Haloperidol

ANDA 71617, held by Teva Pharms. Haloperidol Lactate.

As of Nov 15, 2026, ANDA 71617 (Haloperidol), held by Teva Pharms, was first approved by FDA on Dec 1, 1988, with 24 approved supplements and 0 published complete response letters.

First approved: Dec 1, 1988
Supplements approved: 24
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Dec 1, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
HaloperidolEQ 2MG BASE/ML · concentrate;oral	Haloperidol Lactate	Discontinued

All 25 submissions, including labeling and manufacturing supplements


Jan 22, 2025	Supplement 34Labeling · Standard review	Approved	None posted
Feb 23, 2017	Supplement 32Labeling · Standard review	Approved	None posted
Dec 3, 2010	Supplement 28Labeling	Approved	None posted
May 26, 2009	Supplement 27Labeling	Approved	None posted
Nov 19, 2008	Supplement 26Labeling	Approved	None posted
Aug 19, 2008	Supplement 25Labeling	Approved	None posted
Jan 23, 2002	Supplement 13Manufacturing	Approved	None posted
Oct 31, 2001	Supplement 19Manufacturing	Approved	None posted
Oct 31, 2001	Supplement 18Manufacturing	Approved	None posted
Oct 31, 2001	Supplement 17Manufacturing	Approved	None posted
Oct 25, 2001	Supplement 16Manufacturing	Approved	None posted
Oct 25, 2001	Supplement 15Manufacturing	Approved	None posted
Oct 25, 2001	Supplement 14Manufacturing	Approved	None posted
Feb 26, 2001	Supplement 12Manufacturing	Approved	None posted
Oct 27, 2000	Supplement 11Manufacturing	Approved	None posted
Jun 17, 1999	Supplement 9Manufacturing	Approved	None posted
May 13, 1999	Supplement 7Manufacturing	Approved	None posted
Mar 23, 1999	Supplement 8Manufacturing	Approved	None posted
Dec 7, 1998	Supplement 6Manufacturing	Approved	None posted
Jun 2, 1997	Supplement 5Labeling	Approved	None posted
May 31, 1996	Supplement 4Manufacturing	Approved	None posted
Jan 29, 1993	Supplement 3Manufacturing	Approved	None posted
Oct 21, 1992	Supplement 1Manufacturing	Approved	None posted
Oct 10, 1991	Supplement 2Labeling	Approved	None posted
Dec 1, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 71617
Drugs@FDA: Overview at FDA
Company: Teva 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