BIONPHARMA INC FDA Approval ANDA 212799

ANDA 212799

BIONPHARMA INC

FDA Drug Application

Application #212799

Application Sponsors

ANDA 212799BIONPHARMA INC

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, EXTENDED RELEASE;ORAL10MEQ0POTASSIUM CITRATEPOTASSIUM CITRATE
002TABLET, EXTENDED RELEASE;ORAL15MEQ0POTASSIUM CITRATEPOTASSIUM CITRATE

FDA Submissions

UNKNOWN; ORIG1AP2020-06-29STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

BIONPHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212799
            [companyName] => BIONPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CITRATE","activeIngredients":"POTASSIUM CITRATE","strength":"10MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CITRATE","activeIngredients":"POTASSIUM CITRATE","strength":"15MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/29\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-29
        )

)

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