RUBICON FDA Approval ANDA 216505

ANDA 216505

RUBICON

FDA Drug Application

Application #216505

Application Sponsors

ANDA 216505RUBICON

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL10MG;100MG0CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPA
002TABLET;ORAL25MG;100MG0CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPA
003TABLET;ORAL25MG;250MG0CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPA

FDA Submissions

UNKNOWN; ORIG1AP2022-09-21STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

RUBICON
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216505
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBIDOPA AND LEVODOPA","activeIngredients":"CARBIDOPA; LEVODOPA","strength":"10MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBIDOPA AND LEVODOPA","activeIngredients":"CARBIDOPA; LEVODOPA","strength":"25MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBIDOPA AND LEVODOPA","activeIngredients":"CARBIDOPA; LEVODOPA","strength":"25MG;250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/21\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-21
        )

)

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