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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 021928


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NDA 021928 describes CHANTIX, which is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from three suppliers. Additional details are available on the CHANTIX profile page.

The generic ingredient in CHANTIX is varenicline tartrate. There are twelve drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the varenicline tartrate profile page.
Summary for 021928
Tradename:CHANTIX
Applicant:Pf Prism Cv
Ingredient:varenicline tartrate
Patents:0
Pharmacology for NDA: 021928
Mechanism of ActionCholinergic Agonists
Partial Cholinergic Nicotinic Agonists
Medical Subject Heading (MeSH) Categories for 021928
Nicotinic Agonists
Suppliers and Packaging for NDA: 021928
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHANTIX varenicline tartrate TABLET;ORAL 021928 NDA Pfizer Laboratories Div Pfizer Inc 0069-0468 0069-0468-56 56 TABLET, FILM COATED in 1 BOTTLE (0069-0468-56)
CHANTIX varenicline tartrate TABLET;ORAL 021928 NDA Pfizer Laboratories Div Pfizer Inc 0069-0469 0069-0469-28 56 TABLET, FILM COATED in 1 BLISTER PACK (0069-0469-28)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:May 10, 2006TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:May 10, 2006TE:ABRLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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