ANDA 080153

IMPAX LABS

FDA Drug Application

Application #080153

Application Sponsors

ANDA 080153

IMPAX LABS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

100MG

0

ISONIAZID

ISONIAZID

FDA Submissions

	ORIG	1	AP	1973-08-01
LABELING; Labeling	SUPPL	13	AP	1992-06-18

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80153
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISONIAZID","activeIngredients":"ISONIAZID","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISONIAZID","submission":"ISONIAZID","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)