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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
McKinsey
Covington
US Department of Justice
Boehringer Ingelheim
Harvard Business School
Johnson and Johnson
Cipla
Argus Health
Queensland Health

Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 073192

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NDA 073192 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 nineteen 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 073192
Tradename:LOPERAMIDE HYDROCHLORIDE
Applicant:Teva
Ingredient:loperamide hydrochloride
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 073192
Mechanism of ActionOpioid Agonists
Medical Subject Heading (MeSH) Categories for 073192
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 N 0093-0311-05
LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride CAPSULE;ORAL 073192 ANDA Teva Pharmaceuticals USA, Inc. 0093-0311 N 0093-0311-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2MG
Approval Date:Apr 30, 1992TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Julphar
Daiichi Sankyo
Covington
Fuji
Deloitte
Farmers Insurance
Boehringer Ingelheim
US Department of Justice

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