Haloperidol

ANDA 210356, held by Fresenius Kabi USA. Haloperidol Lactate.

As of Nov 15, 2026, ANDA 210356 (Haloperidol), held by Fresenius Kabi USA, was first approved by FDA on Jul 1, 2019, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 1, 2019
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jul 1, 2019	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
HaloperidolEQ 5MG BASE/ML · injectable;injection	Haloperidol Lactate	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jan 22, 2025	Supplement 3Labeling · Standard review	Approved	None posted
Jun 27, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Jul 1, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 210356
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi 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