sodium benzoate

Generic Name: sodium benzoate

Overview

No overview information available.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Efficacy and Safety of Sodium Benzoate in the Management of Hyperammonemia in Infants, Children and Adolescent With Chronic Liver Disease.	2019/07/17	NCT04022941	Not Applicable	Completed	Institute of Liver and Biliary Sciences, India
Sodium Benzoate and/or N-Acetylcysteine Added to TAU in Patients With Early Schizophrenia Spectrum Disorder.	2018/04/27	NCT03510741	Phase 2	Completed	Pakistan Institute of Living and Learning
An Adaptive Phase II/III, Two-Part, Double-Blind, Randomized, Placebo-controlled, Dose-Finding, Multi-center Study of the Safety and Efficacy of NaBen®, as an Add-on Therapy With Clozapine, for Residual Symptoms of Refractory Schizophrenia in Adults	2017/03/29	NCT03094429	Phase 2	Recruiting	SyneuRx International (Taiwan) Corp
Study to Evaluate Safety & Efficacy of NaBen® as Add-on Treatment for Schizophrenia in Adults	2014/10/10	NCT02261519	Phase 2	Terminated	SyneuRx International (Taiwan) Corp
Comparative Efficacy of Phenylbutyrate (PBA) vs. Benzoate in Urea Cycle Disorders	2014/04/11	NCT02111200	Not Applicable	Completed	Baylor College of Medicine
Sodium Benzoate for Treatment of Attenuated/Transient Psychosis. A Randomized Placebo-controlled Trial.	2014/01/03	NCT02026947	Phase 2	Withdrawn	Niuvanniemi Hospital
Adaptive Phase II Study to Evaluate the Safety & Efficacy of NaBen®	2013/07/25	NCT01908192	Phase 2	Terminated	SyneuRx International (Taiwan) Corp
Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle Disorders	2000/02/25	NCT00004767	Phase 2	Completed	National Center for Research Resources (NCRR)

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Sodium Phenylacetate and Sodium Benzoate	MAIA PHARMACEUTICALS	70511-102	INTRAVENOUS	100 mg in 1 mL	6/24/2021
SODIUM PHENYLACETATE AND SODIUM BENZOATE	Oceanside Pharmaceuticals	68682-001	INTRAVENOUS	100 mg in 1 mL	12/1/2020
Sodium Phenylacetate and Sodium Benzoate	Mylan Institutional LLC	67457-844	INTRAVENOUS	100 mg in 1 mL	3/16/2021
SODIUM PHENYLACETATE and SODIUM BENZOATE	Woodward Pharma Services LLC	69784-811	INTRAVENOUS	100 mg in 1 mL	12/15/2021
Ammonul	Bausch Health US LLC	0187-0010	INTRAVENOUS	100 mg in 1 mL	12/1/2020
SODIUM PHENYLACETATE and SODIUM BENZOATE	Ailex Pharmaceuticals, LLC	70556-100	INTRAVENOUS	100 mg in 1 mL	4/20/2018
Sodium phenylacetate and Sodium benzoate	Zydus Pharmaceuticals USA Inc.	70710-1926	INTRAVENOUS	100 mg in 1 mL	10/30/2023
Sodium Phenylacetate and sodium benzoate	Navinta LLC	68475-001	INTRAVENOUS	100 mg in 1 mL	12/2/2022
Ammonul	Ucyclyd Pharma Inc.	62592-720	INTRAVENOUS	100 mg in 1 mL	1/12/2018
Sodium Phenylacetate and Sodium Benzoate	FOSUN PHARMA USA INC	72266-236	INTRAVENOUS	100 mg in 1 mL	10/21/2021

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
WEILI ENEMAS	N/A	EEC MARKETING	N/A	N/A	12/9/1985

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
LISTERINE TEETH DEFENCE ANTISEPTIC MOUTHWASH bottle (reformulation)	201303	Johnson & Johnson Pacific Pty Ltd	Medicine	A	9/25/2012
LISTERINE TOTAL CARE ANTISEPTIC MOUTHWASH bottle	178347	Johnson & Johnson Pacific Pty Ltd	Medicine	A	12/13/2010
LISTERINE TOTAL CARE SENSITIVE ANTISEPTIC MOUTHWASH bottle	178257	Johnson & Johnson Pacific Pty Ltd	Medicine	A	12/9/2010
LISTERINE ANTISEPTIC MOUTHWASH oral liquid bottle	60888	Johnson & Johnson Pacific Pty Ltd	Medicine	A	8/21/1997
LISTERINE FRESHBURST ANTISEPTIC MOUTHWASH bottle (reformulation)	201302	Johnson & Johnson Pacific Pty Ltd	Medicine	A	9/25/2012
LISTERINE TARTAR CONTROL ANTISEPTIC MOUTHWASH bottle (reformulation)	201304	Johnson & Johnson Pacific Pty Ltd	Medicine	A	9/25/2012
LISTERINE TOTAL CARE SENSITIVE ANTISEPTIC MOUTHWASH	315552	Johnson & Johnson Pacific Pty Ltd	Medicine	A	3/19/2019
LISTERINE COOLMINT ANTISEPTIC MOUTHWASH bottle (reformulation)	201301	Johnson & Johnson Pacific Pty Ltd	Medicine	A	9/25/2012

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PLAX ANTI-PLAQUE DENTAL RINSE	johnson & johnson inc	01942506	Liquid - Dental	2 %	12/31/1988
GLYCOTHYMOLINE	glendale agencies	00110760	Liquid - Topical	20 MG / ML	12/31/1951

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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