Haloperidol Decanoate

ANDA 74811, held by Hikma. Haloperidol Decanoate.

As of Nov 14, 2026, ANDA 74811 (Haloperidol Decanoate), held by Hikma, was first approved by FDA on Jan 30, 1998, with 8 approved supplements and 0 published complete response letters.

First approved: Jan 30, 1998
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jan 30, 1998	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Haloperidol DecanoateEQ 50MG BASE/ML · injectable;injection	Haloperidol Decanoate	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Sep 27, 2011	Supplement 17Labeling	Approved	None posted
Sep 27, 2011	Supplement 15Labeling	Approved	None posted
Jan 7, 2010	Supplement 13Labeling	Approved	None posted
Nov 19, 2008	Supplement 12Labeling	Approved	None posted
Jun 18, 2008	Supplement 11Labeling	Approved	None posted
Feb 4, 2008	Supplement 10Labeling	Approved	None posted
Oct 16, 2001	Supplement 1Labeling	Approved	None posted
Apr 3, 2001	Supplement 2Manufacturing	Approved	None posted
Jan 30, 1998	Original application	Approved	Review

Identifiers

Application: ANDA 74811
Drugs@FDA: Overview at FDA
Company: Hikma

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