Methimazole

ANDA 40870, held by Sun Pharm Inds Inc. Methimazole.

As of Nov 13, 2026, ANDA 40870 (Methimazole), held by Sun Pharm Inds Inc, was first approved by FDA on Sep 25, 2007, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 25, 2007
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Sep 25, 2007	Original application	Approved	None posted

Products

2 strengths and forms


Methimazole5MG · tablet;oral	Methimazole	Discontinued
Methimazole10MG · tablet;oral	Methimazole	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jan 18, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Jan 15, 2016	Supplement 7Labeling · Standard review	Approved	None posted
Sep 25, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 40870
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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