Haloperidol

ANDA 70714, held by Watson Labs. Haloperidol Lactate.

As of Nov 15, 2026, ANDA 70714 (Haloperidol), held by Watson Labs, was first approved by FDA on May 17, 1988, with 4 approved supplements and 0 published complete response letters.

First approved: May 17, 1988
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
May 17, 1988	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


Nov 3, 2015	Supplement 6Labeling	Approved	None posted
Sep 11, 1990	Supplement 4Manufacturing	Approved	None posted
Dec 22, 1989	Supplement 3Labeling	Approved	None posted
Feb 9, 1989	Supplement 1Manufacturing	Approved	None posted
May 17, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 70714
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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