Tapazole

NDA 7517, held by King Pharms. Methimazole.

As of Nov 13, 2026, NDA 7517 (Tapazole), held by King Pharms, was first approved by FDA on Jun 21, 1950, with 17 approved supplements and 0 published complete response letters.

First approved: Jun 21, 1950
Review: Priority
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Jun 21, 1950	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms


Tapazole5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Methimazole	DiscontinuedReference drug
Tapazole10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Methimazole	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements


Dec 7, 2007	Supplement 5Labeling	Approved	None posted
Dec 7, 2007	Supplement 6Labeling	Approved	None posted
Dec 7, 2007	Supplement 10Labeling	Approved	None posted
Dec 7, 2007	Supplement 11Labeling	Approved	None posted
Dec 7, 2007	Supplement 14Labeling	Approved	None posted
Jan 16, 2001	Supplement 22Labeling · Standard review	Approved	Label
Nov 17, 1998	Supplement 21Manufacturing · Priority review	Approved	None posted
Apr 2, 1998	Supplement 19Manufacturing · Priority review	Approved	None posted
Mar 25, 1998	Supplement 20Manufacturing · Priority review	Approved	None posted
Mar 20, 1995	Supplement 18Labeling · Standard review	Approved	None posted
Aug 7, 1992	Supplement 17Labeling	Approved	None posted
Oct 1, 1991	Supplement 15Manufacturing · Priority review	Approved	None posted
Jun 20, 1991	Supplement 16Labeling	Approved	None posted
Nov 13, 1990	Supplement 12Labeling	Approved	None posted
Feb 27, 1990	Supplement 13Labeling	Approved	None posted
Sep 24, 1985	Supplement 9Labeling	Approved	None posted
Feb 25, 1983	Supplement 8Labeling	Approved	None posted
Jun 21, 1950	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 7517
Drugs@FDA: Overview at FDA
Company: King Pharmaceuticals

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