ANDA 090724

AREVA PHARMS

FDA Drug Application

Application #090724

Application Sponsors

ANDA 090724

AREVA PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

50MG/2ML (25MG/ML)

0

FLUDARABINE PHOSPHATE

FLUDARABINE PHOSPHATE

FDA Submissions

ORIG

1

AP

2010-09-27

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

AREVA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90724
            [companyName] => AREVA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUDARABINE PHOSPHATE","activeIngredients":"FLUDARABINE PHOSPHATE","strength":"50MG\/2ML (25MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUDARABINE PHOSPHATE","submission":"FLUDARABINE PHOSPHATE","actionType":"50MG\/2ML (25MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)