ANDA 070544

YAOPHARMA CO LTD

FDA Drug Application

Application #070544

Application Sponsors

ANDA 070544

YAOPHARMA CO LTD

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG;500MG

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	5	AP	1986-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1988-01-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1988-02-17
LABELING; Labeling	SUPPL	12	AP	1989-09-15
LABELING; Labeling	SUPPL	13	AP	1992-01-31
LABELING; Labeling	SUPPL	14	AP	1993-04-30
LABELING; Labeling	SUPPL	15	AP	1993-08-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1994-01-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1996-08-19
LABELING; Labeling	SUPPL	18	AP	1996-04-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1998-11-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1998-11-25
LABELING; Labeling	SUPPL	26	AP	2020-08-06	STANDARD
LABELING; Labeling	SUPPL	27	AP	2020-08-20	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	10	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	26	Null	15
SUPPL	27	Null	15

CDER Filings

YAOPHARMA CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70544
            [companyName] => YAOPHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLDOPA AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; METHYLDOPA","strength":"50MG;500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHYLDOPA AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; METHYLDOPA","actionType":"50MG;500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)