Antabuse

NDA 7883, held by Teva Womens. Disulfiram.

As of Nov 13, 2026, NDA 7883 (Antabuse), held by Teva Womens, was first approved by FDA on Aug 28, 1951, with 18 approved supplements and 0 published complete response letters.

First approved: Aug 28, 1951
Review: Priority
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Aug 28, 1951	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Antabuse500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Disulfiram	DiscontinuedReference drug
Antabuse250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Disulfiram	DiscontinuedReference drug

All 19 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 29, 2000	Supplement 30Labeling · Standard review	Approved	None posted
Feb 21, 1995	Supplement 29Labeling	Approved	None posted
Mar 27, 1989	Supplement 28Manufacturing · Priority review	Approved	None posted
Aug 14, 1987	Supplement 26Manufacturing · Priority review	Approved	None posted
Jul 28, 1986	Supplement 24Labeling	Approved	None posted
May 20, 1985	Supplement 23Manufacturing · Priority review	Approved	None posted
Apr 1, 1985	Supplement 20Manufacturing · Priority review	Approved	None posted
Oct 15, 1984	Supplement 22Manufacturing · Priority review	Approved	None posted
Jul 26, 1982	Supplement 19Manufacturing · Priority review	Approved	None posted
Jul 20, 1982	Supplement 15Manufacturing · Priority review	Approved	None posted
Feb 11, 1982	Supplement 16Manufacturing · Priority review	Approved	None posted
Mar 20, 1980	Supplement 13Labeling	Approved	None posted
Mar 20, 1980	Supplement 14Labeling	Approved	None posted
Feb 21, 1980	Supplement 10Manufacturing · Priority review	Approved	None posted
May 25, 1979	Supplement 12Manufacturing · Priority review	Approved	None posted
Dec 22, 1978	Supplement 9Labeling	Approved	None posted
Sep 26, 1978	Supplement 11Labeling	Approved	None posted
Jan 5, 1977	Supplement 8Labeling	Approved	None posted
Aug 28, 1951	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 7883
Drugs@FDA: Overview at FDA
Company: Teva Women's Health

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