Application Nr Approved Date Route Status External Links
ANDA073192 1992-04-30 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications & Usage Loperamide Hydrochloride Capsules Are Indicated For The Control And Symptomatic Relief Of Acute Nonspecific Diarrhea And Of Chronic Diarrhea Associated With Inflammatory Bowel Disease. Loperamide Hydrochloride Capsules Are Also Indicated For Reducing The Volume Of Discharge From Ileostomies.

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Dimethicone DIMETHICONE Molecular
2. Gelatin GELATIN Unresolved
3. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
4. Ferric Oxide Red FERRIC OXIDE RED Molecular
5. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
6. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
7. 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.
8. Shellac SHELLAC Unresolved

Active Ingredients ( 1 Total)

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

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