Details for New Drug Application (NDA): 073192

NDA 073192 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 suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.

Summary for 073192

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

Pharmacology for NDA: 073192

Mechanism of Action

Opioid Agonists

Medical Subject Heading (MeSH) Categories for 073192

Antidiarrheals

Suppliers and Packaging for NDA: 073192

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	CAPSULE;ORAL	073192	ANDA	Teva Pharmaceuticals USA, Inc.	0093-0311	0093-0311-01	100 CAPSULE in 1 BOTTLE (0093-0311-01)
LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	CAPSULE;ORAL	073192	ANDA	Teva Pharmaceuticals USA, Inc.	0093-0311	0093-0311-05	500 CAPSULE in 1 BOTTLE (0093-0311-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	2MG
Approval Date:	Apr 30, 1992	TE:	AB	RLD:	No

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