Tobacco Products
Smoking Cessation Products to Help You Quit
FDA Approved Smoking Cessation Products Currently Marketed
as of June 12, 2009
To find further information on the products listed below visit Drugs@FDA.
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Prescription Smoking Cessation Products |
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Proprietary Name Formulation |
NDA |
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Nicotrol NS(nicotine nasal spray, 0.5 mg/spray) (Pfizer)
Generics – No
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020385
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Nicotrol Inhaler (nicotine inhalation system, 4 mg/cartridge).(Pharmacia) (n.b., despite the name this product delivers via the oral transmucosal route)
Generics – No
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020714
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Chantix(varenicline tartrate) (Pfizer)
Generics - No
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021928
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Zyban(bupropion hydrochloride sustained release) (GSK)
Generics – YES
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020711
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Proprietary Name |
ANDA |
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bupropion hydrochloride
Applicant - Actavis
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77-475
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bupropion hydrochloride
Applicant - IMPAX Laboratories
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75-914
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bupropion hydrochloride
Applicant - Sandoz
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76-834
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Proprietary Name Formulation |
NDA |
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Nicorette Gum |
018612 |
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Nicorette DS Gum |
020066 |
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Habitrol Transdermal film |
020076 |
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Nicoderm CQ Transdermal system |
020165 |
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Commit lozenge |
021330 |
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Nicorette lozenge |
022360 |
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Proprietary Name |
ANDA |
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Nicotine Film, Extended Release, 14MG Nicotine Film, Extended Release, 21MG Nicotine Film, Extended Release, 7MG
Applicant – Aveo |
74611 74612 74645
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Nicotine Polacrilex, Gum, Chewing ; Buccal, EQ 2MG Nicotine Polacrilex, Gum, Chewing ; Buccal, EQ 4MG
Applicant – Ivax Pharmaceuticals
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76880 77850 |
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Thrive (Nicotine Polacrilex) Gum, Chewing ; Buccal, EQ 2MG Thrive (Nicotine Polacrilex) Gum, Chewing ; Buccal, EQ 4MG
Applicant – Novartis
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77658 77656
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Nicotine Polacrilex, Gum, Chewing ; Buccal, EQ 2MG Nicotine Polacrilex, Gum, Chewing ; Buccal, EQ 2MG Nicotine Polacrilex, Gum, Chewing ; Buccal, EQ 2MG Nicotine Polacrilex, Gum, Chewing ; Buccal, EQ 4MG Nicotine Polacrilex, Gum, Chewing ; Buccal, EQ 4MG Nicotine Polacrilex, Gum, Chewing ; Buccal, EQ 4MG
Applicant – Perigo
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76777 76777 76775 76789 76778 76779
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Nicotine Polacrilex, Gum, Chewing ; Buccal, EQ 2MG Nicotine Polacrilex, Gum, Chewing ; Buccal, EQ 2MG Nicotine Polacrilex, Gum, Chewing ; Buccal, EQ 2MG Nicotine Polacrilex, Gum, Chewing ; Buccal, EQ 4MG Nicotine Polacrilex, Gum, Chewing ; Buccal, EQ 4MG Nicotine Polacrilex, Gum, Chewing ; Buccal, EQ 4MG
Applicant – Perigo Research and Development
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78325 78967 78547 78546 78968 78326
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Nicotine Polacrilex, Gum, Chewing ; Buccal, EQ 2MG Nicotine Polacrilex, Gum, Chewing ; Buccal, EQ 2MG Nicotine Polacrilex, Gum, Chewing ; Buccal, EQ 2MG Nicotine Polacrilex, Gum, Chewing ; Buccal, EQ 4MG Nicotine Polacrilex, Gum, Chewing ; Buccal, EQ 4MG Nicotine Polacrilex, Gum, Chewing ; Buccal, EQ 4MG
Applicant – Watson Laboratories
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74507 78699 76569 74707 76568 78697
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Nicotine Polacrilex, Troche/Lozenge, EQ 2MG Nicotine Polacrilex, Troche/Lozenge, EQ 4MG
Applicant – Perigo Research and Development
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77007
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For OTC Products:
- All of the OTC smoking cessation products are approved for OTC use in adults 18 years of age and older.
- Users under the age of 18 are to ask a doctor before use.
- People who continue to smoke, chew tobacco, use snuff or use a nicotine patch or other nicotine containing products should not use.
- All OTC products have the same indication