ANDA 080159

IMPAX LABS

FDA Drug Application

Application #080159

Application Sponsors

ANDA 080159

IMPAX LABS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

0

PROPYLTHIOURACIL

PROPYLTHIOURACIL

FDA Submissions

	ORIG	1	AP	1973-08-10
LABELING; Labeling	SUPPL	32	AP	1989-12-14
LABELING; Labeling	SUPPL	33	AP	1989-05-02
LABELING; Labeling	SUPPL	34	AP	1991-01-11
LABELING; Labeling	SUPPL	35	AP	1991-01-11

Submissions Property Types

ORIG	1	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80159
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROPYLTHIOURACIL","activeIngredients":"PROPYLTHIOURACIL","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROPYLTHIOURACIL","submission":"PROPYLTHIOURACIL","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)