varenicline

FDA Drug Profile — Tyrvaya, varenicline

Drug Details

Generic Name
varenicline
Brand Names
Tyrvaya, varenicline
Application Number
NDA213978
Sponsor
Oyster Point Pharma, Inc.
NDC Codes
4
Dosage Forms
SPRAY, TABLET, FILM COATED, KIT
Routes
NASAL, ORAL
Active Ingredients
VARENICLINE TARTRATE

Indications and Usage

1 INDICATIONS AND USAGE Varenicline tablets are indicated for use as an aid to smoking cessation treatment. Varenicline is a nicotinic receptor partial agonist indicated for use as an aid to smoking cessation treatment. (1 and 2.1)