ANDA 078277

AM REGENT

FDA Drug Application

Application #078277

Documents

• Label: 2007-08-07
• Letter: 2007-08-07

Application Sponsors

ANDA 078277

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	2007-08-06
LABELING; Labeling	SUPPL	2	AP	2013-08-19	STANDARD
LABELING; Labeling	SUPPL	4	AP	2016-06-24	STANDARD

Submissions Property Types

SUPPL	2	Null	8
SUPPL	4	Null	15

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78277
            [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] => [{"actionDate":"08\/06\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/078277s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FOSPHENYTOIN SODIUM","submission":"FOSPHENYTOIN SODIUM","actionType":"EQ 50MG PHENYTOIN NA\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2007-08-06
        )

)