Application 021008

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SANDOSTATIN LAR	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 10MG BASE/VIAL	Yes	No
002	SANDOSTATIN LAR	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 20MG BASE/VIAL	Yes	No
003	SANDOSTATIN LAR	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 30MG BASE/VIAL	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0647	Sandostatin LAR Depot	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0647	Sandostatin LAR Depot	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0648	Sandostatin LAR Depot	octreotide acetate	Novartis Pharmaceuticals	NDA	Current
0078-0811	Sandostatin LAR Depot	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0811	Sandostatin LAR Depot	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0811	Sandostatin LAR Depot	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0811	Sandostatin LAR Depot	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0811	Sandostatin LAR Depot	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0811	Sandostatin LAR Depot	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0818	Sandostatin LAR Depot	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0818	Sandostatin LAR Depot	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0818	Sandostatin LAR Depot	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0818	Sandostatin LAR Depot	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0818	Sandostatin LAR Depot	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0818	Sandostatin LAR Depot	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0825	Sandostatin LAR Depot	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0825	Sandostatin LAR Depot	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0825	Sandostatin LAR Depot	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0825	Sandostatin LAR Depot	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0825	Sandostatin LAR Depot	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0825	Sandostatin LAR Depot	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79086	SUPPL	2024-07-15
79062	SUPPL	2024-07-15
77196	SUPPL	2024-01-25
77198	SUPPL	2024-01-09
73996	SUPPL	2023-04-14
73995	SUPPL	2023-04-14
66959	SUPPL	2021-04-01
66927	SUPPL	2021-03-31
58319	SUPPL	2019-04-12
58313	SUPPL	2019-04-12
57012	SUPPL	2019-03-27
57084	SUPPL	2018-12-31
35876	SUPPL	2016-07-25
41872	SUPPL	2015-09-23
14155	SUPPL	2014-07-22
35875	SUPPL	2014-06-02
26475	SUPPL	2014-05-20
4028	SUPPL	2011-10-03
35874	SUPPL	2011-09-30
26474	SUPPL	2010-02-05
35873	SUPPL	2010-02-04
35872	SUPPL	2008-03-05
26473	SUPPL	2008-03-05
35871	SUPPL	2006-05-16
26472	SUPPL	2006-05-16
26471	SUPPL	2006-05-16
14154	SUPPL	2006-05-16
4027	SUPPL	2004-10-18
35870	SUPPL	2004-05-03
26470	SUPPL	2004-04-29
26469	SUPPL	2003-12-23
26468	ORIG	1998-11-25
21352	ORIG	1998-11-25
14153	ORIG	1998-11-25
63719	SUPPL	1900-01-01
63718	SUPPL	1900-01-01
63717	SUPPL	1900-01-01
63716	SUPPL	1900-01-01

Application 021008

Related Records#

Application Products#

NDC Listings For This Application#

Documents#