ANDA 089521

HOSPIRA

FDA Drug Application

Application #089521

Application Sponsors

ANDA 089521

HOSPIRA

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

0

PHENYTOIN SODIUM

PHENYTOIN SODIUM

FDA Submissions

	ORIG	1	AP	1987-03-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1994-06-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1995-11-30
LABELING; Labeling	SUPPL	11	AP	2014-01-29

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	11	Null	15

CDER Filings

HOSPIRA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89521
            [companyName] => HOSPIRA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENYTOIN SODIUM","activeIngredients":"PHENYTOIN SODIUM","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PHENYTOIN SODIUM","submission":"PHENYTOIN SODIUM","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)