ANDA 090427

NOSTRUM LABS INC

FDA Drug Application

Application #090427

Application Sponsors

ANDA 090427

NOSTRUM LABS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	500MG	0	NABUMETONE	NABUMETONE
002	TABLET;ORAL	750MG	0	NABUMETONE	NABUMETONE

FDA Submissions

	ORIG	1	AP	2011-12-30
LABELING; Labeling	SUPPL	2	AP	2021-04-28	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

NOSTRUM LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90427
            [companyName] => NOSTRUM LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NABUMETONE","activeIngredients":"NABUMETONE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NABUMETONE","activeIngredients":"NABUMETONE","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NABUMETONE","submission":"NABUMETONE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NABUMETONE","submission":"NABUMETONE","actionType":"750MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)