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Orange Book product · Generic (ANDA)

IRBESARTAN AND HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE; IRBESARTAN

Generic (ANDA)ANDA 202414TE ABRX MACLEODS PHARMS LTD
View HYDROCHLOROTHIAZIDE; IRBESARTAN familyOpen on FDA Orange Book

At a glance

Sep 27, 2012

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 27, 2012

    13 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HYDROCHLOROTHIAZIDE; IRBESARTAN

Strength

12.5MG;150MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 202414

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of HYDROCHLOROTHIAZIDE; IRBESARTAN

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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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