Last Updated: August 9, 2026

Details for New Drug Application (NDA): 040350


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NDA 040350 describes METHIMAZOLE, which is a drug marketed by Aiping Pharm Inc, Bionpharma, Chartwell Rx, Discovery Therap, Heritage Pharma, Macleods Pharms Ltd, Mylan, Rising, Square Pharms Plc, and Sun Pharm Inds Inc, and is included in ten NDAs. It is available from twenty-one suppliers. Additional details are available on the METHIMAZOLE profile page.

The generic ingredient in METHIMAZOLE is methimazole. There are three drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the methimazole profile page.
Summary for 040350
Tradename:METHIMAZOLE
Applicant:Mylan
Ingredient:methimazole
Patents:0
Pharmacology for NDA: 040350
Mechanism of ActionThyroid Hormone Synthesis Inhibitors
Medical Subject Heading (MeSH) Categories for 040350
Antithyroid Agents
Suppliers and Packaging for NDA: 040350
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHIMAZOLE methimazole TABLET;ORAL 040350 ANDA American Health Packaging 60687-669 60687-669-01 100 BLISTER PACK in 1 CARTON (60687-669-01) / 1 TABLET in 1 BLISTER PACK (60687-669-11)
METHIMAZOLE methimazole TABLET;ORAL 040350 ANDA American Health Packaging 60687-680 60687-680-01 100 BLISTER PACK in 1 CARTON (60687-680-01) / 1 TABLET in 1 BLISTER PACK (60687-680-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Mar 29, 2000TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Mar 29, 2000TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG
Approval Date:Jun 7, 2001TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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