ANDA 070182

YAOPHARMA CO LTD

FDA Drug Application

Application #070182

Application Sponsors

ANDA 070182

YAOPHARMA CO LTD

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

15MG;250MG

0

METHYLDOPA AND HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE; METHYLDOPA

FDA Submissions

	ORIG	1	AP	1986-01-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-12-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1986-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1988-01-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1991-02-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1991-02-23
LABELING; Labeling	SUPPL	14	AP	1989-09-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1989-09-11
LABELING; Labeling	SUPPL	16	AP	1992-01-31
LABELING; Labeling	SUPPL	17	AP	1993-04-30
LABELING; Labeling	SUPPL	18	AP	1993-08-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1994-01-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1996-08-19
LABELING; Labeling	SUPPL	21	AP	1996-04-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1998-11-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1998-11-25
LABELING; Labeling	SUPPL	29	AP	2020-08-06	STANDARD
LABELING; Labeling	SUPPL	30	AP	2020-08-20	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	29	Null	7
SUPPL	30	Null	15

CDER Filings

YAOPHARMA CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70182
            [companyName] => YAOPHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLDOPA AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; METHYLDOPA","strength":"15MG;250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHYLDOPA AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; METHYLDOPA","actionType":"15MG;250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)