Haloperidol Decanoate

ANDA 76463, held by Sandoz. Haloperidol Decanoate.

As of Nov 14, 2026, ANDA 76463 (Haloperidol Decanoate), held by Sandoz, was first approved by FDA on Jun 24, 2005, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 24, 2005
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jun 24, 2005	Original application	Approved	None posted

Products

2 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Aug 18, 2025	Supplement 3Labeling · Standard review	Approved	None posted
Jun 24, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 76463
Drugs@FDA: Overview at FDA
Company: Sandoz

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