ANDA 065464

ACS DOBFAR SPA

FDA Drug Application

Application #065464

Application Sponsors

ANDA 065464

ACS DOBFAR SPA

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 10GM BASE/VIAL

0

CEFOXITIN

CEFOXITIN SODIUM

FDA Submissions

	ORIG	1	AP	2011-08-31
LABELING; Labeling	SUPPL	4	AP	2016-06-20	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	7

CDER Filings

ACS DOBFAR SPA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65464
            [companyName] => ACS DOBFAR SPA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFOXITIN","activeIngredients":"CEFOXITIN SODIUM","strength":"EQ 10GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFOXITIN","submission":"CEFOXITIN SODIUM","actionType":"EQ 10GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)