ANDA 078765

HIKMA FARMACEUTICA

FDA Drug Application

Application #078765

Application Sponsors

ANDA 078765

HIKMA FARMACEUTICA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 50MG PHENYTOIN NA/ML

0

FOSPHENYTOIN SODIUM

FOSPHENYTOIN SODIUM

FDA Submissions

	ORIG	1	AP	2009-12-02
LABELING; Labeling	SUPPL	5	AP	2013-08-14
LABELING; Labeling	SUPPL	7	AP	2018-03-08	STANDARD
LABELING; Labeling	SUPPL	8	AP	2018-03-08	STANDARD
LABELING; Labeling	SUPPL	9	AP	2018-03-08	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	15
SUPPL	7	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	15

TE Codes

001

Prescription

AP

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78765
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOSPHENYTOIN SODIUM","activeIngredients":"FOSPHENYTOIN SODIUM","strength":"EQ 50MG PHENYTOIN NA\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FOSPHENYTOIN SODIUM","submission":"FOSPHENYTOIN SODIUM","actionType":"EQ 50MG PHENYTOIN NA\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)