Details for New Drug Application (NDA): 075232

NDA 075232 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 075232

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

Pharmacology for NDA: 075232

Mechanism of Action

Opioid Agonists

Medical Subject Heading (MeSH) Categories for 075232

Antidiarrheals

Suppliers and Packaging for NDA: 075232

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	TABLET;ORAL	075232	ANDA	L. Perrigo Company	0113-0224	0113-0224-53	12 BLISTER PACK in 1 CARTON (0113-0224-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK
LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	TABLET;ORAL	075232	ANDA	L. Perrigo Company	0113-0224	0113-0224-62	24 BLISTER PACK in 1 CARTON (0113-0224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Jan 6, 2000	TE:		RLD:	No

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