ANDA 088570

SUN PHARM INDUSTRIES

FDA Drug Application

Application #088570

Application Sponsors

ANDA 088570

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

25MG;15MG;0.1MG

0

RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE

FDA Submissions

	ORIG	1	AP	1984-04-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1987-10-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-09-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1986-09-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1987-04-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1987-12-08
LABELING; Labeling	SUPPL	13	AP	1989-06-16
LABELING; Labeling	SUPPL	15	AP	1991-11-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1992-04-03
LABELING; Labeling	SUPPL	17	AP	1992-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1994-10-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1994-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1998-12-01
LABELING; Labeling	SUPPL	23	AP	2020-08-28	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	1
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	15

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88570
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE","strength":"25MG;15MG;0.1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","submission":"HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE","actionType":"25MG;15MG;0.1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)