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Last Updated: June 24, 2024

Details for New Drug Application (NDA): 018612


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NDA 018612 describes NICORETTE (MINT), which is a drug marketed by Haleon Us Holdings 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. Sixty suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.
Summary for 018612
Tradename:NICORETTE (MINT)
Applicant:Haleon Us Holdings
Ingredient:nicotine polacrilex
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 018612
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 Haleon US Holdings LLC 0135-0157 0135-0157-07 1 BLISTER PACK in 1 CARTON (0135-0157-07) / 110 GUM, CHEWING in 1 BLISTER PACK
NICORETTE nicotine polacrilex GUM, CHEWING;BUCCAL 018612 NDA Haleon US Holdings LLC 0135-0157 0135-0157-10 1 BLISTER PACK in 1 CARTON (0135-0157-10) / 170 GUM, CHEWING in 1 BLISTER PACK

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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