NDA 020036

NOVARTIS

FDA Drug Application

Application #020036

Documents

• Letter: 2004-09-10
• Letter: 1998-09-22
• Letter: 1998-09-22
• Letter: 2002-07-12
• Letter: 2004-03-28
• Letter: 2005-02-03
• Letter: 2005-10-14
• Letter: 2005-11-18
• Letter: 2011-04-04
• Label: 2001-08-20
• Label: 2005-02-03
• Label: 2005-10-14
• Label: 2005-11-18
• Label: 2007-12-14
• Label: 2009-01-02
• Label: 2012-06-06
• Review: 2004-01-06
• Review: 2004-01-06
• Review: 2004-01-06
• Review: 2008-02-19
• Review: 2004-05-27
• Review: 2007-08-06
• Letter: 2003-12-02
• Letter: 2003-10-16
• Letter: 2001-08-20
• Letter: 2004-01-09
• Letter: 2008-01-09
• Letter: 2008-12-18
• Letter: 2012-06-07
• Other Important Information from FDA: 2008-01-07
• Label: 2003-12-02
• Label: 2003-04-30
• Label: 2011-04-11
• Review: 2004-01-06
• Review: 2004-01-06
• Review: 2004-01-06
• Review: 1998-09-22
• Review: 1998-09-22
• Review: 2009-01-12

Application Sponsors

NDA 020036

NOVARTIS

Marketing Status

• Discontinued: 001
• Discontinued: 003
• Discontinued: 004

Application Products

001	INJECTABLE;INJECTION	30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	AREDIA	PAMIDRONATE DISODIUM
003	INJECTABLE;INJECTION	60MG/VIAL	0	AREDIA	PAMIDRONATE DISODIUM
004	INJECTABLE;INJECTION	90MG/VIAL	0	AREDIA	PAMIDRONATE DISODIUM

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1991-10-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1993-05-06	PRIORITY
LABELING; Labeling	SUPPL	3	AP	1992-07-21	PRIORITY
EFFICACY; Efficacy	SUPPL	4	AP	1994-04-15	PRIORITY
LABELING; Labeling	SUPPL	5	AP	1993-06-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1995-04-17	PRIORITY
EFFICACY; Efficacy	SUPPL	7	AP	1994-09-21	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1994-12-08	PRIORITY
EFFICACY; Efficacy	SUPPL	9	AP	1995-09-01	PRIORITY
EFFICACY; Efficacy	SUPPL	11	AP	1996-07-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1998-10-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1998-09-10	PRIORITY
LABELING; Labeling	SUPPL	15	AP	1998-09-22	PRIORITY
LABELING; Labeling	SUPPL	16	AP	1998-09-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2000-04-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2000-03-31	PRIORITY
LABELING; Labeling	SUPPL	20	AP	2003-10-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2001-03-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2002-01-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2001-11-15	PRIORITY
EFFICACY; Efficacy	SUPPL	24	AP	2001-08-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2002-02-12	PRIORITY
EFFICACY; Efficacy	SUPPL	26	AP	2002-07-12	PRIORITY
LABELING; Labeling	SUPPL	28	AP	2004-01-09	PRIORITY
LABELING; Labeling	SUPPL	29	AP	2004-03-24	PRIORITY
LABELING; Labeling	SUPPL	30	AP	2005-02-02	PRIORITY
LABELING; Labeling	SUPPL	31	AP	2005-10-11	PRIORITY
LABELING; Labeling	SUPPL	32	AP	2005-11-16	PRIORITY
LABELING; Labeling	SUPPL	34	AP	2007-12-11	PRIORITY
LABELING; Labeling	SUPPL	35	AP	2008-12-12	PRIORITY
LABELING; Labeling	SUPPL	39	AP	2011-04-07	PRIORITY
LABELING; Labeling	SUPPL	41	AP	2012-05-31	PRIORITY

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	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	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	39	Null	0
SUPPL	41	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20036
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)