Haloperidol

ANDA 91637, held by Sagent Pharms. Haloperidol Lactate.

As of Nov 14, 2026, ANDA 91637 (Haloperidol), held by Sagent Pharms, was first approved by FDA on Sep 2, 2011, with 7 approved supplements and 0 published complete response letters.

First approved: Sep 2, 2011
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Sep 2, 2011	Original application	Approved	None posted

Products

1 strengths and forms

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

All 8 submissions, including labeling and manufacturing supplements


Jan 22, 2025	Supplement 11Labeling · Standard review	Approved	None posted
Oct 29, 2024	Supplement 9Labeling · Standard review	Approved	None posted
Feb 21, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Jun 8, 2018	Supplement 3Labeling · Standard review	Approved	None posted
Jun 8, 2018	Supplement 4Labeling · Standard review	Approved	None posted
Jun 8, 2018	Supplement 5Labeling · Standard review	Approved	None posted
Jan 12, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Sep 2, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 91637
Drugs@FDA: Overview at FDA
Company: Sagent Pharmaceuticals

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