Assyro AI

Orange Book product · Brand (NDA)

AVALIDE

HYDROCHLOROTHIAZIDE; IRBESARTAN

Brand (NDA)NDA 020758DISCN SANOFI AVENTIS US
View HYDROCHLOROTHIAZIDE; IRBESARTAN familyOpen on FDA Orange Book

At a glance

Sep 30, 1997

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 30, 1997

    29 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HYDROCHLOROTHIAZIDE; IRBESARTAN

Strength

12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 020758

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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.

Agent CTA Background

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