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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 | Nicotine Polacrilex Gum (2mg Mint), L. Perrigo Co., Approval | | Nicotine Polacrilex Gum (2mg Orange), L. Perrigo Co., Approval | Nicotine Polacrilex Gum (2mg Regular), L. Perrigo Co., Approval | Nicotine Polacrilex Gum (4mg Mint), L. Perrigo Co., Approval | Nicotine Polacrilex Gum (4mg Orange), L. Perrigo Co., Approval | Nicotine Polacrilex Gum (4mg Regular), L. Perrigo Co., Approval | Habitrol (nicotine transdermal system), Novartis, Package Change | Commit (nicotine polacrilex) Lozenge, GlaxoSmithKline, Package Change | Nicorette (nicotine polacrilex) gum, GlaxoSmithKline, Formulation Revision | Nicorette (nicotine polacrilex) gum, GlaxoSmithKline, Labeling Revision | Habitrol (nicotine transdermal system) patch, Novartis, Labeling Revision | Commit (nicotine polacrilex) Lozenge, GlaxoSmithKline, Package Change | Nicoderm CQ (nicotine transdermal system) transdermal patch, Sanofi-Aventis, Labeling Revision | Nicotine Polacrilex Gum, L. Perrigo Co., Approval
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