SINOTHERAPEUTICS INC FDA Approval ANDA 213612

ANDA 213612

SINOTHERAPEUTICS INC

FDA Drug Application

Application #213612

Application Sponsors

ANDA 213612SINOTHERAPEUTICS INC

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, EXTENDED RELEASE;ORALEQ 12.5MG BASE0PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDE
002TABLET, EXTENDED RELEASE;ORALEQ 25MG BASE0PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-08-11STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

SINOTHERAPEUTICS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213612
            [companyName] => SINOTHERAPEUTICS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PAROXETINE HYDROCHLORIDE","activeIngredients":"PAROXETINE HYDROCHLORIDE","strength":"EQ 12.5MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PAROXETINE HYDROCHLORIDE","activeIngredients":"PAROXETINE HYDROCHLORIDE","strength":"EQ 25MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/11\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-11
        )

)

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