ACS DOBFAR FDA Approval ANDA 065415

ANDA 065415

ACS DOBFAR

FDA Drug Application

Application #065415

Application Sponsors

ANDA 065415ACS DOBFAR

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTIONEQ 10GM BASE/VIAL0CEFOXITINCEFOXITIN SODIUM

FDA Submissions

ORIG1AP2010-05-19
LABELING; LabelingSUPPL2AP2012-05-02

Submissions Property Types

ORIG1Null7
SUPPL2Null15

TE Codes

001PrescriptionAP

CDER Filings

ACS DOBFAR
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65415
            [companyName] => ACS DOBFAR
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFOXITIN","activeIngredients":"CEFOXITIN SODIUM","strength":"EQ 10GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFOXITIN","submission":"CEFOXITIN SODIUM","actionType":"EQ 10GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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