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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 070546

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NDA 070546 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 are three drug master file entries for this compound. Additional details are available on the bretylium tosylate profile page.

Summary for 070546

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

Medical Subject Heading (MeSH) Categories for 070546

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:	May 14, 1986	TE:		RLD:	No

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