Orange Book product · Brand (NDA)

HYZAAR

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Brand (NDA)NDA 020387TE ABRX ORGANON

View HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM family Open on FDA Orange Book

At a glance

Apr 28, 1995

Approved

Brand (NDA)

Application

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Apr 28, 1995
31 yr 7 mo ago
Today

Pharmaceutical detail

Active ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Strength

12.5MG;50MG

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 020387

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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