ANDA 202538

BIONPHARMA INC

FDA Drug Application

Application #202538

Application Sponsors

ANDA 202538

BIONPHARMA INC

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

10MG

0

LORATADINE

LORATADINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-12-21

Submissions Property Types

ORIG

1

Null

3

CDER Filings

BIONPHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202538
            [companyName] => BIONPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORATADINE","activeIngredients":"LORATADINE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/21\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-12-21
        )

)