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Generated: August 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021169

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NDA 021169 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 suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.

Summary for NDA: 021169

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:2
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021169

Mechanism of ActionCholinesterase Inhibitors

Suppliers and Packaging for NDA: 021169

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RAZADYNE
galantamine hydrobromide
TABLET;ORAL 021169 NDA Patriot Pharmaceuticals, LLC 10147-0881 10147-0881-6 60 TABLET, FILM COATED in 1 BOTTLE (10147-0881-6)
RAZADYNE
galantamine hydrobromide
TABLET;ORAL 021169 NDA Patriot Pharmaceuticals, LLC 10147-0882 10147-0882-6 60 TABLET, FILM COATED in 1 BOTTLE (10147-0882-6)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Feb 28, 2001TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Jun 6, 2017Product Flag?Substance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Jun 6, 2017Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ALZHEIMER'S DEMENTIA

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 8MG BASE
Approval Date:Feb 28, 2001TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Jun 6, 2017Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021169



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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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