Haloperidol Decanoate

Treats schizophrenia. ANDA 75440, held by Mylan Labs Ltd. Haloperidol Decanoate.

As of Nov 14, 2026, ANDA 75440 (Haloperidol Decanoate), held by Mylan Labs Ltd, was first approved by FDA on Feb 28, 2000, with 22 approved supplements and 0 published complete response letters.

First approved: Feb 28, 2000
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Haloperidol decanoate injection is indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate-release oral haloperidol product.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Feb 28, 2000	Original application	Approved	Review Letter

Products

2 strengths and forms


Haloperidol DecanoateEQ 50MG BASE/ML · injectable;injection	Haloperidol Decanoate	Rx
Haloperidol DecanoateEQ 100MG BASE/ML · injectable;injection	Haloperidol Decanoate	Rx

All 23 submissions, including labeling and manufacturing supplements


Aug 18, 2025	Supplement 55Labeling · Standard review	Approved	None posted
Aug 23, 2021	Supplement 49Labeling · Standard review	Approved	None posted
Dec 23, 2019	Supplement 45Labeling · Standard review	Approved	None posted
Dec 23, 2019	Supplement 41Labeling · Standard review	Approved	None posted
Dec 23, 2019	Supplement 40Labeling · Standard review	Approved	None posted
Sep 19, 2016	Supplement 39Labeling · Standard review	Approved	None posted
Sep 19, 2016	Supplement 36Labeling · Standard review	Approved	None posted
Nov 30, 2011	Supplement 32Labeling	Approved	None posted
Feb 26, 2010	Supplement 31Labeling	Approved	None posted
Jan 29, 2009	Supplement 30Labeling	Approved	None posted
Aug 19, 2008	Supplement 29Labeling	Approved	None posted
Apr 28, 2008	Supplement 26Labeling	Approved	None posted
Dec 31, 2007	Supplement 23Labeling	Approved	Letter
Feb 9, 2007	Supplement 21Labeling	Approved	None posted
Feb 11, 2005	Supplement 13Labeling	Approved	None posted
Feb 11, 2005	Supplement 12	Approved	None posted
Feb 11, 2005	Supplement 11	Approved	None posted
Feb 11, 2005	Supplement 10	Approved	None posted
Nov 26, 2002	Supplement 5Manufacturing	Approved	None posted
Jun 24, 2002	Supplement 3Manufacturing	Approved	None posted
Jan 2, 2002	Supplement 4Manufacturing	Approved	None posted
Nov 19, 2001	Supplement 1Labeling	Approved	None posted
Feb 28, 2000	Original application	Approved	Review Letter

Identifiers

Application: ANDA 75440
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