Haloperidol Decanoate

ANDA 74893, held by Fresenius Kabi USA. Haloperidol Decanoate.

First approved: Dec 19, 1997
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Dec 19, 1997	Original application	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Haloperidol DecanoateEQ 50MG BASE/ML · injectable;injection	Haloperidol Decanoate	Rx
Haloperidol DecanoateEQ 100MG BASE/ML · injectable;injection	Haloperidol Decanoate	Rx

All 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 1, 2025	Supplement 29Labeling · Standard review	Approved	None posted
Jun 20, 2025	Supplement 22Labeling · Standard review	Approved	None posted
Jun 20, 2025	Supplement 23Labeling · Standard review	Approved	None posted
Jun 20, 2025	Supplement 24Labeling · Standard review	Approved	None posted
Jun 30, 2016	Supplement 19Labeling · Standard review	Approved	None posted
May 22, 2012	Supplement 17Labeling	Approved	None posted
Sep 27, 2011	Supplement 16Labeling	Approved	None posted
Mar 14, 2009	Supplement 13Labeling	Approved	None posted
Oct 30, 2008	Supplement 12Labeling	Approved	None posted
Dec 5, 2002	Supplement 4Manufacturing	Approved	None posted
Nov 19, 1999	Supplement 2Manufacturing	Approved	None posted
Jan 21, 1999	Supplement 1Manufacturing	Approved	None posted
Dec 19, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74893
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters