ANDA 070289

YAOPHARMA CO LTD

FDA Drug Application

Application #070289

Application Sponsors

ANDA 070289

YAOPHARMA CO LTD

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

250MG

0

TOLAZAMIDE

TOLAZAMIDE

FDA Submissions

	ORIG	1	AP	1986-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1987-12-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1987-12-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1987-12-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1988-11-08
LABELING; Labeling	SUPPL	7	AP	1989-05-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1990-03-14
LABELING; Labeling	SUPPL	9	AP	1992-07-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1995-10-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1996-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2001-05-09

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0

CDER Filings

YAOPHARMA CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70289
            [companyName] => YAOPHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOLAZAMIDE","activeIngredients":"TOLAZAMIDE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TOLAZAMIDE","submission":"TOLAZAMIDE","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)