ANDA 065467

ACS DOBFAR SPA

FDA Drug Application

Application #065467

Application Sponsors

ANDA 065467

ACS DOBFAR SPA

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	0	CEFOXITIN	CEFOXITIN SODIUM
002	INJECTABLE;INJECTION	EQ 2GM 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] => 65467
            [companyName] => ACS DOBFAR SPA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFOXITIN","activeIngredients":"CEFOXITIN SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CEFOXITIN","activeIngredients":"CEFOXITIN SODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFOXITIN","submission":"CEFOXITIN SODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CEFOXITIN","submission":"CEFOXITIN SODIUM","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)