Droperidol

ANDA 72335, held by Luitpold. Droperidol.

As of Nov 15, 2026, ANDA 72335 (Droperidol), held by Luitpold, was first approved by FDA on Oct 23, 1988, with 8 approved supplements and 0 published complete response letters.

First approved: Oct 23, 1988
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
Oct 23, 1988	Original application	Approved	None posted

Products

1 strengths and forms

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

All 9 submissions, including labeling and manufacturing supplements


Mar 25, 1999	Supplement 9Manufacturing	Approved	None posted
Oct 13, 1998	Supplement 8Manufacturing	Approved	None posted
Jul 15, 1998	Supplement 7Manufacturing	Approved	None posted
Feb 28, 1996	Supplement 5Manufacturing	Approved	None posted
Mar 8, 1995	Supplement 3Manufacturing	Approved	None posted
Feb 17, 1995	Supplement 6Labeling	Approved	None posted
Oct 11, 1994	Supplement 4Manufacturing	Approved	None posted
Feb 13, 1992	Supplement 1Labeling	Approved	None posted
Oct 23, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 72335
Drugs@FDA: Overview at FDA
Company: Luitpold Pharmaceuticals

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