Haloperidol

ANDA 76774, held by Gland Pharma Ltd. Haloperidol Lactate.

As of Nov 15, 2026, ANDA 76774 (Haloperidol), held by Gland Pharma Ltd, was first approved by FDA on Aug 25, 2004, with 4 approved supplements and 0 published complete response letters.

First approved: Aug 25, 2004
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Aug 25, 2004	Original application	Approved	None posted

Products

1 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements


Apr 18, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Jun 8, 2018	Supplement 4Labeling · Standard review	Approved	None posted
Jun 8, 2018	Supplement 5Labeling · Standard review	Approved	None posted
Jun 8, 2018	Supplement 7Labeling · Standard review	Approved	None posted
Aug 25, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 76774
Drugs@FDA: Overview at FDA
Company: Gland Pharma

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