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

Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Express Scripts
Fuji
Cipla
Healthtrust
US Army
Argus Health
Federal Trade Commission
Harvard Business School

Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076278

« Back to Dashboard

NDA 076278 describes FLECAINIDE ACETATE, which is a drug marketed by Amneal Pharm, Ani Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Idt Australia Ltd, Sun Pharm Inds Ltd, and West-ward Pharms Int, and is included in seven NDAs. It is available from sixteen suppliers. Additional details are available on the FLECAINIDE ACETATE profile page.

The generic ingredient in FLECAINIDE ACETATE is flecainide acetate. There are ten drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the flecainide acetate profile page.
Summary for 076278
Tradename:FLECAINIDE ACETATE
Applicant:West-ward Pharms Int
Ingredient:flecainide acetate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076278
Medical Subject Heading (MeSH) Categories for 076278
Suppliers and Packaging for NDA: 076278
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 076278 ANDA West-Ward Pharmaceuticals Corp. 0054-0010 N 0054-0010-25
FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 076278 ANDA West-Ward Pharmaceuticals Corp. 0054-0010 N 0054-0010-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jan 14, 2003TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jan 14, 2003TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jan 14, 2003TE:ABRLD:No

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Federal Trade Commission
Express Scripts
Teva
Medtronic
Deloitte
Fish and Richardson
Julphar
Mallinckrodt

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.