Assyro AI

Orange Book product · Generic (ANDA)

HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE

Generic (ANDA)ANDA 040907TE ABRX UNICHEM

At a glance

Apr 03, 2025

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 03, 2025

    1 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HYDROCHLOROTHIAZIDE

Strength

12.5MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 040907

Product number

003

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of HYDROCHLOROTHIAZIDE

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.