Details for New Drug Application (NDA): 020387

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NDA 020387 describes HYZAAR, which is a drug marketed by Organon and is included in one NDA. It is available from one supplier. 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. Thirty-one suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; losartan potassium profile page.

Summary for 020387

Tradename:	HYZAAR
Applicant:	Organon
Ingredient:	hydrochlorothiazide; losartan potassium
Patents:	0

Pharmacology for NDA: 020387

Mechanism of Action	Angiotensin 2 Receptor Antagonists
Physiological Effect	Increased 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	Organon LLC	78206-139	78206-139-01	30 TABLET, FILM COATED in 1 BOTTLE (78206-139-01)
HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387	NDA	Organon LLC	78206-139	78206-139-02	90 TABLET, FILM COATED in 1 BOTTLE (78206-139-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG;50MG
Approval Date:	Apr 28, 1995	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG;100MG
Approval Date:	Nov 10, 1998	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG;100MG
Approval Date:	Oct 20, 2005	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020387

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-001	Apr 28, 1995	⤷ Sign Up	⤷ Sign Up
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-001	Apr 28, 1995	⤷ Sign Up	⤷ Sign Up
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-003	Oct 20, 2005	⤷ Sign Up	⤷ Sign Up
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-002	Nov 10, 1998	⤷ Sign Up	⤷ Sign Up
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-002	Nov 10, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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