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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020645

AMMONUL (SODIUM BENZOATE; SODIUM PHENYLACETATE)
10%;10% (5GM/50ML;5GM/50ML)
Marketing Status: Prescription
Active Ingredient: SODIUM BENZOATE; SODIUM PHENYLACETATE
Proprietary Name: AMMONUL
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 10%;10% (5GM/50ML;5GM/50ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N020645
Product Number: 001
Approval Date: Feb 17, 2005
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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