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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018612

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NDA 018612 describes NICORETTE (MINT), which is a drug marketed by Glaxosmithkline and is included in two NDAs. It is available from four suppliers. Additional details are available on the NICORETTE (MINT) profile page.

The generic ingredient in NICORETTE (MINT) is nicotine polacrilex. There are thirty drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.
Summary for 018612
Tradename:NICORETTE (MINT)
Applicant:Glaxosmithkline
Ingredient:nicotine polacrilex
Patents:1
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 018612
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NICORETTE nicotine polacrilex GUM, CHEWING;BUCCAL 018612 NDA GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 0135-0157 N 0135-0157-07
NICORETTE nicotine polacrilex GUM, CHEWING;BUCCAL 018612 NDA GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 0135-0157 N 0135-0157-10

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:GUM, CHEWING;BUCCALStrengthEQ 2MG BASE
Approval Date:Feb 9, 1996TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Apr 30, 2028Product Flag?Substance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:OTCDosage:GUM, CHEWING;BUCCALStrengthEQ 2MG BASE
Approval Date:Dec 23, 1998TE:RLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:OTCDosage:GUM, CHEWING;BUCCALStrengthEQ 2MG BASE
Approval Date:Sep 25, 2000TE:RLD:Yes

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