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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020573

BUPHENYL (SODIUM PHENYLBUTYRATE)
3GM/TEASPOONFUL
Marketing Status: Prescription
Active Ingredient: SODIUM PHENYLBUTYRATE
Proprietary Name: BUPHENYL
Dosage Form; Route of Administration: POWDER; ORAL
Strength: 3GM/TEASPOONFUL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020573
Product Number: 001
Approval Date: Apr 30, 1996
Applicant Holder Full Name: HORIZON THERAPEUTICS US HOLDING LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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