ANDA 086574

YAOPHARMA CO LTD

FDA Drug Application

Application #086574

Application Sponsors

ANDA 086574

YAOPHARMA CO LTD

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

500MG

0

TOLBUTAMIDE

TOLBUTAMIDE

FDA Submissions

	ORIG	1	AP	1980-06-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1982-04-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1982-04-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1982-04-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1982-04-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1983-04-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1985-01-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1986-02-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1986-12-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1986-12-17
LABELING; Labeling	SUPPL	22	AP	1991-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1999-12-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2001-05-09

Submissions Property Types

SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0

CDER Filings

YAOPHARMA CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86574
            [companyName] => YAOPHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOLBUTAMIDE","activeIngredients":"TOLBUTAMIDE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TOLBUTAMIDE","submission":"TOLBUTAMIDE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)