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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 074194

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NDA 074194 describes LOPERAMIDE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Edenbridge Pharms, Jubilant Cadista, Mylan, Onesource Specialty, Roxane, Rubicon Research, Teva, Zydus Lifesciences, Allied, Alpharma Us Pharms, Duramed Pharms Barr, Pai Holdings, Perrigo, Perrigo R And D, Watson Labs, Wockhardt Bio Ag, Able, Contract Pharmacal, L Perrigo Co, LNK, Marksans Pharma, Ohm Labs, Granules, Guardian Drug, Hetero Labs Ltd V, and Sun Pharm Inds Ltd, and is included in forty NDAs. It is available from one hundred and two suppliers. Additional details are available on the LOPERAMIDE HYDROCHLORIDE profile page.

The generic ingredient in LOPERAMIDE HYDROCHLORIDE 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 074194

Tradename:	LOPERAMIDE HYDROCHLORIDE
Applicant:	Perrigo
Ingredient:	loperamide hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 074194

Antidiarrheals

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Oct 30, 1992	TE:		RLD:	No

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