Haloperidol Intensol

ANDA 72045, held by Hikma. Haloperidol Lactate.

As of Nov 15, 2026, ANDA 72045 (Haloperidol Intensol), held by Hikma, was first approved by FDA on Apr 12, 1988, with 2 approved supplements and 0 published complete response letters.

First approved: Apr 12, 1988
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
Apr 12, 1988	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Feb 26, 1990	Supplement 5Labeling	Approved	None posted
Sep 13, 1988	Supplement 2Labeling	Approved	None posted
Apr 12, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 72045
Drugs@FDA: Overview at FDA
Company: Hikma

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