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Serving leading biopharmaceutical companies globally:

AstraZeneca
Argus Health
Deloitte
Moodys
QuintilesIMS
Queensland Health
Johnson and Johnson
Harvard Business School
Federal Trade Commission
Covington

Generated: January 16, 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 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 65649-211-24 50 mL in 1 BOTTLE (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 leading biopharmaceutical companies globally:

McKinsey
Daiichi Sankyo
Accenture
Cerilliant
Chubb
Johnson and Johnson
UBS
McKesson
Teva

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