EDENBRIDGE PHARMS FDA Approval ANDA 203559

ANDA 203559

EDENBRIDGE PHARMS

FDA Drug Application

Application #203559

Documents

Letter2016-12-23

Application Sponsors

ANDA 203559EDENBRIDGE PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001SOLUTION;ORALEQ 10MG BASE/5ML0PREDNISOLONE SODIUM PHOSPHATEPREDNISOLONE SODIUM PHOSPHATE
002SOLUTION;ORALEQ 20MG BASE/5ML0PREDNISOLONE SODIUM PHOSPHATEPREDNISOLONE SODIUM PHOSPHATE

FDA Submissions

UNKNOWN; ORIG1AP2016-12-20

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA
002PrescriptionAA

CDER Filings

EDENBRIDGE PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203559
            [companyName] => EDENBRIDGE PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREDNISOLONE SODIUM PHOSPHATE","activeIngredients":"PREDNISOLONE SODIUM PHOSPHATE","strength":"EQ 10MG BASE\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREDNISOLONE SODIUM PHOSPHATE","activeIngredients":"PREDNISOLONE SODIUM PHOSPHATE","strength":"EQ 20MG BASE\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/20\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203559Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-12-20
        )

)

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