ANDA 076349

CUSTOPHARM INC

FDA Drug Application

Application #076349

Documents

• Review: 2007-04-02

Application Sponsors

ANDA 076349

CUSTOPHARM INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

50MG/VIAL

0

FLUDARABINE PHOSPHATE

FLUDARABINE PHOSPHATE

FDA Submissions

	ORIG	1	AP	2003-08-28
LABELING; Labeling	SUPPL	4	AP	2011-03-21
LABELING; Labeling	SUPPL	14	AP	2011-12-08

Submissions Property Types

SUPPL

14

Null

15

TE Codes

001

Prescription

AP

CDER Filings

CUSTOPHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76349
            [companyName] => CUSTOPHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUDARABINE PHOSPHATE","activeIngredients":"FLUDARABINE PHOSPHATE","strength":"50MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUDARABINE PHOSPHATE","submission":"FLUDARABINE PHOSPHATE","actionType":"50MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)