CUSTOPHARM INC FDA Approval ANDA 203619

ANDA 203619

CUSTOPHARM INC

FDA Drug Application

Application #203619

Application Sponsors

ANDA 203619CUSTOPHARM INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION50MG/ML0PENTOBARBITAL SODIUMPENTOBARBITAL SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2017-11-13

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

CUSTOPHARM INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203619
            [companyName] => CUSTOPHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PENTOBARBITAL SODIUM","activeIngredients":"PENTOBARBITAL SODIUM","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/13\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-11-13
        )

)

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