BEXIMCO PHARMS USA FDA Approval ANDA 210683

ANDA 210683

BEXIMCO PHARMS USA

FDA Drug Application

Application #210683

Application Sponsors

ANDA 210683BEXIMCO PHARMS USA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2020-09-16STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

BEXIMCO PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210683
            [companyName] => BEXIMCO PHARMS USA
            [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":"09\/16\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-16
        )

)

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