ANDA 040781

AM REGENT

FDA Drug Application

Application #040781

Application Sponsors

ANDA 040781

AM REGENT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

0

PHENYTOIN SODIUM

PHENYTOIN SODIUM

FDA Submissions

	ORIG	1	AP	2007-12-04
LABELING; Labeling	SUPPL	2	AP	2015-10-05	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-10-05	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-10-05	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-01-22	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-02-16	STANDARD

Submissions Property Types

SUPPL	2	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	15
SUPPL	6	Null	7
SUPPL	7	Null	7

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40781
            [companyName] => AM REGENT
            [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
        )

)