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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Fish and Richardson
Julphar
Cipla
Baxter
Chinese Patent Office
Moodys
Daiichi Sankyo
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Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020387

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NDA 020387 describes HYZAAR, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from seven suppliers. Additional details are available on the HYZAAR profile page.

The generic ingredient in HYZAAR is hydrochlorothiazide; losartan potassium. There are thirty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; losartan potassium profile page.
Summary for 020387
Tradename:HYZAAR
Applicant:Merck Sharp Dohme
Ingredient:hydrochlorothiazide; losartan potassium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020387
Ingredient-typeThiazides
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 020387
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYZAAR hydrochlorothiazide; losartan potassium TABLET;ORAL 020387 NDA Merck Sharp & Dohme Corp. 0006-0717 N 0006-0717-31
HYZAAR hydrochlorothiazide; losartan potassium TABLET;ORAL 020387 NDA Merck Sharp & Dohme Corp. 0006-0717 N 0006-0717-54

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength12.5MG;50MG
Approval Date:Apr 28, 1995TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG;100MG
Approval Date:Nov 10, 1998TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;100MG
Approval Date:Oct 20, 2005TE:ABRLD:Yes

Expired US Patents for NDA 020387

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme HYZAAR hydrochlorothiazide; losartan potassium TABLET;ORAL 020387-002 Nov 10, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme HYZAAR hydrochlorothiazide; losartan potassium TABLET;ORAL 020387-001 Apr 28, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme HYZAAR hydrochlorothiazide; losartan potassium TABLET;ORAL 020387-001 Apr 28, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme HYZAAR hydrochlorothiazide; losartan potassium TABLET;ORAL 020387-003 Oct 20, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Medtronic
Fish and Richardson
McKesson
Merck
Farmers Insurance
Chubb
QuintilesIMS
Johnson and Johnson

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