MYLAN FDA Approval ANDA 203424

ANDA 203424

MYLAN

FDA Drug Application

Application #203424

Application Sponsors

ANDA 203424MYLAN

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

001TABLET;ORAL12.5MG;200MG;50MG0CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA; ENTACAPONE; LEVODOPA
002TABLET;ORAL18.75MG;200MG;75MG0CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA; ENTACAPONE; LEVODOPA
003TABLET;ORAL25MG;200MG;100MG0CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA; ENTACAPONE; LEVODOPA
004TABLET;ORAL31.25MG;200MG;125MG0CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA; ENTACAPONE; LEVODOPA
005TABLET;ORAL37.5MG;200MG;150MG0CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA; ENTACAPONE; LEVODOPA
006TABLET;ORAL50MG;200MG;200MG0CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA; ENTACAPONE; LEVODOPA

FDA Submissions

UNKNOWN; ORIG1AP2020-08-13

Submissions Property Types

ORIG1Null17

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB
006PrescriptionAB

CDER Filings

MYLAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203424
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBIDOPA, LEVODOPA AND ENTACAPONE","activeIngredients":"CARBIDOPA; ENTACAPONE; LEVODOPA","strength":"12.5MG;200MG;50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBIDOPA, LEVODOPA AND ENTACAPONE","activeIngredients":"CARBIDOPA; ENTACAPONE; LEVODOPA","strength":"18.75MG;200MG;75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBIDOPA, LEVODOPA AND ENTACAPONE","activeIngredients":"CARBIDOPA; ENTACAPONE; LEVODOPA","strength":"25MG;200MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBIDOPA, LEVODOPA AND ENTACAPONE","activeIngredients":"CARBIDOPA; ENTACAPONE; LEVODOPA","strength":"31.25MG;200MG;125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBIDOPA, LEVODOPA AND ENTACAPONE","activeIngredients":"CARBIDOPA; ENTACAPONE; LEVODOPA","strength":"37.5MG;200MG;150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBIDOPA, LEVODOPA AND ENTACAPONE","activeIngredients":"CARBIDOPA; ENTACAPONE; LEVODOPA","strength":"50MG;200MG;200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/13\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-13
        )

)

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