Bretylium Tosylate In Dextrose 5% In Plastic Container

NDA 19008, held by Hospira Inc. Bretylium Tosylate.

As of Nov 13, 2026, NDA 19008 (Bretylium Tosylate In Dextrose 5% In Plastic Container), held by Hospira Inc, was first approved by FDA on Apr 16, 1986, with 20 approved supplements and 0 published complete response letters.

First approved: Apr 16, 1986
Review: Standard
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Apr 16, 1986	Original applicationNew dosage form · Standard review	Approved	None posted

Products

3 strengths and forms


Bretylium Tosylate In Dextrose 5% In Plastic Container800MG/100ML · injectable;injection	Bretylium Tosylate	Discontinued
Bretylium Tosylate In Dextrose 5% In Plastic Container200MG/100ML · injectable;injection	Bretylium Tosylate	Discontinued
Bretylium Tosylate In Dextrose 5% In Plastic Container400MG/100ML · injectable;injection	Bretylium Tosylate	Discontinued

All 21 submissions, including labeling and manufacturing supplements


Jun 29, 2001	Supplement 21Manufacturing · Standard review	Approved	None posted
Apr 16, 1999	Supplement 19Labeling · Standard review	Approved	None posted
Nov 5, 1998	Supplement 20Manufacturing · Standard review	Approved	None posted
Jun 12, 1997	Supplement 18Manufacturing · Standard review	Approved	None posted
Mar 18, 1997	Supplement 17Manufacturing · Standard review	Approved	None posted
Jun 26, 1996	Supplement 14Manufacturing · Standard review	Approved	None posted
Feb 2, 1996	Supplement 16Manufacturing · Standard review	Approved	None posted
Aug 3, 1995	Supplement 15Manufacturing · Standard review	Approved	None posted
Mar 4, 1994	Supplement 12Labeling · Standard review	Approved	None posted
Dec 31, 1991	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 18, 1991	Supplement 11Manufacturing · Standard review	Approved	None posted
Mar 23, 1990	Supplement 8Manufacturing · Standard review	Approved	None posted
Mar 20, 1990	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 22, 1988	Supplement 7Manufacturing · Standard review	Approved	None posted
Sep 16, 1987	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 26, 1987	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 13, 1987	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 29, 1986	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 24, 1986	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 8, 1986	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 16, 1986	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19008
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