Orange Book product · Brand (NDA)

NICORETTE

NICOTINE POLACRILEX

Brand (NDA)NDA 020066OTC HALEON US HOLDINGS

Feb 09, 1996

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 09, 1996
30 yr 10 mo ago
Today
Patent 8323683 expires
Listed drug product patent expiration.
Apr 30, 2028
in 1 yr 11 mo

Active ingredient

NICOTINE POLACRILEX

Strength

EQ 4MG BASE

Dosage form

GUM, CHEWING

Route

BUCCAL

TE code

Not listed

Application

NDA 020066

Product number

002

Marketing status

OTC

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8323683	Apr 30, 2028	in 1 yr 11 mo	Product