ANDA 075818

YAOPHARMA CO LTD

FDA Drug Application

Application #075818

Documents

• Letter: 2003-04-15
• Letter: 2004-06-04

Application Sponsors

ANDA 075818

YAOPHARMA CO LTD

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

125MG

0

FLUTAMIDE

FLUTAMIDE

FDA Submissions

	ORIG	1	AP	2001-09-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-09-20
LABELING; Labeling	SUPPL	6	AP	2012-04-25

Submissions Property Types

SUPPL	2	Null	0
SUPPL	6	Null	15

CDER Filings

YAOPHARMA CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75818
            [companyName] => YAOPHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUTAMIDE","activeIngredients":"FLUTAMIDE","strength":"125MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUTAMIDE","submission":"FLUTAMIDE","actionType":"125MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)