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Serving leading biopharmaceutical companies globally:

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Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079164

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NDA 079164 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 fifteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the flecainide acetate profile page.
Summary for 079164
Tradename:FLECAINIDE ACETATE
Applicant:Apotex Inc
Ingredient:flecainide acetate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 079164
Medical Subject Heading (MeSH) Categories for 079164
Suppliers and Packaging for NDA: 079164
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 079164 ANDA Apotex Corp. 60505-2660 60505-2660-1 100 TABLET in 1 BOTTLE (60505-2660-1)
FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 079164 ANDA Apotex Corp. 60505-2660 60505-2660-0 10 BLISTER PACK in 1 CARTON (60505-2660-0) > 10 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Jul 9, 2009TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Jul 9, 2009TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength150MG
Approval Date:Jul 9, 2009TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
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Fuji
Dow
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McKesson
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