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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Federal Trade Commission
Medtronic
Dow
Covington
Merck
US Army
Harvard Business School
Deloitte
Queensland Health

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021224

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NDA 021224 describes RAZADYNE, which is a drug marketed by Janssen Pharms and is included in three NDAs. It is available from five suppliers. There are three patents protecting this drug and three Paragraph IV challenges. Additional details are available on the RAZADYNE profile page.

The generic ingredient in RAZADYNE is galantamine hydrobromide. There are fifteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.
Summary for 021224
Tradename:RAZADYNE
Applicant:Janssen Pharms
Ingredient:galantamine hydrobromide
Patents:0
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 021224
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 021224
Suppliers and Packaging for NDA: 021224
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RAZADYNE galantamine hydrobromide SOLUTION;ORAL 021224 NDA Janssen Pharmaceuticals, Inc. 50458-490 50458-490-10 100 mL in 1 BOTTLE (50458-490-10)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrength4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jun 22, 2001TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Healthtrust
Harvard Business School
UBS
Accenture
Moodys
Queensland Health
Daiichi Sankyo
Cerilliant
Johnson and Johnson

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