Droperidol

ANDA 71645, held by Hospira. Droperidol.

As of Nov 15, 2026, ANDA 71645 (Droperidol), held by Hospira, was first approved by FDA on Apr 7, 1988, with 2 approved supplements and 0 published complete response letters.

First approved: Apr 7, 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
Apr 7, 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


Mar 3, 1995	Supplement 2Labeling	Approved	None posted
Jan 27, 1995	Supplement 1Manufacturing	Approved	None posted
Apr 7, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 71645
Drugs@FDA: Overview at FDA
Company: Hospira

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