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Generated: September 23, 2017

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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-one drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; losartan potassium profile page.

Summary for NDA: 020387

Tradename:
1
Applicant:
1
Ingredient:
1
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 0006-0717-31 30 TABLET, FILM COATED in 1 BOTTLE (0006-0717-31)
HYZAAR
hydrochlorothiazide; losartan potassium
TABLET;ORAL 020387 NDA Merck Sharp & Dohme Corp. 0006-0717 0006-0717-54 90 TABLET, FILM COATED in 1 BOTTLE (0006-0717-54)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

Expired Orange Book Patents for NDA: 020387



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Serving 500+ biopharmaceutical companies globally:

Colorcon
Healthtrust
Daiichi Sankyo
QuintilesIMS
Farmers Insurance
UBS
Novartis
Johnson and Johnson
McKesson
Julphar

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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