Haldol

NDA 15921, held by Ortho Mcneil. Haloperidol.

As of Nov 14, 2026, NDA 15921 (Haldol), held by Ortho Mcneil, was first approved by FDA on Apr 12, 1967, with 35 approved supplements and 0 published complete response letters.

First approved: Apr 12, 1967
Review: Priority
Supplements approved: 35
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 36 submissions below

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

Products

6 strengths and forms


Haldol0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Haloperidol	DiscontinuedReference drug
Haldol1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Haloperidol	DiscontinuedReference drug
Haldol2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Haloperidol	DiscontinuedReference drug
Haldol5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Haloperidol	DiscontinuedReference drug
Haldol10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Haloperidol	DiscontinuedReference drug
Haldol20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Haloperidol	DiscontinuedReference drug

All 36 submissions, including labeling and manufacturing supplements


Apr 17, 2002	Supplement 76Labeling · Priority review	Approved	None posted
May 2, 2000	Supplement 75Labeling · Priority review	Approved	None posted
Apr 23, 1998	Supplement 71Manufacturing · Priority review	Approved	None posted
May 10, 1996	Supplement 72Manufacturing · Priority review	Approved	None posted
Jan 30, 1995	Supplement 68Manufacturing · Priority review	Approved	None posted
Jun 29, 1994	Supplement 67Manufacturing · Priority review	Approved	None posted
Apr 6, 1990	Supplement 65Manufacturing · Priority review	Approved	None posted
Oct 4, 1988	Supplement 62Manufacturing · Priority review	Approved	None posted
Feb 17, 1988	Supplement 61Manufacturing · Priority review	Approved	None posted
Oct 16, 1987	Supplement 59Manufacturing · Priority review	Approved	None posted
Oct 22, 1986	Supplement 53Manufacturing · Priority review	Approved	None posted
Feb 6, 1986	Supplement 48Manufacturing · Priority review	Approved	None posted
Apr 30, 1985	Supplement 47Manufacturing · Priority review	Approved	None posted
Apr 30, 1985	Supplement 46Manufacturing · Priority review	Approved	None posted
Mar 18, 1983	Supplement 40Manufacturing · Priority review	Approved	None posted
Mar 18, 1983	Supplement 39Manufacturing · Priority review	Approved	None posted
Mar 18, 1983	Supplement 38Manufacturing · Priority review	Approved	None posted
Mar 11, 1983	Supplement 37Labeling · Priority review	Approved	None posted
Jan 31, 1983	Supplement 36Labeling · Priority review	Approved	None posted
Sep 8, 1982	Supplement 35Labeling · Priority review	Approved	None posted
Sep 3, 1982	Supplement 34Manufacturing · Priority review	Approved	None posted
Jun 23, 1982	Supplement 32Manufacturing · Priority review	Approved	None posted
Apr 20, 1982	Supplement 33Manufacturing · Priority review	Approved	None posted
Feb 2, 1982	Supplement 26Manufacturing · Priority review	Approved	None posted
Oct 2, 1981	Supplement 31Labeling · Priority review	Approved	None posted
Jan 23, 1981	Supplement 29Labeling · Priority review	Approved	None posted
Jan 23, 1981	Supplement 28Labeling · Priority review	Approved	None posted
Mar 7, 1980	Supplement 27Manufacturing · Priority review	Approved	None posted
Feb 12, 1980	Supplement 24Labeling · Priority review	Approved	None posted
Jul 6, 1979	Supplement 25Labeling · Priority review	Approved	None posted
Feb 13, 1978	Supplement 21Labeling · Priority review	Approved	None posted
Dec 12, 1977	Supplement 23Manufacturing · Priority review	Approved	None posted
Mar 26, 1976	Supplement 20Manufacturing · Priority review	Approved	None posted
Dec 10, 1974	Supplement 19Manufacturing · Priority review	Approved	None posted
May 21, 1974	Supplement 12REMS · Priority review	Approved	None posted
Apr 12, 1967	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 15921
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