INVAGEN PHARMS FDA Approval ANDA 078671

ANDA 078671

INVAGEN PHARMS

FDA Drug Application

Application #078671

Application Sponsors

ANDA 078671INVAGEN PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL500MG0NABUMETONENABUMETONE
002TABLET;ORAL750MG0NABUMETONENABUMETONE

FDA Submissions

ORIG1AP2008-03-07
LABELING; LabelingSUPPL10AP2016-05-09STANDARD
LABELING; LabelingSUPPL20AP2021-04-28STANDARD

Submissions Property Types

ORIG1Null1
SUPPL10Null7
SUPPL20Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

INVAGEN PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78671
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"NABUMETONE","activeIngredients":"NABUMETONE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NABUMETONE","activeIngredients":"NABUMETONE","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NABUMETONE","submission":"NABUMETONE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NABUMETONE","submission":"NABUMETONE","actionType":"750MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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