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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 217026

DAYBUE (TROFINETIDE)
200MG/ML
Marketing Status: Prescription
Active Ingredient: TROFINETIDE
Proprietary Name: DAYBUE
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 200MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N217026
Product Number: 001
Approval Date: Mar 10, 2023
Applicant Holder Full Name: ACADIA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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