.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021224

« Back to Dashboard
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-two suppliers are listed for this compound. There are nine tentative approvals for this compound. Additional details are available on the galantamine hydrobromide profile page.

Summary for NDA: 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

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)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrength4MG/ML
Approval Date:Jun 22, 2001TE:RLD:No

Expired Orange Book Patents for NDA: 021224

These historical archives are available as an add-on to one-year subscriptions.
See the Subscription Options for more information.

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
RAZADYNE
galantamine hydrobromide
SOLUTION;ORAL021224-001Jun 22, 20014,663,318► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

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.

`abc