Droperidol

ANDA 72123, held by Am Regent. Droperidol.

As of Nov 15, 2026, ANDA 72123 (Droperidol), held by Am Regent, was first approved by FDA on Oct 24, 1988, with 8 approved supplements and 0 published complete response letters.

First approved: Oct 24, 1988
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Droperidol Injection is indicated to reduce the incidence of nausea and vomiting associated with surgical and diagnostic procedures.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Oct 24, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Droperidol2.5MG/ML · injectable;injection	Droperidol	Rx

All 9 submissions, including labeling and manufacturing supplements


Feb 21, 2023	Supplement 22Labeling · Standard review	Approved	None posted
Jan 10, 2002	Supplement 12Labeling	Approved	None posted
Mar 25, 1999	Supplement 8Manufacturing	Approved	None posted
Jul 2, 1998	Supplement 7Manufacturing	Approved	None posted
Feb 28, 1996	Supplement 4Manufacturing	Approved	None posted
May 26, 1995	Supplement 2Manufacturing	Approved	None posted
Feb 17, 1995	Supplement 5Labeling	Approved	None posted
Oct 11, 1994	Supplement 3Manufacturing	Approved	None posted
Oct 24, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 72123
Drugs@FDA: Overview at FDA
Company: Am Regent

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