ANDA 209916

UPSHER SMITH LABS

FDA Drug Application

Application #209916

Application Sponsors

ANDA 209916

UPSHER SMITH LABS

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

2018-01-23

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209916
            [companyName] => UPSHER SMITH LABS
            [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":"01\/23\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/24\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-04-24
        )

)