Haloperidol Decanoate

Treats schizophrenia. ANDA 216730, held by Mankind Pharma. Haloperidol Decanoate.

As of Nov 14, 2026, ANDA 216730 (Haloperidol Decanoate), held by Mankind Pharma, was first approved by FDA on May 23, 2023, with 2 approved supplements and 0 published complete response letters.

First approved: May 23, 2023
Review: Standard
Supplements approved: 2
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 3 submissions below

Date	Submission	Status	Documents
May 23, 2023	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 3 submissions, including labeling and manufacturing supplements


Mar 27, 2026	Supplement 8Labeling · Standard review	Approved	None posted
Jul 24, 2025	Supplement 4Labeling · Standard review	Approved	None posted
May 23, 2023	Original application	Approved	None posted

Identifiers

Application: ANDA 216730
Drugs@FDA: Overview at FDA
Company: Mankind 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