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FDA Drug information

Loperamide hydrochloride

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


Effective Time

20230619

Version

1

Spl Product Data Elements

Loperamide hydrochloride Loperamide hydrochloride LOPERAMIDE HYDROCHLORIDE LOPERAMIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 101 MICROCRYSTALLINE CELLULOSE 102 POTASSIUM HYDROXIDE POVIDONE K30 SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A TITANIUM DIOXIDE cream opaque cap cream opaque body 1701

Application Number

ANDA217471

Brand Name

Loperamide hydrochloride

Generic Name

Loperamide hydrochloride

Product Ndc

70771-1769

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Loperamide hydrochloride capsules USP, 2 mg NDC 70771-1769-1 100 capsules Rx only 2 mg 100s count

Drug section

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