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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040320

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NDA 040320 describes TAPAZOLE, which is a drug marketed by King Pharms and King Pharms Llc and is included in two NDAs. It is available from one supplier. Additional details are available on the TAPAZOLE profile page.

The generic ingredient in TAPAZOLE 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 040320

Tradename:	TAPAZOLE
Applicant:	King Pharms Llc
Ingredient:	methimazole
Patents:	0
Therapeutic Class:	Hormonal Agents, Suppressant (Thyroid)
Formulation / Manufacturing:	see details

Pharmacology for NDA: 040320

Mechanism of Action	Thyroid Hormone Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for 040320

Antithyroid Agents

Suppliers and Packaging for NDA: 040320

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TAPAZOLE	methimazole	TABLET;ORAL	040320	ANDA	Pfizer Laboratories Div Pfizer Inc	60793-104	N	60793-104-01
TAPAZOLE	methimazole	TABLET;ORAL	040320	ANDA	Pfizer Laboratories Div Pfizer Inc	60793-105	N	60793-105-01

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Mar 31, 2000	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Mar 31, 2000	TE:	AB	RLD:	No

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