ANDA 084811

NOVARTIS

FDA Drug Application

Application #084811

Application Sponsors

ANDA 084811

NOVARTIS

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

100MG;50MG

0

APRESAZIDE

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

FDA Submissions

	ORIG	1	AP	1976-05-26
LABELING; Labeling	SUPPL	19	AP	1989-03-06
LABELING; Labeling	SUPPL	23	AP	1991-06-20
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

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84811
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)