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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 205880

SODIUM PHENYLACETATE AND SODIUM BENZOATE (SODIUM BENZOATE; SODIUM PHENYLACETATE)
10%;10% (5GM/50ML;5GM/50ML)
Marketing Status: Prescription
Active Ingredient: SODIUM BENZOATE; SODIUM PHENYLACETATE
Proprietary Name: SODIUM PHENYLACETATE AND SODIUM BENZOATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 10%;10% (5GM/50ML;5GM/50ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A205880
Product Number: 001
Approval Date: Aug 4, 2016
Applicant Holder Full Name: NAVINTA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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