Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212028

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DAYVIGO (LEMBOREXANT)
5MG
Marketing Status: Prescription

Active Ingredient: LEMBOREXANT
Proprietary Name: DAYVIGO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212028
Product Number: 001
Approval Date: Apr 7, 2020
Applicant Holder Full Name: EISAI INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DAYVIGO (LEMBOREXANT)
10MG
Marketing Status: Prescription

Active Ingredient: LEMBOREXANT
Proprietary Name: DAYVIGO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212028
Product Number: 002
Approval Date: Apr 7, 2020
Applicant Holder Full Name: EISAI INC
Marketing Status:  Prescription
Patent and Exclusivity Information