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Orange Book product · Generic (ANDA)

GUANFACINE HYDROCHLORIDE

GUANFACINE HYDROCHLORIDE

Generic (ANDA)ANDA 219689TE ABRX RUBICON RESEARCH
View GUANFACINE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Apr 15, 2025

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 15, 2025

    1 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

GUANFACINE HYDROCHLORIDE

Strength

EQ 1MG BASE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

AB

Application

ANDA 219689

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of GUANFACINE HYDROCHLORIDE

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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