Assyro AI

Orange Book product · Generic (ANDA)

VARENICLINE TARTRATE

VARENICLINE TARTRATE

Generic (ANDA)ANDA 218302TE ABRX MICRO LABS
View VARENICLINE TARTRATE familyOpen on FDA Orange Book

At a glance

Oct 29, 2025

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 29, 2025

    8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

VARENICLINE TARTRATE

Strength

EQ 0.5MG BASE

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 218302

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of VARENICLINE TARTRATE

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.

Book a Demo