LUPIN LTD FDA Approval ANDA 204134

ANDA 204134

LUPIN LTD

FDA Drug Application

Application #204134

Application Sponsors

ANDA 204134LUPIN LTD

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; ORIG1AP2017-01-20

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204134
            [companyName] => LUPIN LTD
            [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":"01\/20\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-01-20
        )

)

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