Application Nr Approved Date Route Status External Links
ANDA072741 1991-09-18 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Loperamide Hydrochloride Capsules Are Indicated For The Control And Symptomatic Relief Of Acute Nonspecific Diarrhea In Patients 2 Years Of Age And Older And Of Chronic Diarrhea In Adults Associated With Inflammatory Bowel Disease. Loperamide Hydrochloride Capsules Are Also Indicated For Reducing The Volume Of Discharge From Ileostomies.

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Gelatin GELATIN Unresolved
4. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
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. Ferric Oxide Red FERRIC OXIDE RED Molecular
8. 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.
9. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

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

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