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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 074991

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NDA 074991 describes LOPERAMIDE HYDROCHLORIDE, which is a drug marketed by 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, Aurobindo Pharma, Contract Pharmacal, L Perrigo Co, LNK, Ohm Labs, Granules, Guardian Drug, Hetero Labs Ltd V, and Sun Pharm Inds Ltd, and is included in thirty-eight NDAs. It is available from ninety-eight 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 074991

Tradename:	LOPERAMIDE HYDROCHLORIDE
Applicant:	Duramed Pharms Barr
Ingredient:	loperamide hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 074991

Antidiarrheals

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	1MG/5ML
Approval Date:	Dec 29, 1997	TE:		RLD:	No

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