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Serving hundreds of leading biopharmaceutical companies globally:

Generated: April 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021855

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NDA 021855 describes LOPERAMIDE HYDROCHLORIDE, which is a drug marketed by Bionpharma Inc, Mylan, Roxane, Teva, Yaopharma Co Ltd, Allied Pharma Inc, Alpharma Us Pharms, Duramed Pharms Barr, Hi Tech Pharma, Perrigo, Watson Labs, Wockhardt Bio Ag, Perrigo R And D, Able, Aurobindo Pharma Ltd, Contract Pharmacal, L Perrigo Co, LNK, Ohm Labs, and Sun Pharm Inds Ltd, and is included in twenty-four NDAs. It is available from one hundred and seventeen 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. One supplier is listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.

Summary for 021855

Tradename:	LOPERAMIDE HYDROCHLORIDE
Applicant:	Bionpharma Inc
Ingredient:	loperamide hydrochloride
Patents:	0
Therapeutic Class:	Gastrointestinal Agents
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 021855

Antidiarrheals

Suppliers and Packaging for NDA: 021855

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	CAPSULE;ORAL	021855	NDA	Walgreens	0363-0520	N	0363-0520-24
LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	CAPSULE;ORAL	021855	NDA	TARGET Corporation	11673-520	N	11673-520-24

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CAPSULE;ORAL			Strength	1MG
Approval Date:	Aug 4, 2005	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	CAPSULE;ORAL			Strength	2MG
Approval Date:	Aug 4, 2005	TE:		RLD:	Yes

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