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Serving leading biopharmaceutical companies globally:

US Army
Deloitte
Chinese Patent Office
Federal Trade Commission
Johnson and Johnson
Healthtrust
Accenture
Covington
Cerilliant
Medtronic

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 073079

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NDA 073079 describes LOPERAMIDE HYDROCHLORIDE, which is a drug marketed by Bionpharma Inc, Mylan, Roxane, Sandoz, Teva, Allied Pharma Inc, Alpharma Us Pharms, Duramed Pharms Barr, Hi Tech Pharma, Perrigo, Watson Labs, Wockhardt, 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 twenty 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 073079
Tradename:LOPERAMIDE HYDROCHLORIDE
Applicant:Allied Pharma Inc
Ingredient:loperamide hydrochloride
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 073079
Ingredient-typeBenzodiazepines
Mechanism of ActionOpioid Agonists
Medical Subject Heading (MeSH) Categories for 073079
Suppliers and Packaging for NDA: 073079
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride SOLUTION;ORAL 073079 ANDA Physicians Total Care, Inc. 54868-6010 54868-6010-0 30 mL in 1 BOTTLE, DROPPER (54868-6010-0)
LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride SOLUTION;ORAL 073079 ANDA Cardinal Health 55154-4944 55154-4944-5 5 CUP, UNIT-DOSE in 1 BAG (55154-4944-5) > 10 mL in 1 CUP, UNIT-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION;ORALStrength1MG/5ML
Approval Date:Apr 30, 1992TE:RLD:No

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Serving leading biopharmaceutical companies globally:

UBS
Teva
Medtronic
Argus Health
Fuji
US Army
Chubb
QuintilesIMS
Healthtrust

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