CONJUPRO FDA Approval ANDA 213485

ANDA 213485

CONJUPRO

FDA Drug Application

Application #213485

Application Sponsors

ANDA 213485CONJUPRO

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET, EXTENDED RELEASE;ORALEQ 12.5MG BASE0PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDE
002TABLET, EXTENDED RELEASE;ORALEQ 25MG BASE0PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDE
003TABLET, EXTENDED RELEASE;ORALEQ 37.5MG BASE0PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-02-16STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

CSPC OUYI
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213485
            [companyName] => CSPC OUYI
            [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"},{"drugName":"PAROXETINE HYDROCHLORIDE","activeIngredients":"PAROXETINE HYDROCHLORIDE","strength":"EQ 37.5MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/16\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-16
        )

)

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