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NICORETTE

NDA · New Drug Application · Sponsor: HALEON US HOLDINGS · Approved 1984-01-13

Drug application

FDA Application #

NDA018612

Application type

New Drug Application

Brand name

NICORETTE

Generic name

NICOTINE POLACRILEX

Active ingredients

NICOTINE POLACRILEX

Dosage form

GUM, CHEWING

Route

BUCCAL

Marketing status

Over-the-counter

Sponsor

HALEON US HOLDINGS

Manufacturer

Haleon US Holdings LLC

First approval

1984-01-13

Source

Authoritative

Drugs@FDA application overview

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