ANDA 074615

YAOPHARMA CO LTD

FDA Drug Application

Application #074615

Application Sponsors

ANDA 074615

YAOPHARMA CO LTD

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

600MG

0

GEMFIBROZIL

GEMFIBROZIL

FDA Submissions

	ORIG	1	AP	1995-09-29
LABELING; Labeling	SUPPL	2	AP	1996-02-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1996-01-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1997-12-12
LABELING; Labeling	SUPPL	7	AP	2009-04-08

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0

CDER Filings

YAOPHARMA CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74615
            [companyName] => YAOPHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"GEMFIBROZIL","activeIngredients":"GEMFIBROZIL","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GEMFIBROZIL","submission":"GEMFIBROZIL","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)