ANDA 084810

NOVARTIS

FDA Drug Application

Application #084810

Application Sponsors

ANDA 084810

NOVARTIS

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

50MG;50MG

0

APRESAZIDE

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

FDA Submissions

	ORIG	1	AP	1976-05-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1982-03-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1982-03-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1982-03-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1988-11-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1988-11-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1988-11-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1988-11-22
LABELING; Labeling	SUPPL	19	AP	1989-03-06
LABELING; Labeling	SUPPL	23	AP	1991-06-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1992-06-18
LABELING; Labeling	SUPPL	25	AP	1992-02-21
LABELING; Labeling	SUPPL	26	AP	1992-11-04
LABELING; Labeling	SUPPL	27	AP	1993-04-07
LABELING; Labeling	SUPPL	28	AP	1996-01-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1996-12-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1998-11-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1999-07-20

Submissions Property Types

SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84810
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)