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Last Updated: November 18, 2019

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Details for New Drug Application (NDA): 021330

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NDA 021330 describes NICORETTE, which is a drug marketed by Glaxosmithkline and Glaxosmithkline Cons and is included in four NDAs. It is available from four 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-one suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.
Summary for 021330
Tradename:NICORETTE
Applicant:Glaxosmithkline Cons
Ingredient:nicotine polacrilex
Patents:0
Formulation / Manufacturing:see details
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 GlaxoSmithKline Consumer Healthcare Holdings (US) 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 GlaxoSmithKline Consumer Healthcare Holdings (US) 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:OTCDosage:TROCHE/LOZENGE;ORALStrengthEQ 2MG BASE
Approval Date:Oct 31, 2002TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TROCHE/LOZENGE;ORALStrengthEQ 4MG BASE
Approval Date:Oct 31, 2002TE:RLD:Yes

Expired US Patents for NDA 021330

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 021330-001 Oct 31, 2002   Start Trial   Start Trial
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 021330-002 Oct 31, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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