAMerck Sharp & Dohme Corp.2014-08-29SUVOREXANTORALTABLET, FILM COATEDNDA204569e5b72731-1acb-45b7-9c13-290ad12d3951

suvorexant 15 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000060325BelsomraNDAMerck Sharp & Dohme Corp.2014-08-29SUVOREXANTORALTABLET, FILM COATEDNDA204569e5b72731-1acb-45b7-9c13-290ad12d3951

suvorexant 20 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000060335BelsomraNDAMerck Sharp & Dohme Corp.2014-08-29SUVOREXANTORALTABLET, FILM COATEDNDA204569e5b72731-1acb-45b7-9c13-290ad12d3951

suvorexant 5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000060005BelsomraNDAMerck Sharp & Dohme Corp.2014-08-29SUVOREXANTORALTABLET, FILM COATEDNDA204569e5b72731-1acb-45b7-9c13-290ad12d3951

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA204569BELSOMRAMERCK SHARP AND DOHME CORP2014-08-13p7951797, TREATMENT OF INSOMNIA, SUBSTANCENEW CHEMICAL ENTITY [2019-08-13]NDA204569_001, NDA204569_002, NDA204569_003, NDA204569_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204569_001RXSUVOREXANT (5MG)ORALTABLETFalse2014-08-13BELSOMRA
2NDA204569_002RXSUVOREXANT (10MG)ORALTABLETFalse2014-08-13BELSOMRA
3NDA204569_003RXSUVOREXANT (15MG)ORALTABLETFalse2014-08-13BELSOMRA
4NDA204569_004RXSUVOREXANT (20MG)ORALTABLETTrue2014-08-13BELSOMRA

patent(s)

#idexpiration dateapplication(s)
1p7951797 (view patent)2029-11-20NDA204569

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1e5b72731-1acb-45b7-9c13-290ad12d3951 (view SPL)These highlights do not include all the information needed to use BELSOMRA safely and effectively. See full prescribing information for BELSOMRA. BELSOMRA (suvorexant) tablets, for oral use, C-IV Initial U.S. Approval: 2014prescriptionHuman PrescriptionMerck Sharp & Dohme Corp.2015-08-124000060005, 000060033, 000060325, 000060335

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII