ANDA 203559

EDENBRIDGE PHARMS

FDA Drug Application

Application #203559

Documents

• Letter: 2016-12-23

Application Sponsors

ANDA 203559

EDENBRIDGE PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;ORAL	EQ 10MG BASE/5ML	0	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE
002	SOLUTION;ORAL	EQ 20MG BASE/5ML	0	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-12-20

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AA
002	Prescription	AA

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
        )

)