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Orange Book product · Generic (ANDA)

GUANFACINE HYDROCHLORIDE

GUANFACINE HYDROCHLORIDE

Generic (ANDA)ANDA 205689DISCN SUN PHARM

At a glance

Nov 16, 2017

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 16, 2017

    8 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

GUANFACINE HYDROCHLORIDE

Strength

EQ 1MG BASE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

ANDA 205689

Product number

001

Marketing status

DISCN

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

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