Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204569

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BELSOMRA (SUVOREXANT)
5MG
Marketing Status: Prescription

Active Ingredient: SUVOREXANT
Proprietary Name: BELSOMRA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204569
Product Number: 001
Approval Date: Aug 13, 2014
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

BELSOMRA (SUVOREXANT)
10MG
Marketing Status: Prescription

Active Ingredient: SUVOREXANT
Proprietary Name: BELSOMRA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204569
Product Number: 002
Approval Date: Aug 13, 2014
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

BELSOMRA (SUVOREXANT)
15MG
Marketing Status: Prescription

Active Ingredient: SUVOREXANT
Proprietary Name: BELSOMRA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204569
Product Number: 003
Approval Date: Aug 13, 2014
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

BELSOMRA (SUVOREXANT)
20MG
Marketing Status: Prescription

Active Ingredient: SUVOREXANT
Proprietary Name: BELSOMRA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204569
Product Number: 004
Approval Date: Aug 13, 2014
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status:  Prescription
Patent and Exclusivity Information