Haloperidol

ANDA 76035, held by Teva Pharms USA. Haloperidol Lactate.

As of Nov 15, 2026, ANDA 76035 (Haloperidol), held by Teva Pharms USA, was first approved by FDA on Aug 29, 2001, with 9 approved supplements and 0 published complete response letters.

First approved: Aug 29, 2001
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Aug 29, 2001	Original application	Approved	Letter

Products

1 strengths and forms

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

All 10 submissions, including labeling and manufacturing supplements


Jan 22, 2025	Supplement 27Labeling · Standard review	Approved	None posted
Jan 13, 2025	Supplement 26Labeling · Standard review	Approved	None posted
Jun 8, 2018	Supplement 24Labeling · Standard review	Approved	None posted
Jun 8, 2018	Supplement 23Labeling · Standard review	Approved	None posted
Sep 11, 2015	Supplement 21Labeling · Standard review	Approved	None posted
Jan 3, 2012	Supplement 14Labeling	Approved	None posted
Oct 14, 2011	Supplement 6Labeling	Approved	None posted
Dec 3, 2010	Supplement 9Labeling	Approved	None posted
Apr 30, 2009	Supplement 4Labeling	Approved	None posted
Aug 29, 2001	Original application	Approved	Letter

Identifiers

Application: ANDA 76035
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals USA

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