SUN PHARM INDS LTD FDA Approval ANDA 076421

ANDA 076421

SUN PHARM INDS LTD

FDA Drug Application

Application #076421

Application Sponsors

ANDA 076421SUN PHARM INDS LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL50MG0FLECAINIDE ACETATEFLECAINIDE ACETATE
002TABLET;ORAL100MG0FLECAINIDE ACETATEFLECAINIDE ACETATE
003TABLET;ORAL150MG0FLECAINIDE ACETATEFLECAINIDE ACETATE

FDA Submissions

ORIG1AP2003-03-28

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

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
        )

)

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