Haloperidol Decanoate

Treats schizophrenia. ANDA 205241, held by Gland. Haloperidol Decanoate.

As of Nov 15, 2026, ANDA 205241 (Haloperidol Decanoate), held by Gland, was first approved by FDA on May 12, 2017, with 5 approved supplements and 0 published complete response letters.

First approved: May 12, 2017
Review: Standard
Supplements approved: 5
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 6 submissions below

Date	Submission	Status	Documents
May 12, 2017	Original application	Approved	None posted

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 6 submissions, including labeling and manufacturing supplements


Sep 23, 2026	Supplement 8Labeling · Standard review	Approved	None posted
Apr 24, 2025	Supplement 7Labeling · Standard review	Approved	None posted
Mar 27, 2023	Supplement 5Labeling · Standard review	Approved	None posted
Oct 29, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Oct 29, 2019	Supplement 4Labeling · Standard review	Approved	None posted
May 12, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 205241
Drugs@FDA: Overview at FDA
Company: Gland Pharma

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