Details for New Drug Application (NDA): 074091

NDA 074091 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 074091

Tradename:	LOPERAMIDE HYDROCHLORIDE
Applicant:	Ohm Labs
Ingredient:	loperamide hydrochloride
Patents:	0

Pharmacology for NDA: 074091

Mechanism of Action

Opioid Agonists

Medical Subject Heading (MeSH) Categories for 074091

Antidiarrheals

Suppliers and Packaging for NDA: 074091

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	TABLET;ORAL	074091	ANDA	Lil' Drug Store Products, Inc.	29485-9286	29485-9286-2	25 POUCH in 1 BOX (29485-9286-2) / 1 TABLET in 1 POUCH
LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	TABLET;ORAL	074091	ANDA	Lil' Drug Store Products, Inc.	29485-9286	29485-9286-3	30 POUCH in 1 BOX (29485-9286-3) / 1 TABLET in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Dec 10, 1992	TE:		RLD:	No

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