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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 073080

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NDA 073080 describes LOPERAMIDE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Edenbridge Pharms, Jubilant Cadista, Mylan, Roxane, Rubicon, Strides Pharma, Teva, Zydus Lifesciences, Allied, Alpharma Us Pharms, Duramed Pharms Barr, Perrigo, Sciegen Pharms Inc, Watson Labs, Wockhardt Bio Ag, Perrigo R And D, 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-seven NDAs. It is available from one hundred and four 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-one suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.

Summary for 073080

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

Medical Subject Heading (MeSH) Categories for 073080

Antidiarrheals

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	2MG
Approval Date:	Nov 27, 1991	TE:		RLD:	No

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