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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson

Generated: March 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075882

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NDA 075882 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 075882
Applicant:Ani Pharms Inc
Ingredient:flecainide acetate
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075882
Medical Subject Heading (MeSH) Categories for 075882
Suppliers and Packaging for NDA: 075882
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 075882 ANDA KAISER FOUNDATION HOSPITALS 0179-0231 N 0179-0231-88
FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 075882 ANDA ANI Pharmaceuticals, Inc. 62559-380 N 62559-380-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Oct 28, 2002TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Oct 28, 2002TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Oct 28, 2002TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
US Army
Express Scripts

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