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U.S. Department of Health and Human Services

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.

 

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