ANDA 208670

BIONPHARMA INC

FDA Drug Application

Application #208670

Application Sponsors

ANDA 208670

BIONPHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

625MG

0

COLESEVELAM HYDROCHLORIDE

COLESEVELAM HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-09-13

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

BIONPHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208670
            [companyName] => BIONPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"COLESEVELAM HYDROCHLORIDE","activeIngredients":"COLESEVELAM HYDROCHLORIDE","strength":"625MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/13\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-09-13
        )

)