Application 021817

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RECLAST	ZOLEDRONIC ACID	INJECTABLE;INTRAVENOUS	EQ 5MG BASE/100ML	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0435	Reclast	zoledronic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0435	Reclast	zoledronic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0435	Reclast	zoledronic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0435	Reclast	zoledronic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0435	Reclast	zoledronic acid	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84929	SUPPL	2026-02-05
84926	SUPPL	2026-02-05
84915	SUPPL	2026-02-05
62774	SUPPL	2020-04-30
62773	SUPPL	2020-04-30
62748	SUPPL	2020-04-30
48959	SUPPL	2017-07-12
48946	SUPPL	2017-07-11
48936	SUPPL	2017-07-10
37706	SUPPL	2016-04-15
28652	SUPPL	2016-04-15
6250	SUPPL	2015-05-11
37705	SUPPL	2015-04-19
37704	SUPPL	2015-02-19
28651	SUPPL	2015-02-02
6249	SUPPL	2013-04-24
16419	SUPPL	2013-04-23
21829	SUPPL	2013-01-24
28650	SUPPL	2011-09-01
16418	SUPPL	2011-09-01
6248	SUPPL	2011-08-17
37702	SUPPL	2011-03-11
28649	SUPPL	2011-03-10
6247	SUPPL	2011-01-27
37703	SUPPL	2011-01-26
37701	SUPPL	2009-06-10
28648	SUPPL	2009-06-10
37700	SUPPL	2009-04-21
6246	SUPPL	2009-03-19
37699	SUPPL	2009-01-06
6245	SUPPL	2008-12-31
24219	SUPPL	2008-07-17
16417	SUPPL	2008-06-19
28647	SUPPL	2008-06-06
21828	ORIG	2008-03-14
37698	ORIG	2007-04-20
6244	ORIG	2007-04-20