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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021008-001	SANDOSTATIN LAR	OCTREOTIDE ACETATE	EQ 10MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25
N021008-002	SANDOSTATIN LAR	OCTREOTIDE ACETATE	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25
N021008-003	SANDOSTATIN LAR	OCTREOTIDE ACETATE	EQ 30MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD, RS	1998-11-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N021008-001	AB
N021008-002	AB
N021008-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021008-001	SANDOSTATIN LAR	EQ 10MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021008-002	SANDOSTATIN LAR	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021008-003	SANDOSTATIN LAR	EQ 30MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD, RS	1998-11-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021008-001	SANDOSTATIN LAR	EQ 10MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021008-002	SANDOSTATIN LAR	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021008-003	SANDOSTATIN LAR	EQ 30MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD, RS	1998-11-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021008-001	SANDOSTATIN LAR	EQ 10MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021008-002	SANDOSTATIN LAR	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021008-003	SANDOSTATIN LAR	EQ 30MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD, RS	1998-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021008-001	SANDOSTATIN LAR	EQ 10MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021008-002	SANDOSTATIN LAR	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021008-003	SANDOSTATIN LAR	EQ 30MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD, RS	1998-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021008-001	SANDOSTATIN LAR	EQ 10MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021008-002	SANDOSTATIN LAR	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021008-003	SANDOSTATIN LAR	EQ 30MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD, RS	1998-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021008-001	SANDOSTATIN LAR	EQ 10MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021008-002	SANDOSTATIN LAR	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021008-003	SANDOSTATIN LAR	EQ 30MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD, RS	1998-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021008-001	SANDOSTATIN LAR	EQ 10MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021008-002	SANDOSTATIN LAR	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021008-003	SANDOSTATIN LAR	EQ 30MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD, RS	1998-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021008-001	SANDOSTATIN LAR	EQ 10MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021008-002	SANDOSTATIN LAR	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021008-003	SANDOSTATIN LAR	EQ 30MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD, RS	1998-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021008-001	SANDOSTATIN LAR	EQ 10MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021008-002	SANDOSTATIN LAR	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021008-003	SANDOSTATIN LAR	EQ 30MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD, RS	1998-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021008-001	SANDOSTATIN LAR	EQ 10MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021008-002	SANDOSTATIN LAR	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021008-003	SANDOSTATIN LAR	EQ 30MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD, RS	1998-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021008-001	SANDOSTATIN LAR	EQ 10MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021008-002	SANDOSTATIN LAR	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021008-003	SANDOSTATIN LAR	EQ 30MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD, RS	1998-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021008-001	SANDOSTATIN LAR	EQ 10MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021008-002	SANDOSTATIN LAR	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021008-003	SANDOSTATIN LAR	EQ 30MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD, RS	1998-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021008-001	SANDOSTATIN LAR	EQ 10MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021008-002	SANDOSTATIN LAR	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021008-003	SANDOSTATIN LAR	EQ 30MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD, RS	1998-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021008-001	SANDOSTATIN LAR	EQ 10MG BASE/VIAL	INJECTABLE / INJECTION	AB	RLD	1998-11-25	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021008-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021008-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021008-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021008-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021008-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021008-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021008-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021008-003	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021008-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021008-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021008-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021008-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021008-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021008-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021008-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021008-002	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021008-003	AP	1	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021008-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021008-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021008-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sandostatin LAR Depot	OCTREOTIDE ACETATE	Novartis Pharmaceuticals Corporation	d0b7fe9e-7000-4b79-ba3b-291ce92c14f9	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021008 application number: NDA021008 ndc (product): 0078-0811 ndc (product): 0078-0818 ndc (product): 0078-0825

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

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