Assyro AI

Orange Book product · Brand (NDA)

BENICAR HCT

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Brand (NDA)NDA 021532TE ABRX COSETTE
View HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL familyOpen on FDA Orange Book

At a glance

Jun 05, 2003

Approved

Brand (NDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 05, 2003

    23 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Strength

12.5MG;20MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

NDA 021532

Product number

002

Marketing status

RX

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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