ANDA 076421

SUN PHARM INDS LTD

FDA Drug Application

Application #076421

Application Sponsors

ANDA 076421

SUN PHARM INDS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 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

2003-03-28

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76421
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLECAINIDE ACETATE","activeIngredients":"FLECAINIDE ACETATE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLECAINIDE ACETATE","activeIngredients":"FLECAINIDE ACETATE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLECAINIDE ACETATE","activeIngredients":"FLECAINIDE ACETATE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLECAINIDE ACETATE","submission":"FLECAINIDE ACETATE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FLECAINIDE ACETATE","submission":"FLECAINIDE ACETATE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FLECAINIDE ACETATE","submission":"FLECAINIDE ACETATE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)