ANDA 084735

NOVARTIS

FDA Drug Application

Application #084735

Application Sponsors

ANDA 084735

NOVARTIS

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

25MG;25MG

0

APRESAZIDE

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

FDA Submissions

	ORIG	1	AP	1976-05-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1982-03-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1982-03-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1982-03-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1983-09-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1988-11-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1988-11-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1988-11-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1988-11-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1992-04-30
LABELING; Labeling	SUPPL	23	AP	1989-03-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1989-02-09
LABELING; Labeling	SUPPL	26	AP	1988-11-03
LABELING; Labeling	SUPPL	29	AP	1991-06-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1992-06-18
LABELING; Labeling	SUPPL	31	AP	1992-02-21
LABELING; Labeling	SUPPL	32	AP	1992-11-04
LABELING; Labeling	SUPPL	33	AP	1993-04-07
LABELING; Labeling	SUPPL	34	AP	1996-01-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1996-12-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1998-11-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1999-07-20

Submissions Property Types

SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0
SUPPL	30	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84735
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)