SUNSHINE FDA Approval ANDA 212328

ANDA 212328

SUNSHINE

FDA Drug Application

Application #212328

Application Sponsors

ANDA 212328SUNSHINE

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

UNKNOWN; ORIG1AP2021-02-11STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

SUNSHINE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212328
            [companyName] => SUNSHINE
            [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":"02\/11\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-11
        )

)

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