APOTEX FDA Approval ANDA 214567

ANDA 214567

APOTEX

FDA Drug Application

Application #214567

Application Sponsors

ANDA 214567APOTEX

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL50MG0LACOSAMIDELACOSAMIDE
002TABLET;ORAL100MG0LACOSAMIDELACOSAMIDE
003TABLET;ORAL150MG0LACOSAMIDELACOSAMIDE
004TABLET;ORAL200MG0LACOSAMIDELACOSAMIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-09-23STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

APOTEX
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214567
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"LACOSAMIDE","activeIngredients":"LACOSAMIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LACOSAMIDE","activeIngredients":"LACOSAMIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LACOSAMIDE","activeIngredients":"LACOSAMIDE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LACOSAMIDE","activeIngredients":"LACOSAMIDE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/23\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-23
        )

)

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