ANDA 080767

IMPAX LABS

FDA Drug Application

Application #080767

Application Sponsors

ANDA 080767

IMPAX LABS

Marketing Status

• Prescription: 002

Application Products

002

TABLET;ORAL

10MG

0

METHYLTESTOSTERONE

METHYLTESTOSTERONE

FDA Submissions

	ORIG	1	AP	1974-10-17
LABELING; Labeling	SUPPL	55	AP	1988-07-06
LABELING; Labeling	SUPPL	57	AP	1988-10-31
LABELING; Labeling	SUPPL	58	AP	1989-07-20
LABELING; Labeling	SUPPL	59	AP	1989-07-20
LABELING; Labeling	SUPPL	60	AP	1990-01-19
LABELING; Labeling	SUPPL	61	AP	1991-07-05
LABELING; Labeling	SUPPL	62	AP	1991-10-09
LABELING; Labeling	SUPPL	63	AP	1997-10-29
LABELING; Labeling	SUPPL	64	AP	2000-03-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	65	AP	2002-03-08
LABELING; Labeling	SUPPL	66	AP	2002-03-08
LABELING; Labeling	SUPPL	67	AP	2002-11-04
LABELING; Labeling	SUPPL	77	AP	2014-06-19	STANDARD
LABELING; Labeling	SUPPL	78	AP	2015-05-11	STANDARD
LABELING; Labeling	SUPPL	82	AP	2016-10-25	STANDARD

Submissions Property Types

SUPPL	65	Null	0
SUPPL	77	Null	7
SUPPL	78	Null	7
SUPPL	82	Null	15

TE Codes

002

Prescription

BP

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80767
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLTESTOSTERONE","activeIngredients":"METHYLTESTOSTERONE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHYLTESTOSTERONE","submission":"METHYLTESTOSTERONE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)