Haloperidol

Treats schizophrenia. ANDA 78347, held by Mylan Labs Ltd. Haloperidol Lactate.

As of Nov 15, 2026, ANDA 78347 (Haloperidol), held by Mylan Labs Ltd, was first approved by FDA on Sep 14, 2009, with 7 approved supplements and 0 published complete response letters.

First approved: Sep 14, 2009
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Haloperidol injection is indicated for the treatment of patients with schizophrenia.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Sep 14, 2009	Original application	Approved	None posted

Products

1 strengths and forms

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

All 8 submissions, including labeling and manufacturing supplements


Jan 22, 2025	Supplement 22Labeling · Standard review	Approved	None posted
Jan 16, 2025	Supplement 16Labeling · Standard review	Approved	None posted
Oct 9, 2019	Supplement 13Labeling · Standard review	Approved	None posted
Jun 8, 2018	Supplement 7Labeling · Standard review	Approved	None posted
Jun 8, 2018	Supplement 8Labeling · Standard review	Approved	None posted
Jun 8, 2018	Supplement 11Labeling · Standard review	Approved	None posted
Dec 3, 2010	Supplement 1Labeling	Approved	None posted
Sep 14, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78347
Drugs@FDA: Overview at FDA
Company: Mylan 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