Droperidol

ANDA 70993, held by Abraxis Pharm. Droperidol.

As of Nov 15, 2026, ANDA 70993 (Droperidol), held by Abraxis Pharm, was first approved by FDA on Nov 17, 1986, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 17, 1986
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 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 2 submissions, including labeling and manufacturing supplements


Oct 1, 1991	Supplement 5Labeling	Approved	None posted
Nov 17, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70993
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