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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216513

PHEBURANE (SODIUM PHENYLBUTYRATE)
84GM/BOT
Marketing Status: Prescription
Active Ingredient: SODIUM PHENYLBUTYRATE
Proprietary Name: PHEBURANE
Dosage Form; Route of Administration: PELLETS; ORAL
Strength: 84GM/BOT
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216513
Product Number: 001
Approval Date: Jun 17, 2022
Applicant Holder Full Name: MEDUNIK CANADA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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