ANDA 209374

BIONPHARMA INC

FDA Drug Application

Application #209374

Application Sponsors

ANDA 209374

BIONPHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

FOR SUSPENSION;ORAL

800MG/PACKET

0

SEVELAMER CARBONATE

SEVELAMER CARBONATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-05-17

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

BIONPHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209374
            [companyName] => BIONPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SEVELAMER CARBONATE","activeIngredients":"SEVELAMER CARBONATE","strength":"800MG\/PACKET","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/17\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-17
        )

)