Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 217369

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ZURZUVAE (ZURANOLONE)
20MG
Marketing Status: Prescription

Active Ingredient: ZURANOLONE
Proprietary Name: ZURZUVAE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N217369
Product Number: 001
Approval Date: Oct 31, 2023
Applicant Holder Full Name: BIOGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ZURZUVAE (ZURANOLONE)
25MG
Marketing Status: Prescription

Active Ingredient: ZURANOLONE
Proprietary Name: ZURZUVAE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N217369
Product Number: 002
Approval Date: Oct 31, 2023
Applicant Holder Full Name: BIOGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ZURZUVAE (ZURANOLONE)
30MG
Marketing Status: Prescription

Active Ingredient: ZURANOLONE
Proprietary Name: ZURZUVAE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N217369
Product Number: 003
Approval Date: Oct 31, 2023
Applicant Holder Full Name: BIOGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information