Droperidol

ANDA 72019, held by Igi Labs Inc. Droperidol.

As of Nov 15, 2026, ANDA 72019 (Droperidol), held by Igi Labs Inc, was first approved by FDA on Oct 19, 1988, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 19, 1988
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Oct 19, 1988	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Dec 22, 1995	Supplement 3Labeling	Approved	None posted
May 8, 1995	Supplement 2Labeling	Approved	None posted
Oct 19, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 72019
Drugs@FDA: Overview at FDA
Company: IGI Laboratories, Inc.

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