Haldol

NDA 15922, held by Ortho Mcneil. Haloperidol Lactate.

As of Nov 13, 2026, NDA 15922 (Haldol), held by Ortho Mcneil, was first approved by FDA on Apr 12, 1967, with 32 approved supplements and 0 published complete response letters.

First approved: Apr 12, 1967
Review: Priority
Supplements approved: 32
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 33 submissions below

Date	Submission	Status	Documents
Apr 12, 1967	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
HaldolEQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · concentrate;oral	Haloperidol Lactate	DiscontinuedReference drug

All 33 submissions, including labeling and manufacturing supplements


Apr 17, 2002	Supplement 66Labeling · Priority review	Approved	None posted
May 2, 2000	Supplement 65Labeling · Priority review	Approved	None posted
Apr 23, 1998	Supplement 61Manufacturing · Priority review	Approved	None posted
May 10, 1996	Supplement 62Manufacturing · Priority review	Approved	None posted
Jan 30, 1995	Supplement 59Manufacturing · Priority review	Approved	None posted
Jun 29, 1994	Supplement 58Manufacturing · Priority review	Approved	None posted
Jul 7, 1989	Supplement 56Manufacturing · Priority review	Approved	None posted
Jul 14, 1988	Supplement 52Manufacturing · Priority review	Approved	None posted
Apr 13, 1988	Supplement 53Manufacturing · Priority review	Approved	None posted
Jan 8, 1987	Supplement 40Manufacturing · Priority review	Approved	None posted
Oct 22, 1986	Supplement 43Manufacturing · Priority review	Approved	None posted
Oct 22, 1986	Supplement 42Manufacturing · Priority review	Approved	None posted
Jan 14, 1986	Supplement 37Manufacturing · Priority review	Approved	None posted
Jan 14, 1986	Supplement 36Manufacturing · Priority review	Approved	None posted
Jan 14, 1986	Supplement 35Manufacturing · Priority review	Approved	None posted
Jan 14, 1986	Supplement 33Manufacturing · Priority review	Approved	None posted
Mar 11, 1983	Supplement 28Labeling · Priority review	Approved	None posted
Jan 31, 1983	Supplement 27Labeling · Priority review	Approved	None posted
Sep 8, 1982	Supplement 26Labeling · Priority review	Approved	None posted
Jun 23, 1982	Supplement 24Manufacturing · Priority review	Approved	None posted
Apr 20, 1982	Supplement 25Manufacturing · Priority review	Approved	None posted
Oct 2, 1981	Supplement 23Labeling · Priority review	Approved	None posted
Jan 23, 1981	Supplement 21Labeling · Priority review	Approved	None posted
Jan 23, 1981	Supplement 20Labeling · Priority review	Approved	None posted
Jul 28, 1980	Supplement 18Manufacturing · Priority review	Approved	None posted
May 19, 1980	Supplement 19Manufacturing · Priority review	Approved	None posted
Feb 12, 1980	Supplement 14Labeling · Priority review	Approved	None posted
Jan 15, 1980	Supplement 16Manufacturing · Priority review	Approved	None posted
Jul 6, 1979	Supplement 17Labeling · Priority review	Approved	None posted
Jul 6, 1979	Supplement 15Labeling · Priority review	Approved	None posted
Apr 12, 1979	Supplement 13Manufacturing · Priority review	Approved	None posted
Feb 13, 1978	Supplement 12Labeling · Priority review	Approved	None posted
Apr 12, 1967	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 15922
Drugs@FDA: Overview at FDA
Company: Ortho-McNeil Pharmaceutical

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