ANDA 089892

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #089892

Application Sponsors

ANDA 089892

ACTAVIS MID ATLANTIC

Marketing Status

• Discontinued: 001

Application Products

001

SUSPENSION;ORAL

125MG/5ML

0

PHENYTOIN

PHENYTOIN

FDA Submissions

	ORIG	1	AP	1992-09-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-08-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1996-08-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1996-08-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-02-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-02-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2000-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2000-11-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-11-13
LABELING; Labeling	SUPPL	17	AP	2004-03-10

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89892
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENYTOIN","activeIngredients":"PHENYTOIN","strength":"125MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PHENYTOIN","submission":"PHENYTOIN","actionType":"125MG\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)