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Details for New Drug Application (NDA): 204569

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NDA 204569 describes BELSOMRA, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the BELSOMRA profile page.

The generic ingredient in BELSOMRA is suvorexant. One supplier is listed for this compound. Additional details are available on the suvorexant profile page.

Summary for NDA: 204569

Tradename:
BELSOMRA
Applicant:
Merck Sharp Dohme
Ingredient:
suvorexant
Patents:1

Suppliers and Packaging for NDA: 204569

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BELSOMRA
suvorexant
TABLET;ORAL 204569 NDA Merck Sharp & Dohme Corp. 0006-0005 0006-0005-13 1 BLISTER PACK in 1 CASE (0006-0005-13) > 3 TABLET, FILM COATED in 1 BLISTER PACK
BELSOMRA
suvorexant
TABLET;ORAL 204569 NDA Merck Sharp & Dohme Corp. 0006-0005 0006-0005-30 3 CASE in 1 CARTON (0006-0005-30) > 1 BLISTER PACK in 1 CASE (0006-0005-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 13, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 13, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:7,951,797Patent Expiration:Nov 20, 2029Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF INSOMNIA

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Aug 13, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 13, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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