Last Updated: November 10, 2026

Details for New Drug Application (NDA): 204386

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NDA 204386 describes BRETYLIUM TOSYLATE, which is a drug marketed by Abraxis Pharm, Astrazeneca, Breckenridge, Hikma, Hospira, Intl Medication, Luitpold, Abbott, B Braun, Baxter Hlthcare, and Hospira Inc, and is included in sixteen NDAs. Additional details are available on the BRETYLIUM TOSYLATE profile page.

The generic ingredient in BRETYLIUM TOSYLATE is bretylium tosylate. There is one drug master file entry for this compound. Additional details are available on the bretylium tosylate profile page.

Summary for 204386

Tradename:	BRETYLIUM TOSYLATE
Applicant:	Breckenridge
Ingredient:	bretylium tosylate
Patents:	0

Medical Subject Heading (MeSH) Categories for 204386

Adrenergic Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	50MG/ML
Approval Date:	Dec 21, 2018	TE:		RLD:	No

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