ANDA 203738

ACTAVIS LLC

FDA Drug Application

Application #203738

Application Sponsors

ANDA 203738

ACTAVIS LLC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

50MG/2ML (25MG/ML)

0

FLUDARABINE PHOSPHATE

FLUDARABINE PHOSPHATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-02-28

Submissions Property Types

ORIG

1

Null

19

TE Codes

001

Prescription

AP

CDER Filings

ACTAVIS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203738
            [companyName] => ACTAVIS LLC
            [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":"02\/28\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-02-28
        )

)