Orange Book product · Brand (NDA)

CHANTIX

VARENICLINE TARTRATE

Brand (NDA)NDA 021928TE ABRX PF PRISM CV

View VARENICLINE TARTRATE family Open on FDA Orange Book

At a glance

May 10, 2006

Approved

Brand (NDA)

Application

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
May 10, 2006
20 yr 5 mo ago
Today

Pharmaceutical detail

Active ingredient

VARENICLINE TARTRATE

Strength

EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 021928

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

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.

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