Details for New Drug Application (NDA): 019037

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NDA 019037 describes IMODIUM, which is a drug marketed by J And J Consumer Inc, Janssen Pharms, and Kenvue Brands, and is included in eight NDAs. Additional details are available on the IMODIUM profile page.

The generic ingredient in IMODIUM is loperamide hydrochloride; simethicone. There are eleven drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.

Summary for 019037

Tradename:	IMODIUM
Applicant:	Janssen Pharms
Ingredient:	loperamide hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 019037

Antidiarrheals

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	1MG/5ML
Approval Date:	Jul 31, 1984	TE:		RLD:	No

Expired US Patents for NDA 019037

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	IMODIUM	loperamide hydrochloride	SOLUTION;ORAL	019037-001	Jul 31, 1984	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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