Details for New Drug Application (NDA): 021928

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. Twenty-seven 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 Action

Cholinergic 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	0069-0469-03	1 BLISTER PACK in 1 CARTON (0069-0469-03) / 56 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	May 10, 2006	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	May 10, 2006	TE:		RLD:	Yes

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