Application Nr Approved Date Route Status External Links
ANDA076789 2004-09-16 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Stop Smoking Aid

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Acesulfame Potassium ACESULFAME POTASSIUM Molecular NNS-Non-nutritive sweetener REG-Food additives for which a petition has been filed and a regulation issued.
2. Calcium Carbonate CALCIUM CARBONATE Molecular DS-Dietary supplement , DYE-Dye , EMUL-Emulsifier , MISC-Miscellaneous , NUTR-Nutrient GRAS-Generally recognized as safe.
3. Carnauba Wax CARNAUBA WAX Unresolved MISC-Miscellaneous GRAS-Generally recognized as safe.
4. D&c Yellow No. 10 D&C YELLOW NO. 10 Molecular DYE-Dye
5. Sodium Bicarbonate SODIUM BICARBONATE Molecular MISC-Miscellaneous , SANI-Sanitizing agent REG-Food additives for which a petition has been filed and a regulation issued.
6. Sodium Carbonate SODIUM CARBONATE Molecular BC-Boiler compound , B&N-Buffer & neutralizing agent GRAS-Generally recognized as safe.
7. Sorbitol SORBITOL Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
8. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Nicotine NICOTINE ZINC391812

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