Details for New Drug Application (NDA): 218830

NDA 218830 describes METHIMAZOLE, which is a drug marketed by Bionpharma, Chartwell Rx, Discovery Therap, Heritage Pharma, Macleods Pharms Ltd, Mylan, Qingdao Baheal Pharm, Rising, Square Pharms Plc, and Sun Pharm Inds Inc, and is included in ten NDAs. It is available from sixteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the methimazole profile page.

Summary for 218830

Tradename:	METHIMAZOLE
Applicant:	Square Pharms Plc
Ingredient:	methimazole
Patents:	0

Pharmacology for NDA: 218830

Mechanism of Action

Thyroid Hormone Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for 218830

Antithyroid Agents

Suppliers and Packaging for NDA: 218830

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHIMAZOLE	methimazole	TABLET;ORAL	218830	ANDA	SQUARE PHARMACEUTICALS PLC.	76483-082	76483-082-00	100 TABLET in 1 BOTTLE (76483-082-00)
METHIMAZOLE	methimazole	TABLET;ORAL	218830	ANDA	SQUARE PHARMACEUTICALS PLC.	76483-083	76483-083-00	100 TABLET in 1 BOTTLE (76483-083-00)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Feb 5, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Feb 5, 2025	TE:	AB	RLD:	No

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