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Generated: November 15, 2018

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Details for New Drug Application (NDA): 020066

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NDA 020066 describes NICORETTE (MINT), which is a drug marketed by Glaxosmithkline and is included in two NDAs. It is available from two 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-six suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.
Summary for 020066
Tradename:NICORETTE (MINT)
Applicant:Glaxosmithkline
Ingredient:nicotine polacrilex
Patents:1
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020066
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NICORETTE nicotine polacrilex GUM, CHEWING;BUCCAL 020066 NDA GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 0135-0158 0135-0158-07 1 BLISTER PACK in 1 CARTON (0135-0158-07) > 110 GUM, CHEWING in 1 BLISTER PACK
NICORETTE nicotine polacrilex GUM, CHEWING;BUCCAL 020066 NDA GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 0135-0158 0135-0158-10 1 BLISTER PACK in 1 CARTON (0135-0158-10) > 170 GUM, CHEWING in 1 BLISTER PACK

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:GUM, CHEWING;BUCCALStrengthEQ 4MG BASE
Approval Date:Feb 9, 1996TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Apr 30, 2028Product Flag?YSubstance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:OTCDosage:GUM, CHEWING;BUCCALStrengthEQ 4MG BASE
Approval Date:Dec 23, 1998TE:RLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:OTCDosage:GUM, CHEWING;BUCCALStrengthEQ 4MG BASE
Approval Date:Sep 25, 2000TE:RLD:Yes

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