ANDA 212799

BIONPHARMA INC

FDA Drug Application

Application #212799

Application Sponsors

ANDA 212799

BIONPHARMA INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	10MEQ	0	POTASSIUM CITRATE	POTASSIUM CITRATE
002	TABLET, EXTENDED RELEASE;ORAL	15MEQ	0	POTASSIUM CITRATE	POTASSIUM CITRATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-06-29	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-05-05	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

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
        )

)