Dopamine Hydrochloride

NDA 18398, held by Baxter Hlthcare. Dopamine Hydrochloride.

As of Nov 14, 2026, NDA 18398 (Dopamine Hydrochloride), held by Baxter Hlthcare, was first approved by FDA on Jul 6, 1981, with 8 approved supplements and 0 published complete response letters.

First approved: Jul 6, 1981
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jul 6, 1981	Original application	Approved	None posted

Products

2 strengths and forms


Dopamine Hydrochloride40MG/ML · injectable;injection	Dopamine Hydrochloride	Discontinued
Dopamine Hydrochloride80MG/ML · injectable;injection	Dopamine Hydrochloride	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Aug 4, 1998	Supplement 24Manufacturing	Approved	None posted
Feb 27, 1998	Supplement 23Labeling	Approved	None posted
Oct 17, 1997	Supplement 22Manufacturing	Approved	None posted
Jul 30, 1996	Supplement 21Labeling	Approved	None posted
Jul 29, 1991	Supplement 19Labeling	Approved	None posted
Apr 28, 1987	Supplement 14Manufacturing	Approved	None posted
Apr 28, 1987	Supplement 16Manufacturing	Approved	None posted
Jun 17, 1985	Supplement 11Manufacturing	Approved	None posted
Jul 6, 1981	Original application	Approved	None posted

Identifiers

Application: NDA 18398
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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