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Orange Book product · Generic (ANDA)

IRBESARTAN AND HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE; IRBESARTAN

Generic (ANDA)ANDA 203036DISCN ATLAS PHARMS LLC
View HYDROCHLOROTHIAZIDE; IRBESARTAN familyOpen on FDA Orange Book

At a glance

Jan 15, 2016

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 15, 2016

    10 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HYDROCHLOROTHIAZIDE; IRBESARTAN

Strength

12.5MG;150MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 203036

Product number

001

Marketing status

DISCN

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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