HETERO LABS LTD V FDA Approval ANDA 204787

ANDA 204787

HETERO LABS LTD V

FDA Drug Application

Application #204787

Application Sponsors

ANDA 204787HETERO LABS LTD V

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2022-03-17STANDARD

Submissions Property Types

ORIG1Null1

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

HETERO LABS LTD V
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204787
            [companyName] => HETERO LABS LTD V
            [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":"LACOSAMIDE","submission":"LACOSAMIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LACOSAMIDE","submission":"LACOSAMIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LACOSAMIDE","submission":"LACOSAMIDE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LACOSAMIDE","submission":"LACOSAMIDE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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