ANDA 090099

AM REGENT

FDA Drug Application

Application #090099

Application Sponsors

ANDA 090099

AM REGENT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 50MG PHENYTOIN NA/ML

0

FOSPHENYTOIN SODIUM

FOSPHENYTOIN SODIUM

FDA Submissions

	ORIG	1	AP	2010-05-13
LABELING; Labeling	SUPPL	3	AP	2016-11-14	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90099
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOSPHENYTOIN SODIUM","activeIngredients":"FOSPHENYTOIN SODIUM","strength":"EQ 50MG PHENYTOIN NA\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FOSPHENYTOIN SODIUM","submission":"FOSPHENYTOIN SODIUM","actionType":"EQ 50MG PHENYTOIN NA\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)