NDA 021817

NOVARTIS

FDA Drug Application

Application #021817

Documents

• Letter: 2007-04-20
• Letter: 2008-12-31
• Letter: 2009-03-19
• Letter: 2011-01-27
• Letter: 2011-08-17
• Letter: 2013-04-24
• Letter: 2015-05-11
• Label: 2008-06-19
• Label: 2011-09-01
• Label: 2013-04-23
• Review: 2008-03-14
• Review: 2013-01-24
• Summary Review: 2008-07-17
• Letter: 2008-06-06
• Letter: 2009-06-10
• Letter: 2011-03-10
• Letter: 2011-09-01
• Letter: 2015-02-02
• Letter: 2016-04-15
• Label: 2007-04-20
• Label: 2009-01-06
• Label: 2009-04-21
• Label: 2009-06-10
• Label: 2011-03-11
• Label: 2011-01-26
• Label: 2015-02-19
• Label: 2015-04-19
• Label: 2016-04-15
• Label: 2017-07-10
• Letter: 2017-07-11
• Medication Guide: 2017-07-12
• Letter: 2020-04-30
• Label: 2020-04-30
• Medication Guide: 2020-04-30

Application Sponsors

NDA 021817

NOVARTIS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

EQ 5MG BASE/100ML

1

RECLAST

ZOLEDRONIC ACID

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2007-04-16	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	2008-12-19	UNKNOWN
EFFICACY; Efficacy	SUPPL	3	AP	2009-03-13	UNKNOWN
EFFICACY; Efficacy	SUPPL	4	AP	2009-05-29	UNKNOWN
LABELING; Labeling	SUPPL	6	AP	2011-03-08	UNKNOWN
REMS; REMS	SUPPL	9	AP	2011-01-25	N/A
LABELING; Labeling	SUPPL	12	AP	2011-08-31	UNKNOWN
REMS; REMS	SUPPL	13	AP	2011-08-15	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2013-07-23	PRIORITY
LABELING; Labeling	SUPPL	15	AP	2013-04-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2013-09-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2014-05-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2014-06-17	PRIORITY
LABELING; Labeling	SUPPL	20	AP	2015-01-30	STANDARD
LABELING; Labeling	SUPPL	21	AP	2015-04-16	STANDARD
LABELING; Labeling	SUPPL	22	AP	2016-04-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2016-05-24	PRIORITY
LABELING; Labeling	SUPPL	27	AP	2017-07-07	STANDARD
LABELING; Labeling	SUPPL	28	AP	2020-04-29	STANDARD

Submissions Property Types

SUPPL	1	Null	31
SUPPL	2	Null	6
SUPPL	3	Null	6
SUPPL	4	Null	6
SUPPL	6	Null	7
SUPPL	9	Null	6
SUPPL	12	Null	15
SUPPL	13	Null	6
SUPPL	14	Null	0
SUPPL	15	Null	15
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	15
SUPPL	21	Null	31
SUPPL	22	Null	6
SUPPL	23	Null	0
SUPPL	27	Null	15
SUPPL	28	Null	6

TE Codes

001

Prescription

AP

CDER Filings

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            [products] => []
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        )

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