Bretylium Tosylate

NDA 19033, held by Hospira. Bretylium Tosylate.

As of Nov 13, 2026, NDA 19033 (Bretylium Tosylate), held by Hospira, was first approved by FDA on Apr 16, 1986, with 7 approved supplements and 0 published complete response letters.

First approved: Apr 16, 1986
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Apr 16, 1986	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Bretylium Tosylate50MG/ML · injectable;injection	Bretylium Tosylate	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Jun 28, 2001	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 26, 1999	Supplement 6Labeling · Standard review	Approved	None posted
Oct 15, 1998	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 7, 1996	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 4, 1994	Supplement 3Labeling · Standard review	Approved	None posted
Aug 20, 1990	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 22, 1988	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 16, 1986	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19033
Drugs@FDA: Overview at FDA
Company: Hospira

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters