Haloperidol

ANDA 76464, held by Fosun Pharma. Haloperidol Lactate.

As of Nov 15, 2026, ANDA 76464 (Haloperidol), held by Fosun Pharma, was first approved by FDA on Sep 29, 2004, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 29, 2004
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
Sep 29, 2004	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 4Labeling · Standard review	Approved	None posted
Jul 31, 2013	Supplement 2Labeling	Approved	None posted
Sep 29, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 76464
Drugs@FDA: Overview at FDA
Company: Fosun 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