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. Ninety-eight 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	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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