Dobutamine Hydrochloride In Dextrose 5%

NDA 20269, held by Hospira. Dobutamine Hydrochloride.

As of Nov 14, 2026, NDA 20269 (Dobutamine Hydrochloride In Dextrose 5%), held by Hospira, was first approved by FDA on Sep 27, 1993, with 5 approved supplements and 0 published complete response letters.

First approved: Sep 27, 1993
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Sep 27, 1993	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

3 strengths and forms


Dobutamine Hydrochloride In Dextrose 5%EQ 50MG BASE/100ML · injectable;injection	Dobutamine Hydrochloride	Discontinued
Dobutamine Hydrochloride In Dextrose 5%EQ 100MG BASE/100ML · injectable;injection	Dobutamine Hydrochloride	Discontinued
Dobutamine Hydrochloride In Dextrose 5%EQ 200MG BASE/100ML · injectable;injection	Dobutamine Hydrochloride	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Feb 17, 1999	Supplement 6Labeling · Standard review	Approved	None posted
Jul 17, 1996	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 3, 1995	Supplement 5Manufacturing · Standard review	Approved	None posted
May 19, 1994	Supplement 1Labeling · Standard review	Approved	None posted
Feb 24, 1994	Supplement 2Manufacturing · Standard review	Approved	None posted
Sep 27, 1993	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 20269
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