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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203284

RAVICTI (GLYCEROL PHENYLBUTYRATE)
1.1GM/ML
Marketing Status: Prescription
Active Ingredient: GLYCEROL PHENYLBUTYRATE
Proprietary Name: RAVICTI
Dosage Form; Route of Administration: LIQUID; ORAL
Strength: 1.1GM/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203284
Product Number: 001
Approval Date: Feb 1, 2013
Applicant Holder Full Name: HORIZON THERAPEUTICS US HOLDING LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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