Last Updated: June 18, 2026

Details for New Drug Application (NDA): 040547


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NDA 040547 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 040547
Tradename:METHIMAZOLE
Applicant:Aiping Pharm Inc
Ingredient:methimazole
Patents:0
Pharmacology for NDA: 040547
Mechanism of ActionThyroid Hormone Synthesis Inhibitors
Medical Subject Heading (MeSH) Categories for 040547
Antithyroid Agents
Suppliers and Packaging for NDA: 040547
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHIMAZOLE methimazole TABLET;ORAL 040547 ANDA Upsher-Smith Laboratories, LLC 0832-6072 0832-6072-11 100 TABLET in 1 BOTTLE (0832-6072-11)
METHIMAZOLE methimazole TABLET;ORAL 040547 ANDA Upsher-Smith Laboratories, LLC 0832-6073 0832-6073-11 100 TABLET in 1 BOTTLE (0832-6073-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Feb 18, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Feb 18, 2005TE:ABRLD:No

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG
Approval Date:Feb 18, 2005TE:RLD:No

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Preferred Citation:

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