ACS DOBFAR SPA FDA Approval ANDA 065467

ANDA 065467

ACS DOBFAR SPA

FDA Drug Application

Application #065467

Application Sponsors

ANDA 065467ACS DOBFAR SPA

Marketing Status

Discontinued001
Discontinued002

Application Products

001INJECTABLE;INJECTIONEQ 1GM BASE/VIAL0CEFOXITINCEFOXITIN SODIUM
002INJECTABLE;INJECTIONEQ 2GM BASE/VIAL0CEFOXITINCEFOXITIN SODIUM

FDA Submissions

ORIG1AP2011-08-31
LABELING; LabelingSUPPL4AP2016-06-20STANDARD

Submissions Property Types

ORIG1Null7
SUPPL4Null7

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
        )

)

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