ANDA 086890

WATSON LABS TEVA

FDA Drug Application

Application #086890

Application Sponsors

ANDA 086890

WATSON LABS TEVA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

500MG

0

DISULFIRAM

DISULFIRAM

FDA Submissions

	ORIG	1	AP	1981-03-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1982-05-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1985-08-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1985-08-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1985-08-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1988-10-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1988-10-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1990-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1991-05-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1991-01-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1992-05-13
LABELING; Labeling	SUPPL	22	AP	1998-04-14

Submissions Property Types

SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	0

CDER Filings

WATSON LABS TEVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86890
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DISULFIRAM","activeIngredients":"DISULFIRAM","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DISULFIRAM","submission":"DISULFIRAM","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)