ANDA 084340

IMPAX LABS

FDA Drug Application

Application #084340

Application Sponsors

ANDA 084340

IMPAX LABS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

4MG

0

TRIAMCINOLONE

TRIAMCINOLONE

FDA Submissions

	ORIG	1	AP	1975-04-22
LABELING; Labeling	SUPPL	37	AP	1989-05-19
LABELING; Labeling	SUPPL	38	AP	1990-05-25
LABELING; Labeling	SUPPL	39	AP	1992-03-13
LABELING; Labeling	SUPPL	41	AP	1992-03-13

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84340
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIAMCINOLONE","activeIngredients":"TRIAMCINOLONE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRIAMCINOLONE","submission":"TRIAMCINOLONE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)