ANDA 210683

BEXIMCO PHARMS USA

FDA Drug Application

Application #210683

Application Sponsors

ANDA 210683

BEXIMCO PHARMS USA

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

UNKNOWN;

ORIG

1

AP

2020-09-16

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

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
        )

)