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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 020386

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NDA 020386 describes COZAAR, 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 COZAAR profile page.

The generic ingredient in COZAAR is losartan potassium. There are thirty-nine drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the losartan potassium profile page.

Summary for 020386

Tradename:	COZAAR
Applicant:	Organon
Ingredient:	losartan potassium
Patents:	0

Pharmacology for NDA: 020386

Mechanism of Action	Angiotensin 2 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 020386

Angiotensin II Type 1 Receptor Blockers
Anti-Arrhythmia Agents
Antihypertensive Agents

Suppliers and Packaging for NDA: 020386

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COZAAR	losartan potassium	TABLET;ORAL	020386	NDA	Organon LLC	78206-121	78206-121-01	90 TABLET, FILM COATED in 1 BOTTLE (78206-121-01)
COZAAR	losartan potassium	TABLET;ORAL	020386	NDA	Organon LLC	78206-122	78206-122-01	30 TABLET, FILM COATED in 1 BOTTLE (78206-122-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Apr 14, 1995	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Apr 14, 1995	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Oct 13, 1998	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020386

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-002	Apr 14, 1995	5,608,075*PED	⤷ Get Started Free
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-003	Oct 13, 1998	5,608,075	⤷ Get Started Free
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-001	Apr 14, 1995	5,608,075*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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