ANDA 084310

IMPAX LABS

FDA Drug Application

Application #084310

Application Sponsors

ANDA 084310

IMPAX LABS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

25MG

0

METHYLTESTOSTERONE

METHYLTESTOSTERONE

FDA Submissions

	ORIG	1	AP	1974-06-21
LABELING; Labeling	SUPPL	62	AP	1988-07-06
LABELING; Labeling	SUPPL	63	AP	1988-10-31
LABELING; Labeling	SUPPL	64	AP	1989-06-22
LABELING; Labeling	SUPPL	65	AP	1989-10-23
LABELING; Labeling	SUPPL	67	AP	1990-01-19
LABELING; Labeling	SUPPL	68	AP	1991-07-05
LABELING; Labeling	SUPPL	69	AP	1991-07-05
LABELING; Labeling	SUPPL	70	AP	1991-10-09
LABELING; Labeling	SUPPL	71	AP	1997-10-29
LABELING; Labeling	SUPPL	72	AP	2000-03-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	73	AP	1999-08-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	74	AP	2002-05-07
LABELING; Labeling	SUPPL	75	AP	2002-05-07
LABELING; Labeling	SUPPL	76	AP	2002-11-04
LABELING; Labeling	SUPPL	77	AP	2014-06-19	STANDARD
LABELING; Labeling	SUPPL	78	AP	2015-05-11	STANDARD

Submissions Property Types

SUPPL	73	Null	0
SUPPL	74	Null	0
SUPPL	77	Null	7
SUPPL	78	Null	7

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84310
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLTESTOSTERONE","activeIngredients":"METHYLTESTOSTERONE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHYLTESTOSTERONE","submission":"METHYLTESTOSTERONE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)