ANDA 083234

UPSHER SMITH LABS

FDA Drug Application

Application #083234

Application Sponsors

ANDA 083234

UPSHER SMITH LABS

Marketing Status

• Discontinued: 002

Application Products

002

TABLET;ORAL

500MG

0

GLUTETHIMIDE

GLUTETHIMIDE

FDA Submissions

	ORIG	1	AP	1976-10-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1982-06-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1982-06-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1982-06-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1982-06-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1982-06-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1983-01-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1982-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1984-01-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1984-01-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	1984-06-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1984-11-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1986-10-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	1987-01-15
LABELING; Labeling	SUPPL	52	AP	1991-08-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	2000-01-19

Submissions Property Types

SUPPL	30	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	0
SUPPL	48	Null	0
SUPPL	50	Null	0
SUPPL	51	Null	0
SUPPL	54	Null	0

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83234
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLUTETHIMIDE","activeIngredients":"GLUTETHIMIDE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GLUTETHIMIDE","submission":"GLUTETHIMIDE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)