NDA 021990

NOVARTIS

FDA Drug Application

Application #021990

Documents

• Letter: 2007-01-08
• Letter: 2007-07-05
• Letter: 2008-07-25
• Letter: 2010-04-05
• Letter: 2011-11-02
• Letter: 2012-01-20
• Letter: 2014-03-19
• Letter: 2014-09-25
• Letter: 2015-07-30
• Label: 2011-06-07
• Label: 2011-12-13
• Label: 2012-12-10
• Label: 2014-09-26
• Label: 2015-07-30
• Letter: 2011-06-03
• Letter: 2011-12-14
• Letter: 2012-10-02
• Letter: 2012-11-29
• Letter: 2014-03-19
• Label: 2007-06-25
• Label: 2008-07-24
• Label: 2010-04-04
• Label: 2011-10-31
• Label: 2012-01-30
• Label: 2012-10-01
• Label: 2014-03-19
• Review: 2008-10-03
• Review: 2017-05-17
• Letter: 2019-06-13
• Label: 2019-06-13
• Letter: 2021-04-08
• Label: 2023-01-27

Application Sponsors

NDA 021990

NOVARTIS

Marketing Status

• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

002	TABLET;ORAL	EQ 5MG BASE;160MG	1	EXFORGE	AMLODIPINE BESYLATE; VALSARTAN
003	TABLET;ORAL	EQ 10MG BASE;160MG	1	EXFORGE	AMLODIPINE BESYLATE; VALSARTAN
004	TABLET;ORAL	EQ 5MG BASE;320MG	1	EXFORGE	AMLODIPINE BESYLATE; VALSARTAN
005	TABLET;ORAL	EQ 10MG BASE;320MG	1	EXFORGE	AMLODIPINE BESYLATE; VALSARTAN

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2007-06-20	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2008-07-23	STANDARD
LABELING; Labeling	SUPPL	7	AP	2010-03-30	STANDARD
LABELING; Labeling	SUPPL	13	AP	2011-05-31	UNKNOWN
LABELING; Labeling	SUPPL	14	AP	2011-12-07	UNKNOWN
LABELING; Labeling	SUPPL	16	AP	2011-10-31	UNKNOWN
LABELING; Labeling	SUPPL	17	AP	2012-01-18	UNKNOWN
LABELING; Labeling	SUPPL	18	AP	2012-09-28	UNKNOWN
LABELING; Labeling	SUPPL	19	AP	2012-11-28	STANDARD
LABELING; Labeling	SUPPL	20	AP	2014-03-17	STANDARD
LABELING; Labeling	SUPPL	21	AP	2014-03-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2014-06-09	STANDARD
LABELING; Labeling	SUPPL	24	AP	2014-09-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2015-05-22	STANDARD
LABELING; Labeling	SUPPL	26	AP	2015-07-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2015-12-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2016-02-12	STANDARD
LABELING; Labeling	SUPPL	33	AP	2019-06-12	STANDARD
LABELING; Labeling	SUPPL	41	AP	2021-04-07	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	7	Null	7
SUPPL	13	Null	6
SUPPL	14	Null	6
SUPPL	16	Null	6
SUPPL	17	Null	6
SUPPL	18	Null	6
SUPPL	19	Null	7
SUPPL	20	Null	7
SUPPL	21	Null	15
SUPPL	22	Null	0
SUPPL	24	Null	7
SUPPL	25	Null	0
SUPPL	26	Null	15
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	33	Null	7
SUPPL	41	Null	15

TE Codes

002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21990
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)