BIONPHARMA INC FDA Approval ANDA 209652

ANDA 209652

BIONPHARMA INC

FDA Drug Application

Application #209652

Application Sponsors

ANDA 209652BIONPHARMA INC

Marketing Status

Prescription001

Application Products

001SUSPENSION;ORAL300MG/5ML0OXCARBAZEPINEOXCARBAZEPINE

FDA Submissions

UNKNOWN; ORIG1AP2022-11-04STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

BIONPHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209652
            [companyName] => BIONPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXCARBAZEPINE","activeIngredients":"OXCARBAZEPINE","strength":"300MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OXCARBAZEPINE","submission":"OXCARBAZEPINE","actionType":"300MG\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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