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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211371

ZULRESSO (BREXANOLONE)
100MG/20ML (5MG/ML)
Marketing Status: Prescription
Active Ingredient: BREXANOLONE
Proprietary Name: ZULRESSO
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 100MG/20ML (5MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211371
Product Number: 001
Approval Date: Jun 17, 2019
Applicant Holder Full Name: SAGE THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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