ANDA 087792

SPECTRUM PHARMS

FDA Drug Application

Application #087792

Application Sponsors

ANDA 087792

SPECTRUM PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

0

FLUOROURACIL

FLUOROURACIL

FDA Submissions

	ORIG	1	AP	1982-10-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-05-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1989-08-29
LABELING; Labeling	SUPPL	6	AP	2016-12-06	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	15

CDER Filings

SPECTRUM PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87792
            [companyName] => SPECTRUM PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOROURACIL","activeIngredients":"FLUOROURACIL","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUOROURACIL","submission":"FLUOROURACIL","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)