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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
McKinsey
Farmers Insurance
Fish and Richardson
AstraZeneca
Moodys
Harvard Business School
Daiichi Sankyo
Citi

Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019527

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NDA 019527 describes PEPCID, which is a drug marketed by Salix Pharms, Merck, Valeant Pharms North, J And J Consumer Inc, and Merck Sharp Dohme, and is included in nine NDAs. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the PEPCID profile page.

The generic ingredient in PEPCID is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and seventy-five drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.
Summary for 019527
Tradename:PEPCID
Applicant:Salix Pharms
Ingredient:famotidine
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 019527
Medical Subject Heading (MeSH) Categories for 019527
Suppliers and Packaging for NDA: 019527
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PEPCID famotidine FOR SUSPENSION;ORAL 019527 NDA Salix Pharmaceuticals, Inc. 65649-211 E 65649-211-24

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength40MG/5ML
Approval Date:Feb 2, 1987TE:ABRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Moodys
Queensland Health
Accenture
AstraZeneca
Chinese Patent Office
Merck
Argus Health
McKesson

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