Haloperidol Decanoate

Treats schizophrenia. ANDA 211180, held by Zydus Pharms. Haloperidol Decanoate.

As of Nov 14, 2026, ANDA 211180 (Haloperidol Decanoate), held by Zydus Pharms, was first approved by FDA on Oct 22, 2019, with 3 approved supplements and 0 published complete response letters.

First approved: Oct 22, 2019
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Haloperidol decanoate 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 4 submissions below

Date	Submission	Status	Documents
Oct 22, 2019	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 4 submissions, including labeling and manufacturing supplements


Sep 23, 2026	Supplement 8Labeling · Standard review	Approved	None posted
Jan 5, 2026	Supplement 5Labeling · Standard review	Approved	None posted
Mar 27, 2023	Supplement 3Labeling · Standard review	Approved	None posted
Oct 22, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 211180
Drugs@FDA: Overview at FDA
Company: Zydus Pharmaceuticals (USA)

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