Application Nr Approved Date Route Status External Links
NDA021887 2007-02-07 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Weight Loss Aid

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Fd&c Blue No. 2 FD&C BLUE NO. 2 Molecular DYE-Dye
2. Gelatin GELATIN Unresolved
3. Ferric Oxide Red FERRIC OXIDE RED Molecular
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Povidones POVIDONES Unresolved
6. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
7. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
8. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Orlistat ORLISTAT ZINC8214635

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