ANDA 212019

RISING

FDA Drug Application

Application #212019

Application Sponsors

ANDA 212019

RISING

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	0.5MG	0	BUMETANIDE	BUMETANIDE
002	TABLET;ORAL	1MG	0	BUMETANIDE	BUMETANIDE
003	TABLET;ORAL	2MG	0	BUMETANIDE	BUMETANIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-12-12

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

RISING

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212019
            [companyName] => RISING
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUMETANIDE","activeIngredients":"BUMETANIDE","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUMETANIDE","activeIngredients":"BUMETANIDE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUMETANIDE","activeIngredients":"BUMETANIDE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/12\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-12
        )

)