Haloperidol

ANDA 76791, held by Baxter Hlthcare Corp. Haloperidol Lactate.

As of Nov 15, 2026, ANDA 76791 (Haloperidol), held by Baxter Hlthcare Corp, was first approved by FDA on Aug 25, 2004, with 5 approved supplements and 0 published complete response letters.

First approved: Aug 25, 2004
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 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 6 submissions, including labeling and manufacturing supplements


Oct 19, 2011	Supplement 10Labeling	Approved	None posted
Dec 3, 2010	Supplement 9Labeling	Approved	None posted
Aug 19, 2008	Supplement 8Labeling	Approved	None posted
Apr 28, 2008	Supplement 5Labeling	Approved	None posted
Dec 31, 2007	Supplement 4Labeling	Approved	Letter
Aug 25, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 76791
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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