ANDA 084287

IMPAX LABS

FDA Drug Application

Application #084287

Application Sponsors

ANDA 084287

IMPAX LABS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;BUCCAL, SUBLINGUAL

10MG

0

METHYLTESTOSTERONE

METHYLTESTOSTERONE

FDA Submissions

	ORIG	1	AP	1974-07-16
LABELING; Labeling	SUPPL	58	AP	1988-07-06
LABELING; Labeling	SUPPL	59	AP	1988-10-31
LABELING; Labeling	SUPPL	60	AP	1989-05-11
LABELING; Labeling	SUPPL	61	AP	1989-07-20
LABELING; Labeling	SUPPL	62	AP	1989-11-28
LABELING; Labeling	SUPPL	63	AP	1990-01-19
LABELING; Labeling	SUPPL	64	AP	1991-07-05
LABELING; Labeling	SUPPL	65	AP	1991-10-09
LABELING; Labeling	SUPPL	66	AP	1997-10-29

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84287
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLTESTOSTERONE","activeIngredients":"METHYLTESTOSTERONE","strength":"10MG","dosageForm":"TABLET;BUCCAL, SUBLINGUAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHYLTESTOSTERONE","submission":"METHYLTESTOSTERONE","actionType":"10MG","submissionClassification":"TABLET;BUCCAL, SUBLINGUAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)