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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 076029

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NDA 076029 describes LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, which is a drug marketed by Perrigo, Aurobindo Pharma Ltd, Bionpharma, Granules, Guardian Drug, Hetero Labs Ltd V, Perrigo R And D, and Sun Pharm Inds Ltd, and is included in eight NDAs. It is available from thirty-four suppliers. Additional details are available on the LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE profile page.

The generic ingredient in LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 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 076029

Tradename:	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
Applicant:	Perrigo
Ingredient:	loperamide hydrochloride; simethicone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, CHEWABLE;ORAL			Strength	2MG;125MG
Approval Date:	Aug 30, 2002	TE:		RLD:	No

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