ANDA 074363

YAOPHARMA CO LTD

FDA Drug Application

Application #074363

Application Sponsors

ANDA 074363

YAOPHARMA CO LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	TABLET;ORAL	12.5MG	0	CAPTOPRIL	CAPTOPRIL
002	TABLET;ORAL	25MG	0	CAPTOPRIL	CAPTOPRIL
003	TABLET;ORAL	50MG	0	CAPTOPRIL	CAPTOPRIL
004	TABLET;ORAL	100MG	0	CAPTOPRIL	CAPTOPRIL

FDA Submissions

	ORIG	1	AP	1995-11-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1997-06-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1997-08-11
LABELING; Labeling	SUPPL	4	AP	1997-11-05
LABELING; Labeling	SUPPL	5	AP	1998-02-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1999-04-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-05-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-03-25
LABELING; Labeling	SUPPL	9	AP	2004-05-14
LABELING; Labeling	SUPPL	12	AP	2008-10-29
LABELING; Labeling	SUPPL	13	AP	2008-12-05
LABELING; Labeling	SUPPL	14	AP	2009-03-27

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0

CDER Filings

YAOPHARMA CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74363
            [companyName] => YAOPHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CAPTOPRIL","activeIngredients":"CAPTOPRIL","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CAPTOPRIL","activeIngredients":"CAPTOPRIL","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CAPTOPRIL","activeIngredients":"CAPTOPRIL","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CAPTOPRIL","activeIngredients":"CAPTOPRIL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CAPTOPRIL","submission":"CAPTOPRIL","actionType":"12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CAPTOPRIL","submission":"CAPTOPRIL","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CAPTOPRIL","submission":"CAPTOPRIL","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CAPTOPRIL","submission":"CAPTOPRIL","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)