ANDA 215563

NOVITIUM PHARMA

FDA Drug Application

Application #215563

Application Sponsors

ANDA 215563

NOVITIUM PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	5MG	0	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE
002	TABLET;ORAL	10MG	0	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-10-29

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

NOVITIUM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215563
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BISOPROLOL FUMARATE","activeIngredients":"BISOPROLOL FUMARATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BISOPROLOL FUMARATE","activeIngredients":"BISOPROLOL FUMARATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/29\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-29
        )

)