ANDA 040765

AMNEAL PHARMS NY

FDA Drug Application

Application #040765

Application Sponsors

ANDA 040765

AMNEAL PHARMS NY

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

100MG EXTENDED

0

EXTENDED PHENYTOIN SODIUM

PHENYTOIN SODIUM

FDA Submissions

	ORIG	1	AP	2008-11-12
LABELING; Labeling	SUPPL	4	AP	2013-12-31
LABELING; Labeling	SUPPL	5	AP	2014-01-03
LABELING; Labeling	SUPPL	8	AP	2014-01-03

Submissions Property Types

SUPPL	4	Null	15
SUPPL	5	Null	15
SUPPL	8	Null	15

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL PHARMS NY

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40765
            [companyName] => AMNEAL PHARMS NY
            [docInserts] => ["",""]
            [products] => [{"drugName":"EXTENDED PHENYTOIN SODIUM","activeIngredients":"PHENYTOIN SODIUM","strength":"100MG EXTENDED","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"EXTENDED PHENYTOIN SODIUM","submission":"PHENYTOIN SODIUM","actionType":"100MG EXTENDED","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)