Application Nr Approved Date Route Status External Links
ANDA075232 2000-01-06 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Anti-Diarrheal

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Anhydrous Lactose ANHYDROUS LACTOSE Molecular
2. Carnauba Wax CARNAUBA WAX Unresolved MISC-Miscellaneous GRAS-Generally recognized as safe.
3. D&c Yellow No. 10 D&C YELLOW NO. 10 Molecular DYE-Dye
4. Hypromelloses HYPROMELLOSES Unresolved
5. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
7. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE ZINC537928

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