SODIUM PHENYLACETATE AND SODIUM BENZOATE

Zydus Pharmaceuticals USA Inc.🇺🇸 United States

FDA Page

Effective Date: Dec 2, 2022
Approval ID: 204e84a7-5440-4537-9e40-06eb56c415e9
Products: 1 registered
Version: 6

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use Sodium Phenylacetate and Sodium Benzoate Injection 10% / 10% safely and effectively. See full prescribing information for Sodium Phenylacetate and Sodium Benzoate Injection 10% / 10% Sodium Phenylacetate and Sodium Benzoate Injection 10% / 10%, for intravenous useInitial U.S. Approval:1987

Quick Stats

Total Products1

Labelers2

Label Sections31

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.