Dopamine Hydrochloride In Dextrose 5% In Plastic Container

NDA 18826, held by Hospira. Dopamine Hydrochloride.

As of Nov 13, 2026, NDA 18826 (Dopamine Hydrochloride In Dextrose 5% In Plastic Container), held by Hospira, was first approved by FDA on Sep 30, 1983, with 30 approved supplements and 0 published complete response letters.

First approved: Sep 30, 1983
Review: Standard
Supplements approved: 30
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Dopamine Hydrochloride in Dextrose Injection is indicated to improve hemodynamic status in patients in distributive shock, or shock due to reduced cardiac output.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 31 submissions below

Date	Submission	Status	Documents
Sep 30, 1983	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

3 strengths and forms


Dopamine Hydrochloride In Dextrose 5% In Plastic Container80MG/100ML · injectable;injection	Dopamine Hydrochloride	RxReference drug
Dopamine Hydrochloride In Dextrose 5% In Plastic Container160MG/100ML · injectable;injection	Dopamine Hydrochloride	RxReference drug
Dopamine Hydrochloride In Dextrose 5% In Plastic Container320MG/100ML · injectable;injection	Dopamine Hydrochloride	RxReference drug

All 31 submissions, including labeling and manufacturing supplements


Jun 4, 2025	Supplement 51Labeling · Standard review	Approved	Label Letter
Apr 30, 2021	Supplement 47Labeling · Standard review	Approved	Label Letter
May 14, 2014	Supplement 45Labeling · Standard review	Approved	Letter Label
Dec 16, 2013	Supplement 44Manufacturing · Standard review	Approved	None posted
Nov 5, 2002	Supplement 28Manufacturing · Standard review	Approved	None posted
Apr 10, 2001	Supplement 27Labeling · Standard review	Approved	Review Letter
Jun 5, 1999	Supplement 26Labeling · Standard review	Approved	None posted
Nov 16, 1998	Supplement 25Manufacturing · Standard review	Approved	None posted
Apr 8, 1998	Supplement 23Labeling · Standard review	Approved	None posted
Sep 7, 1997	Supplement 24Manufacturing · Standard review	Approved	None posted
Jun 26, 1996	Supplement 20Manufacturing · Standard review	Approved	None posted
Aug 17, 1995	Supplement 19Manufacturing · Standard review	Approved	None posted
Aug 3, 1995	Supplement 22Manufacturing · Standard review	Approved	None posted
Apr 14, 1995	Supplement 21Labeling · Standard review	Approved	None posted
Jul 7, 1994	Supplement 18Labeling · Standard review	Approved	None posted
Jun 14, 1994	Supplement 17Manufacturing · Standard review	Approved	None posted
May 7, 1992	Supplement 16Labeling	Approved	None posted
Dec 31, 1991	Supplement 15Manufacturing · Standard review	Approved	None posted
Jul 18, 1991	Supplement 14Manufacturing · Standard review	Approved	None posted
Nov 15, 1990	Supplement 13Manufacturing · Standard review	Approved	None posted
Jul 25, 1990	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 13, 1987	Supplement 10Labeling	Approved	None posted
Oct 29, 1986	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 24, 1986	Supplement 8Manufacturing · Standard review	Approved	None posted
Apr 1, 1986	Supplement 7Manufacturing · Standard review	Approved	None posted
Sep 18, 1984	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 18, 1984	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 27, 1984	Supplement 2Manufacturing · Standard review	Approved	None posted
Jan 4, 1984	Supplement 3Manufacturing · Standard review	Approved	None posted
Jan 4, 1984	Supplement 1Manufacturing · Standard review	Approved	None posted
Sep 30, 1983	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18826
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