Tapazole

ANDA 40320, held by King Pharms LLC. Methimazole.

As of Nov 13, 2026, ANDA 40320 (Tapazole), held by King Pharms LLC, was first approved by FDA on Mar 31, 2000, with 6 approved supplements and 0 published complete response letters.

First approved: Mar 31, 2000
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Mar 31, 2000	Original application	Approved	Letter

Products

2 strengths and forms


Tapazole5MG · tablet;oral	Methimazole	Discontinued
Tapazole10MG · tablet;oral	Methimazole	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Jun 14, 2024	Supplement 13Labeling · Standard review	Approved	None posted
Jan 18, 2019	Supplement 12Labeling · Standard review	Approved	None posted
Jan 4, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Jan 15, 2016	Supplement 11Labeling · Standard review	Approved	None posted
Jul 16, 2012	Supplement 5Labeling	Approved	Label
Aug 6, 2004	Supplement 1Labeling	Approved	None posted
Mar 31, 2000	Original application	Approved	Letter

Identifiers

Application: ANDA 40320
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