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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 021330

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NDA 021330 describes NICORETTE, which is a drug marketed by Haleon Us Holdings and is included in four NDAs. It is available from two suppliers. There are three patents protecting this drug and two Paragraph IV challenges. Additional details are available on the NICORETTE profile page.

The generic ingredient in NICORETTE is nicotine polacrilex. There are thirty drug master file entries for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.

Summary for 021330

Tradename:	NICORETTE
Applicant:	Haleon Us Holdings
Ingredient:	nicotine polacrilex
Patents:	0

Pharmacology for NDA: 021330

Suppliers and Packaging for NDA: 021330

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	021330	NDA	Haleon US Holdings LLC	0135-0510	0135-0510-01	3 CONTAINER in 1 CARTON (0135-0510-01) / 24 LOZENGE in 1 CONTAINER
NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	021330	NDA	Haleon US Holdings LLC	0135-0510	0135-0510-06	1 CONTAINER in 1 CARTON (0135-0510-06) / 24 LOZENGE in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TROCHE/LOZENGE;ORAL			Strength	EQ 2MG BASE
Approval Date:	Oct 31, 2002	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TROCHE/LOZENGE;ORAL			Strength	EQ 4MG BASE
Approval Date:	Oct 31, 2002	TE:		RLD:	Yes

Expired US Patents for NDA 021330

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	021330-001	Oct 31, 2002	⤷ Get Started Free	⤷ Get Started Free
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	021330-002	Oct 31, 2002	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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