ANDA 076661

SAGENT PHARMS INC

FDA Drug Application

Application #076661

Application Sponsors

ANDA 076661

SAGENT PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

50MG/2ML (25MG/ML)

0

FLUDARABINE PHOSPHATE

FLUDARABINE PHOSPHATE

FDA Submissions

	ORIG	1	AP	2004-04-28
LABELING; Labeling	SUPPL	14	AP	2015-06-14

Submissions Property Types

SUPPL

14

Null

7

TE Codes

001

Prescription

AP

CDER Filings

SAGENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76661
            [companyName] => SAGENT PHARMS INC
            [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
        )

)