ANDA 079164

APOTEX INC

FDA Drug Application

Application #079164

Application Sponsors

ANDA 079164

APOTEX INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	50MG	0	FLECAINIDE ACETATE	FLECAINIDE ACETATE
002	TABLET;ORAL	100MG	0	FLECAINIDE ACETATE	FLECAINIDE ACETATE
003	TABLET;ORAL	150MG	0	FLECAINIDE ACETATE	FLECAINIDE ACETATE

FDA Submissions

ORIG

1

AP

2009-07-09

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79164
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLECAINIDE ACETATE","activeIngredients":"FLECAINIDE ACETATE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FLECAINIDE ACETATE","activeIngredients":"FLECAINIDE ACETATE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FLECAINIDE ACETATE","activeIngredients":"FLECAINIDE ACETATE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLECAINIDE ACETATE","submission":"FLECAINIDE ACETATE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FLECAINIDE ACETATE","submission":"FLECAINIDE ACETATE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FLECAINIDE ACETATE","submission":"FLECAINIDE ACETATE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)