ANDA 073357

YAOPHARMA CO LTD

FDA Drug Application

Application #073357

Application Sponsors

ANDA 073357

YAOPHARMA CO LTD

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

EQ 5MG ANHYDROUS;50MG

0

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

FDA Submissions

	ORIG	1	AP	1991-11-27
LABELING; Labeling	SUPPL	2	AP	1993-11-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1996-08-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1996-08-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-06-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-12-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1998-12-01
LABELING; Labeling	SUPPL	8	AP	2020-08-06	STANDARD
LABELING; Labeling	SUPPL	9	AP	2020-08-20	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	15
SUPPL	9	Null	15

CDER Filings

YAOPHARMA CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 73357
            [companyName] => YAOPHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","activeIngredients":"AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE","strength":"EQ 5MG ANHYDROUS;50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","submission":"AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE","actionType":"EQ 5MG ANHYDROUS;50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)