ANDA 209652

BIONPHARMA INC

FDA Drug Application

Application #209652

Application Sponsors

ANDA 209652

BIONPHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

300MG/5ML

0

OXCARBAZEPINE

OXCARBAZEPINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-11-04

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

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
        )

)