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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075442

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NDA 075442 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 075442

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075442

Medical Subject Heading (MeSH) Categories for 075442

Suppliers and Packaging for NDA: 075442

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 075442 ANDA AvKARE, Inc. 42291-293 42291-293-01 100 TABLET in 1 BOTTLE (42291-293-01)
FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 075442 ANDA AvKARE, Inc. 42291-294 42291-294-01 100 TABLET in 1 BOTTLE (42291-294-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jul 31, 2001TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jul 31, 2001TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jul 31, 2001TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

US Army
Farmers Insurance
Boehringer Ingelheim
Johnson and Johnson

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