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U.S. Department of Health and Human Services

Tobacco Products

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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.

 

Prescription Smoking Cessation Products - NDAs
Proprietary Name FormulationNDA
Nicotrol NS(nicotine nasal spray, 0.5 mg/spray) (Pfizer)
Generics – No		020385
Nicotrol Inhaler (nicotine inhalation system, 4 mg/cartridge) (Pharmacia)
(n.b., despite the name this product delivers via the oral transmucosal route)
Generics – No		020714
Chantix(varenicline tartrate) (Pfizer)
Generics – No		021928
Zyban(bupropion hydrochloride sustained release) (GSK)
Generics – Yes		020711
Nicorette Gum018612
Nicorette DS Gum020066
Habitrol Transdermal film020076
Nicoderm CQ Transdermal system020165
Commit lozenge021330
Nicorette lozenge022360



 

Prescription Smoking Cessation Products - ANDAs
Proprietary NameApplicant NameANDA
bupropion hydrochlorideActavis77-475
bupropion hydrochlorideIMPAX Laboratories75-914
bupropion hydrochlorideSandoz76-834
Nicotine Film, Extended Release, 7MGAveo74645
Nicotine Film, Extended Release, 14MGAveo74611
Nicotine Film, Extended Release, 21MGAveo74612
Nicotine Polacrilex, Gum, Chewing; Buccal, EQ 2MGIvax Pharmaceuticals76880
Nicotine Polacrilex, Gum, Chewing; Buccal, EQ 4MGIvax Pharmaceuticals77850
Thrive (Nicotine Polacrilex) Gum, Chewing ; Buccal, EQ 2MGNovartis77658
Thrive (Nicotine Polacrilex) Gum, Chewing ; Buccal, EQ 4MGNovartis77656
Nicotine Polacrilex, Gum, Chewing ; Buccal, EQ 2MGPerigo76775, 76777
Nicotine Polacrilex, Gum, Chewing ; Buccal, EQ 4MGPerigo76778, 76779, 76789
Nicotine Polacrilex, Gum, Chewing ; Buccal, EQ 2MGPerigo Research and Development78325, 78547, 78967
Nicotine Polacrilex, Gum, Chewing ; Buccal, EQ 4MGPerigo Research and Development78326, 78546, 78968
Nicotine Polacrilex, Gum, Chewing ; Buccal, EQ 2MGWatson Laboratories74507, 76569, 78699
Nicotine Polacrilex, Gum, Chewing ; Buccal, EQ 4MGWatson Laboratories74707, 76568, 78697
Nicotine Polacrilex, Troche/Lozenge, EQ 2MGPerigo Research and Development77007

 

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

 

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