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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214985

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QUVIVIQ (DARIDOREXANT HYDROCHLORIDE)
EQ 25MG BASE
Marketing Status: Prescription
Active Ingredient: DARIDOREXANT HYDROCHLORIDE
Proprietary Name: QUVIVIQ
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214985
Product Number: 001
Approval Date: Apr 7, 2022
Applicant Holder Full Name: IDORSIA PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
QUVIVIQ (DARIDOREXANT HYDROCHLORIDE)
EQ 50MG BASE
Marketing Status: Prescription
Active Ingredient: DARIDOREXANT HYDROCHLORIDE
Proprietary Name: QUVIVIQ
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214985
Product Number: 002
Approval Date: Apr 7, 2022
Applicant Holder Full Name: IDORSIA PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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