Haloperidol

ANDA 71187, held by Abraxis Pharm. Haloperidol Lactate.

As of Nov 15, 2026, ANDA 71187 (Haloperidol), held by Abraxis Pharm, was first approved by FDA on Jan 20, 1987, with 2 approved supplements and 0 published complete response letters.

First approved: Jan 20, 1987
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
Jan 20, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
HaloperidolEQ 5MG BASE/ML · injectable;injection	Haloperidol Lactate	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Nov 29, 1990	Supplement 7Labeling	Approved	None posted
Mar 14, 1988	Supplement 2Labeling	Approved	None posted
Jan 20, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71187
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