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IMODIUM MULTI-SYMPTOM RELIEF

NDA · New Drug Application · Sponsor: KENVUE BRANDS · Approved 2000-11-30

Drug application

FDA Application #

NDA021140

Application type

New Drug Application

Brand name

IMODIUM MULTI-SYMPTOM RELIEF

Generic name

LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE

Active ingredients

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

Dosage form

TABLET

Route

ORAL

Marketing status

Over-the-counter

Sponsor

KENVUE BRANDS

Manufacturer

Kenvue Brands LLC

First approval

2000-11-30

Source

Authoritative

Drugs@FDA application overview

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