Details for New Drug Application (NDA): 040547

NDA 040547 describes METHIMAZOLE, which is a drug marketed by Bionpharma, Chartwell Rx, Discovery Therap, Heritage Pharma, Macleods Pharms Ltd, Mylan, Qingdao Baheal Pharm, Rising, and Sun Pharm Inds Inc, and is included in nine NDAs. It is available from fifteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the methimazole profile page.

Summary for 040547

Tradename:	METHIMAZOLE
Applicant:	Qingdao Baheal Pharm
Ingredient:	methimazole
Patents:	0

Pharmacology for NDA: 040547

Mechanism of Action

Thyroid 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:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Feb 18, 2005	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Feb 18, 2005	TE:	AB	RLD:	No

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Feb 18, 2005	TE:		RLD:	No

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