ANDA 070543

YAOPHARMA CO LTD

FDA Drug Application

Application #070543

Application Sponsors

ANDA 070543

YAOPHARMA CO LTD

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

30MG;500MG

0

METHYLDOPA AND HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE; METHYLDOPA

FDA Submissions

	ORIG	1	AP	1986-01-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1988-01-29
LABELING; Labeling	SUPPL	10	AP	1989-09-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1989-12-12
LABELING; Labeling	SUPPL	12	AP	1992-01-31
LABELING; Labeling	SUPPL	13	AP	1993-04-30
LABELING; Labeling	SUPPL	14	AP	1993-08-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1994-01-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1996-08-19
LABELING; Labeling	SUPPL	17	AP	1996-04-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1998-11-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1998-11-25
LABELING; Labeling	SUPPL	25	AP	2020-08-06	STANDARD
LABELING; Labeling	SUPPL	26	AP	2020-08-20	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	11	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	25	Null	15
SUPPL	26	Null	15

CDER Filings

YAOPHARMA CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70543
            [companyName] => YAOPHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLDOPA AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; METHYLDOPA","strength":"30MG;500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHYLDOPA AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; METHYLDOPA","actionType":"30MG;500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)