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Generated: June 17, 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. Eighteen 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
Medical Subject Heading (MeSH) Categories for 040320
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:RXDosage:TABLET;ORALStrength5MG
Approval Date:Mar 31, 2000TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Mar 31, 2000TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
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QuintilesIMS
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