Antizol

NDA 20696, held by Par Pharm Inc. Fomepizole.

As of Nov 13, 2026, NDA 20696 (Antizol), held by Par Pharm Inc, was first approved by FDA on Dec 4, 1997, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 4, 1997
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Dec 8, 2000	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter
Dec 4, 1997	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Antizol1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Fomepizole	DiscontinuedReference drug

All 4 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 23, 2020	Supplement 6Labeling · Standard review	Approved	Label Letter
Dec 13, 2013	Supplement 5Manufacturing · Standard review	Approved	None posted
Dec 8, 2000	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter
Dec 4, 1997	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 20696
Drugs@FDA: Overview at FDA
Company: Par 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