Dobutrex

NDA 17820, held by Lilly. Dobutamine Hydrochloride.

As of Nov 13, 2026, NDA 17820 (Dobutrex), held by Lilly, was first approved by FDA on Jul 18, 1978, with 32 approved supplements and 0 published complete response letters.

First approved: Jul 18, 1978
Review: Priority
Supplements approved: 32
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 33 submissions below

Date	Submission	Status	Documents
Jul 18, 1978	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
DobutrexEQ 12.5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Dobutamine Hydrochloride	DiscontinuedReference drug

All 33 submissions, including labeling and manufacturing supplements


Jul 23, 2002	Supplement 37Labeling · Priority review	Approved	Letter Review
Jul 29, 1998	Supplement 36Labeling · Priority review	Approved	Review
Jan 8, 1997	Supplement 34Manufacturing · Priority review	Approved	None posted
Mar 6, 1996	Supplement 33Labeling · Priority review	Approved	None posted
Jan 11, 1996	Supplement 31Manufacturing · Priority review	Approved	None posted
Nov 9, 1995	Supplement 32Manufacturing · Priority review	Approved	None posted
Mar 30, 1995	Supplement 29Labeling · Priority review	Approved	None posted
Mar 10, 1995	Supplement 30Manufacturing · Priority review	Approved	None posted
Apr 20, 1994	Supplement 27Labeling · Priority review	Approved	None posted
Feb 9, 1993	Supplement 26Manufacturing · Priority review	Approved	None posted
Feb 1, 1993	Supplement 25Manufacturing · Priority review	Approved	None posted
Apr 26, 1991	Supplement 23Labeling · Priority review	Approved	None posted
Dec 20, 1990	Supplement 24Labeling · Priority review	Approved	None posted
Dec 7, 1989	Supplement 22Labeling · Priority review	Approved	None posted
Jun 23, 1989	Supplement 20Labeling · Priority review	Approved	None posted
Apr 18, 1989	Supplement 21Labeling · Priority review	Approved	None posted
Apr 21, 1988	Supplement 19Labeling · Priority review	Approved	None posted
May 27, 1987	Supplement 18Labeling · Priority review	Approved	None posted
May 27, 1987	Supplement 16Labeling · Priority review	Approved	None posted
Jan 21, 1987	Supplement 17Manufacturing · Priority review	Approved	None posted
Jan 21, 1987	Supplement 15Labeling · Priority review	Approved	None posted
Sep 8, 1986	Supplement 6Labeling · Priority review	Approved	None posted
Mar 7, 1986	Supplement 13Manufacturing · Priority review	Approved	None posted
Mar 7, 1986	Supplement 11Manufacturing · Priority review	Approved	None posted
Jul 25, 1985	Supplement 10Manufacturing · Priority review	Approved	None posted
Jun 24, 1983	Supplement 8Manufacturing · Priority review	Approved	None posted
Feb 24, 1982	Supplement 7Manufacturing · Priority review	Approved	None posted
Jun 17, 1981	Supplement 5Manufacturing · Priority review	Approved	None posted
Feb 3, 1981	Supplement 4Manufacturing · Priority review	Approved	None posted
Aug 13, 1980	Supplement 3Manufacturing · Priority review	Approved	None posted
Sep 12, 1978	Supplement 2Manufacturing · Priority review	Approved	None posted
Sep 12, 1978	Supplement 1Labeling · Priority review	Approved	None posted
Jul 18, 1978	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 17820
Drugs@FDA: Overview at FDA
Company: Lilly

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