Mintezol

NDA 16097, held by Merck Sharp Dohme. Thiabendazole.

As of Nov 13, 2026, NDA 16097 (Mintezol), held by Merck Sharp Dohme, was first approved by FDA on Apr 21, 1967, with 16 approved supplements and 0 published complete response letters.

First approved: Apr 21, 1967
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Apr 21, 1967	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mintezol500MG/5ML · suspension;oral	Thiabendazole	Discontinued

All 17 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 11, 2003	Supplement 26Labeling · Standard review	Approved	Letter Label
Oct 24, 2002	Supplement 25Manufacturing · Standard review	Approved	None posted
Jun 29, 2001	Supplement 24Labeling · Standard review	Approved	Letter
Jun 3, 1996	Supplement 23Labeling	Approved	None posted
Apr 4, 1990	Supplement 22Manufacturing · Standard review	Approved	None posted
Apr 6, 1987	Supplement 18Labeling	Approved	None posted
Oct 18, 1985	Supplement 21Labeling	Approved	None posted
Apr 1, 1985	Supplement 17Labeling	Approved	None posted
Jan 23, 1985	Supplement 20Manufacturing · Standard review	Approved	None posted
Nov 9, 1983	Supplement 15Labeling	Approved	None posted
Apr 17, 1978	Supplement 13Labeling	Approved	None posted
May 3, 1977	Supplement 12Labeling	Approved	None posted
Sep 9, 1976	Supplement 11Labeling	Approved	None posted
Jun 24, 1976	Supplement 10Manufacturing · Standard review	Approved	None posted
Oct 30, 1975	Supplement 9Labeling	Approved	None posted
Feb 21, 1975	Supplement 8Manufacturing · Standard review	Approved	None posted
Apr 21, 1967	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 16097
Drugs@FDA: Overview at FDA
Company: Merck Sharp & Dohme

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