CSPC OUYI FDA Approval ANDA 213311

ANDA 213311

CSPC OUYI

FDA Drug Application

Application #213311

Application Sponsors

ANDA 213311CSPC OUYI

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET, EXTENDED RELEASE;ORAL100MG0CARBAMAZEPINECARBAMAZEPINE
002TABLET, EXTENDED RELEASE;ORAL200MG0CARBAMAZEPINECARBAMAZEPINE
003TABLET, EXTENDED RELEASE;ORAL400MG0CARBAMAZEPINECARBAMAZEPINE

FDA Submissions

UNKNOWN; ORIG1AP2021-04-13STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

CSPC OUYI
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213311
            [companyName] => CSPC OUYI
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBAMAZEPINE","activeIngredients":"CARBAMAZEPINE","strength":"100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBAMAZEPINE","activeIngredients":"CARBAMAZEPINE","strength":"200MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBAMAZEPINE","activeIngredients":"CARBAMAZEPINE","strength":"400MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/13\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-13
        )

)

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