Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021928

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CHANTIX (VARENICLINE TARTRATE)
EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: VARENICLINE TARTRATE
Proprietary Name: CHANTIX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021928
Product Number: 001
Approval Date: May 10, 2006
Applicant Holder Full Name: PF PRISM CV
Marketing Status:  Discontinued
Patent and Exclusivity Information

CHANTIX (VARENICLINE TARTRATE)
EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: VARENICLINE TARTRATE
Proprietary Name: CHANTIX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021928
Product Number: 002
Approval Date: May 10, 2006
Applicant Holder Full Name: PF PRISM CV
Marketing Status:  Discontinued
Patent and Exclusivity Information