Haloperidol Lactate

ANDA 74536, held by Actavis Mid Atlantic. Haloperidol Lactate.

As of Nov 15, 2026, ANDA 74536 (Haloperidol Lactate), held by Actavis Mid Atlantic, was first approved by FDA on Nov 2, 1995, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 2, 1995
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Nov 2, 1995	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Haloperidol LactateEQ 1MG BASE/ML · solution;oral	Haloperidol Lactate	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Feb 23, 2017	Supplement 2Labeling · Standard review	Approved	None posted
Nov 4, 2015	Supplement 1Labeling	Approved	None posted
Nov 2, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74536
Drugs@FDA: Overview at FDA
Company: Actavis Mid Atlantic LLC

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