Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

FDA Approval Activities for this Drug… NicoDerm CQ (nicotine transdermal system) clear and opaque, 21mg, 14mg, and 7 mg GlaxoSmithKline Consumer Healthcare NDA 20-165/S-020 8/13/02 8/14/02 Nicorette Gum, 4 mg SmithKline Beecham Consumer Healthcare NDA 20-066/S10 9/25/00 5/1/02 5/1/02 5/1/02 Nicorette (Nicotine Polacrilex) Gum, 2 & 4 mg SmithKline Beecham Consumer Healthcare NDA 18-612/S031 & 20-066/S13 8/9/02 8/12/02 Nicorette 2 & 4 mg (Nicotine Polacrilex) Gum, SmithKline Beecham Consumer Healthcare NDA 18-612/S025 & 20-066/S7 12/23/1998 5/1/02 5/1/02 5/1/02 Nicotine Polacrilex Gum USP, 2 mg (base) Circa NDA 74-507 3/15/99 3/16/99 4/23/03 Nicotine Polacrilex Gum USP, 4 mg (base). Circa NDA 74-707 3/19/99 3/22/99 4/22/03 Nicotrol Inhaler (nicotine inhalation system), Pharmacia Consumer HealthCare NDA 20-714/S-010 9/8/02 9/11/02 Nicotrol Patch (nicotine transdermal system), 15 mg Pharmacia and Upjohn Company NDA 20-536/S-010 7/23/02 7/24/02 Nicotrol NS (nicotine nasal spray), Pharmacia Consumer Healthcare NDA 20-385/S-005 9/8/02 9/11/02 Nicotrol TD (nicotine transdermal system), Pharmacia Consumer Healthcare NDA 20-150/S-011 ProStep (nicotine transdermal system), 11 mg/day and 22 mg/day patches Elan Drug Delivery, NDA 19-983/S17 10/4/02 10/11/01 ProStep (nicotine transdermal system), 11 mg/day and 22 mg/day patches Elan Pharmaceutical Research NDA 19-983/S16 1/18/02 2/5/02 2/5/02 ProStep (nicotine transdermal system), 11 mg/day and 22 mg/day patches Elan Pharmaceutical Research NDA 19-983/S-012 12/23/98 1/6/99 7/13/00 ProStep Indication: Aid to stop smoking cigarettes (for those over 18 years of age). Nicotrol NS & Inhaler, Pharmacia Consumer Healthcare Habitrol (nicotine) Transdermal System, Novartis Consumer Health, Inc. Habitrol (nicotine) Transdermal System, Novartis Consumer Commit (nicotine polacrilex) Lozenge, GlaxoSmithKline Nicorette (Nicotine Polacrilex) Gum 2mg, GlaxoSmithKline Nicorette Gum 4mg, GlaxoSmithKline Nicotine 074611 NICOTINE FILM, EXTENDED RELEASE; TRANSDERMAL 14MG/24HR NICOTINE SANO 074612 NICOTINE FILM, EXTENDED RELEASE; TRANSDERMAL 21MG/24HR NICOTINE SANO 074645 NICOTINE FILM, EXTENDED RELEASE; TRANSDERMAL 7MG/24HR NICOTINE SANO 020714 NICOTINE INHALANT; ORAL 4MG/CARTRIDGE NICOTROL PHARMACIA AND UPJOHN 020385 NICOTINE SPRAY, METERED; NASAL 0.5MG/SPRAY NICOTROL PHARMACIA AND UPJOHN Habitrol (nicotine) Transdermal System, Novartis Consumer Health, Inc. Habitrol (nicotine) Transdermal System, Novartis Consumer Nicorette (Nicotine Polacrilex) Gum 2mg, GlaxoSmithKline Nicorette Gum 4mg, GlaxoSmithKline Commit (nicotine polacrilex) Lozenge, GlaxoSmithKline Nicorette (2 mg nicotine polacrilex) gum, GlaxoSmithKline Nicorette (4 mg nicotine polacrilex) gum, GlaxoSmithKline Nicorette (2 mg nicotine polacrilex) gum, GlaxoSmithKline Nicorette (4 mg nicotine polacrilex) gum, GlaxoSmithKline Nicotine Polacriles Gum (2mg), Watson Laboratories, Approval Nicotine Polacriles Gum (4mg), Watson Laboratories, Approval   For the latest approval information, locate this drug using this index.