Details for New Drug Application (NDA): 202068

NDA 202068 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 fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the methimazole profile page.

Summary for 202068

Tradename:	METHIMAZOLE
Applicant:	Rising
Ingredient:	methimazole
Patents:	0

Pharmacology for NDA: 202068

Mechanism of Action

Thyroid Hormone Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for 202068

Antithyroid Agents

Suppliers and Packaging for NDA: 202068

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHIMAZOLE	methimazole	TABLET;ORAL	202068	ANDA	Rising Pharmaceuticals, Inc.	64980-264	64980-264-01	100 TABLET in 1 BOTTLE (64980-264-01)
METHIMAZOLE	methimazole	TABLET;ORAL	202068	ANDA	Rising Pharmaceuticals, Inc.	64980-265	64980-265-01	100 TABLET in 1 BOTTLE (64980-265-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Mar 7, 2012	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Mar 7, 2012	TE:	AB	RLD:	No

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