MARKSANS PHARMA FDA Approval ANDA 090723

ANDA 090723

MARKSANS PHARMA

FDA Drug Application

Application #090723

Documents

Letter2013-12-13

Application Sponsors

ANDA 090723MARKSANS PHARMA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE, DELAYED REL PELLETS;ORALEQ 20MG BASE0DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDE
002CAPSULE, DELAYED REL PELLETS;ORALEQ 30MG BASE0DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDE
003CAPSULE, DELAYED REL PELLETS;ORALEQ 60MG BASE0DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDE

FDA Submissions

ORIG1AP2013-12-11

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

MARKSANS PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90723
            [companyName] => MARKSANS PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DULOXETINE HYDROCHLORIDE","activeIngredients":"DULOXETINE HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DULOXETINE HYDROCHLORIDE","activeIngredients":"DULOXETINE HYDROCHLORIDE","strength":"EQ 30MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DULOXETINE HYDROCHLORIDE","activeIngredients":"DULOXETINE HYDROCHLORIDE","strength":"EQ 60MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DULOXETINE HYDROCHLORIDE","submission":"DULOXETINE HYDROCHLORIDE","actionType":"EQ 20MG BASE","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DULOXETINE HYDROCHLORIDE","submission":"DULOXETINE HYDROCHLORIDE","actionType":"EQ 30MG BASE","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DULOXETINE HYDROCHLORIDE","submission":"DULOXETINE HYDROCHLORIDE","actionType":"EQ 60MG BASE","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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