YICHANG HUMANWELL FDA Approval ANDA 215599

ANDA 215599

YICHANG HUMANWELL

FDA Drug Application

Application #215599

Application Sponsors

ANDA 215599YICHANG HUMANWELL

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2022-09-08STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

YICHANG HUMANWELL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215599
            [companyName] => YICHANG HUMANWELL
            [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
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.