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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 019487

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NDA 019487 describes IMODIUM A-D, which is a drug marketed by Kenvue Brands and J And J Consumer Inc and is included in three NDAs. It is available from one supplier. Additional details are available on the IMODIUM A-D profile page.

The generic ingredient in IMODIUM A-D is loperamide hydrochloride. There are eleven drug master file entries for this compound. One hundred and one suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride profile page.

Summary for 019487

Tradename:	IMODIUM A-D
Applicant:	Kenvue Brands
Ingredient:	loperamide hydrochloride
Patents:	0

Pharmacology for NDA: 019487

Mechanism of Action	Opioid Agonists

Medical Subject Heading (MeSH) Categories for 019487

Antidiarrheals

Suppliers and Packaging for NDA: 019487

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IMODIUM A-D	loperamide hydrochloride	SOLUTION;ORAL	019487	NDA	Kenvue Brands LLC	50580-134	50580-134-04	120 mL in 1 BOTTLE (50580-134-04)
IMODIUM A-D	loperamide hydrochloride	SOLUTION;ORAL	019487	NDA	Kenvue Brands LLC	50580-134	50580-134-08	240 mL in 1 BOTTLE (50580-134-08)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	1MG/5ML
Approval Date:	Mar 1, 1988	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	SOLUTION;ORAL			Strength	1MG/7.5ML
Approval Date:	Jul 8, 2004	TE:		RLD:	Yes

Expired US Patents for NDA 019487

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kenvue Brands	IMODIUM A-D	loperamide hydrochloride	SOLUTION;ORAL	019487-001	Mar 1, 1988	3,714,159	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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