SCIEGEN PHARMS INC FDA Approval ANDA 214091

ANDA 214091

SCIEGEN PHARMS INC

FDA Drug Application

Application #214091

Application Sponsors

ANDA 214091SCIEGEN PHARMS INC

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, EXTENDED RELEASE;ORAL25MG;100MG0CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPA
002TABLET, EXTENDED RELEASE;ORAL50MG;200MG0CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPA

FDA Submissions

UNKNOWN; ORIG1AP2021-10-05STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

SCIEGEN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214091
            [companyName] => SCIEGEN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBIDOPA AND LEVODOPA","activeIngredients":"CARBIDOPA; LEVODOPA","strength":"25MG;100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBIDOPA AND LEVODOPA","activeIngredients":"CARBIDOPA; LEVODOPA","strength":"50MG;200MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/05\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-05
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.