ANDA 089441

ANI PHARMS INC

FDA Drug Application

Application #089441

Application Sponsors

ANDA 089441

ANI PHARMS INC

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

100MG EXTENDED

0

EXTENDED PHENYTOIN SODIUM

PHENYTOIN SODIUM

FDA Submissions

	ORIG	1	AP	1986-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1994-05-11
LABELING; Labeling	SUPPL	3	AP	1999-02-03
LABELING; Labeling	SUPPL	5	AP	1999-10-19

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0

CDER Filings

ANI PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89441
            [companyName] => ANI PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"EXTENDED PHENYTOIN SODIUM","activeIngredients":"PHENYTOIN SODIUM","strength":"100MG EXTENDED","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"EXTENDED PHENYTOIN SODIUM","submission":"PHENYTOIN SODIUM","actionType":"100MG EXTENDED","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)