Droperidol

ANDA 70992, held by Abraxis Pharm. Droperidol.

As of Nov 15, 2026, ANDA 70992 (Droperidol), held by Abraxis Pharm, was first approved by FDA on Nov 17, 1986, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 17, 1986
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Nov 17, 1986	Original application	Approved	None posted

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Sep 23, 1992	Supplement 3Labeling	Approved	None posted
May 27, 1992	Supplement 10Labeling	Approved	None posted
Sep 22, 1988	Supplement 4Labeling	Approved	None posted
Nov 17, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70992
Drugs@FDA: Overview at FDA
Company: Abraxis 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