Application 019667

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SANDOSTATIN	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 0.05MG BASE/ML	Yes	Yes
002	SANDOSTATIN	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 0.1MG BASE/ML	Yes	Yes
003	SANDOSTATIN	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 0.5MG BASE/ML	Yes	Yes
004	SANDOSTATIN	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 0.2MG BASE/ML	Yes	Yes
005	SANDOSTATIN	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 1MG BASE/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019667-001	SANDOSTATIN	OCTREOTIDE ACETATE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21
N019667-002	SANDOSTATIN	OCTREOTIDE ACETATE	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21
N019667-003	SANDOSTATIN	OCTREOTIDE ACETATE	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21
N019667-004	SANDOSTATIN	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-06-12
N019667-005	SANDOSTATIN	OCTREOTIDE ACETATE	EQ 1MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019667-001	AP
N019667-002	AP
N019667-003	AP

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 6 · 205 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
2026-02-19 14:30 UTC	2026-02	N019667-001	SANDOSTATIN	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019667-002	SANDOSTATIN	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019667-003	SANDOSTATIN	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019667-004	SANDOSTATIN	EQ 0.2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019667-005	SANDOSTATIN	EQ 1MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019667-001	SANDOSTATIN	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019667-002	SANDOSTATIN	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019667-003	SANDOSTATIN	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019667-004	SANDOSTATIN	EQ 0.2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019667-005	SANDOSTATIN	EQ 1MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019667-001	SANDOSTATIN	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019667-002	SANDOSTATIN	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019667-003	SANDOSTATIN	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019667-004	SANDOSTATIN	EQ 0.2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019667-005	SANDOSTATIN	EQ 1MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019667-001	SANDOSTATIN	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019667-002	SANDOSTATIN	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019667-003	SANDOSTATIN	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019667-004	SANDOSTATIN	EQ 0.2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019667-005	SANDOSTATIN	EQ 1MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019667-001	SANDOSTATIN	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019667-002	SANDOSTATIN	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019667-003	SANDOSTATIN	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019667-004	SANDOSTATIN	EQ 0.2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019667-005	SANDOSTATIN	EQ 1MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019667-001	SANDOSTATIN	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019667-002	SANDOSTATIN	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019667-003	SANDOSTATIN	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019667-004	SANDOSTATIN	EQ 0.2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019667-005	SANDOSTATIN	EQ 1MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019667-001	SANDOSTATIN	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019667-002	SANDOSTATIN	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019667-003	SANDOSTATIN	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019667-004	SANDOSTATIN	EQ 0.2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019667-005	SANDOSTATIN	EQ 1MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019667-001	SANDOSTATIN	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019667-002	SANDOSTATIN	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019667-003	SANDOSTATIN	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019667-004	SANDOSTATIN	EQ 0.2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019667-005	SANDOSTATIN	EQ 1MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-06-12	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 131 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019667-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019667-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019667-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019667-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019667-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019667-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019667-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019667-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019667-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019667-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019667-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019667-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019667-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019667-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019667-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019667-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019667-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019667-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019667-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019667-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019667-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019667-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019667-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019667-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019667-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019667-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019667-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019667-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019667-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019667-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019667-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019667-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019667-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019667-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019667-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019667-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019667-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019667-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019667-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019667-001	AP	1	`8072bd15b7f6…`

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	OCTREOTIDE ACETATE	Novartis Pharmaceuticals Corporation	4e2c9856-1836-49f0-9472-4dbeeb408f39	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019667 application number: NDA019667 ndc (product): 0078-0180 ndc (product): 0078-0182 ndc (product): 0078-0181

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0180	Sandostatin	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0180	Sandostatin	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0180	Sandostatin	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0180	Sandostatin	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0180	Sandostatin	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0180	Sandostatin	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0181	Sandostatin	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0181	Sandostatin	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0181	Sandostatin	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0181	Sandostatin	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0181	Sandostatin	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0181	Sandostatin	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0182	Sandostatin	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0182	Sandostatin	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0182	Sandostatin	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0182	Sandostatin	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0182	Sandostatin	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0182	Sandostatin	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0183	Sandostatin	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0183	Sandostatin	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0184	Sandostatin	octreotide acetate	Novartis Pharmaceuticals Corporation	NDA	Current
0781-3164	Octreotide Acetate	Octreotide Acetate	Sandoz Inc	NDA	Current
0781-3165	Octreotide Acetate	Octreotide Acetate	Sandoz Inc	NDA	Current
0781-3166	Octreotide Acetate	Octreotide Acetate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-3167	Octreotide Acetate	Octreotide Acetate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-3168	Octreotide Acetate	Octreotide Acetate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79085	SUPPL	2024-07-15
79060	SUPPL	2024-07-15
76389	SUPPL	2023-11-06
76376	SUPPL	2023-11-06
72272	SUPPL	2022-10-07
72246	SUPPL	2022-10-05
69537	SUPPL	2021-12-13
69069	SUPPL	2021-10-22
67657	SUPPL	2021-06-02
67597	SUPPL	2021-05-26
58317	SUPPL	2019-04-12
58314	SUPPL	2019-04-12
11614	SUPPL	2015-03-12
17537	SUPPL	2015-02-24
1479	SUPPL	2014-02-11
33849	SUPPL	2012-03-27
17536	SUPPL	2012-03-27
1478	SUPPL	2010-02-05
33848	SUPPL	2010-02-04
11613	SUPPL	2008-08-29
1477	SUPPL	2008-08-28
33847	SUPPL	2005-09-08
1476	SUPPL	2005-09-08
17535	SUPPL	2003-02-10
11612	SUPPL	2003-01-17
1475	SUPPL	2003-01-17
17534	SUPPL	2002-07-24
1474	SUPPL	2002-07-24
40962	SUPPL	1999-02-19