HIKMA FARMACEUTICA FDA Approval ANDA 065239

ANDA 065239

HIKMA FARMACEUTICA

FDA Drug Application

Application #065239

Application Sponsors

ANDA 065239HIKMA FARMACEUTICA

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTIONEQ 10GM BASE/VIAL0CEFOXITINCEFOXITIN SODIUM

FDA Submissions

ORIG1AP2010-02-26

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

HIKMA FARMACEUTICA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65239
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFOXITIN","activeIngredients":"CEFOXITIN SODIUM","strength":"EQ 10GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [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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