ANDA 084912

YAOPHARMA CO LTD

FDA Drug Application

Application #084912

Application Sponsors

ANDA 084912

YAOPHARMA CO LTD

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

0

HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE

FDA Submissions

	ORIG	1	AP	1976-12-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1982-07-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1982-07-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1982-07-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1982-07-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1982-08-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1983-08-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	1983-08-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	1985-04-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1985-04-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	1987-06-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	1987-06-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	1987-06-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	56	AP	1987-06-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	57	AP	1990-08-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	58	AP	1990-08-21
LABELING; Labeling	SUPPL	59	AP	1988-05-27
LABELING; Labeling	SUPPL	60	AP	1989-08-23
LABELING; Labeling	SUPPL	61	AP	1989-11-21
LABELING; Labeling	SUPPL	62	AP	1989-11-09
LABELING; Labeling	SUPPL	63	AP	1992-08-11
LABELING; Labeling	SUPPL	64	AP	1994-03-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	65	AP	1994-01-24
LABELING; Labeling	SUPPL	66	AP	1995-07-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	67	AP	1998-01-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	68	AP	1998-12-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	69	AP	1998-12-01
LABELING; Labeling	SUPPL	70	AP	2020-08-06	STANDARD
LABELING; Labeling	SUPPL	71	AP	2020-08-20	STANDARD

Submissions Property Types

SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	39	Null	0
SUPPL	41	Null	0
SUPPL	43	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	0
SUPPL	49	Null	0
SUPPL	50	Null	0
SUPPL	53	Null	0
SUPPL	54	Null	0
SUPPL	55	Null	0
SUPPL	56	Null	0
SUPPL	57	Null	0
SUPPL	58	Null	0
SUPPL	65	Null	0
SUPPL	67	Null	0
SUPPL	68	Null	0
SUPPL	69	Null	0
SUPPL	70	Null	15
SUPPL	71	Null	7

CDER Filings

YAOPHARMA CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84912
            [companyName] => YAOPHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)