Dopamine Hydrochloride

NDA 18132, held by Hospira. Dopamine Hydrochloride.

As of Nov 15, 2026, NDA 18132 (Dopamine Hydrochloride), held by Hospira, was first approved by FDA on May 19, 1981, with 27 approved supplements and 0 published complete response letters.

First approved: May 19, 1981
Supplements approved: 27
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Dopamine HCl 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 28 submissions below

Date	Submission	Status	Documents
May 19, 1981	Original application	Approved	None posted

Products

4 strengths and forms


Dopamine Hydrochloride40MG/ML · injectable;injection	Dopamine Hydrochloride	RxReference drug
Dopamine Hydrochloride80MG/100ML · injectable;injection	Dopamine Hydrochloride	RxReference drug
Dopamine Hydrochloride160MG/100ML · injectable;injection	Dopamine Hydrochloride	RxReference drug
Dopamine Hydrochloride80MG/ML · injectable;injection	Dopamine Hydrochloride	RxReference drug

All 28 submissions, including labeling and manufacturing supplements


Sep 12, 2023	Supplement 71Labeling · Standard review	Approved	Letter Label
May 14, 2014	Supplement 67Labeling · Standard review	Approved	Letter Label
Jul 2, 2008	Supplement 59Labeling	Approved	None posted
Oct 25, 2002	Supplement 51Manufacturing	Approved	None posted
Mar 22, 2001	Supplement 50Manufacturing	Approved	None posted
Mar 22, 2001	Supplement 49Manufacturing	Approved	None posted
Jan 7, 2000	Supplement 48Labeling	Approved	None posted
Jan 7, 2000	Supplement 47Manufacturing	Approved	None posted
Dec 9, 1998	Supplement 46Manufacturing	Approved	None posted
Oct 22, 1996	Supplement 43Manufacturing	Approved	None posted
Oct 3, 1996	Supplement 45Manufacturing	Approved	None posted
Sep 20, 1996	Supplement 40Manufacturing	Approved	None posted
Nov 2, 1995	Supplement 41Manufacturing	Approved	None posted
Jul 15, 1994	Supplement 39Manufacturing	Approved	None posted
Feb 24, 1994	Supplement 38Manufacturing	Approved	None posted
Jan 12, 1993	Supplement 37Labeling	Approved	None posted
Jan 31, 1992	Supplement 36Labeling	Approved	None posted
Jul 2, 1991	Supplement 34Manufacturing	Approved	None posted
Jul 2, 1991	Supplement 33Manufacturing	Approved	None posted
Jun 14, 1991	Supplement 35Labeling	Approved	None posted
Aug 3, 1990	Supplement 32Manufacturing	Approved	None posted
Aug 24, 1989	Supplement 30Labeling	Approved	None posted
Nov 29, 1988	Supplement 29Labeling	Approved	None posted
Mar 7, 1988	Supplement 28Labeling	Approved	None posted
Sep 22, 1987	Supplement 27Labeling	Approved	None posted
Jul 20, 1987	Supplement 26Manufacturing	Approved	None posted
Sep 10, 1984	Supplement 25Manufacturing	Approved	None posted
May 19, 1981	Original application	Approved	None posted

Identifiers

Application: NDA 18132
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