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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215025

SODIUM PHENYLACETATE AND SODIUM BENZOATE (SODIUM BENZOATE; SODIUM PHENYLACETATE)
10%;10% (2GM/20ML;2GM/20ML)
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% (2GM/20ML;2GM/20ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N215025
Product Number: 001
Approval Date: Jun 10, 2021
Applicant Holder Full Name: MAIA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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