Application 091041

Type: ANDA
Sponsor: SAGENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 0.2MG BASE/ML	No	No
002	OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 1MG BASE/ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091041-001	OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP		2013-11-12
A091041-002	OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP		2013-11-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091041-001	AP
A091041-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A091041-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091041-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091041-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091041-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091041-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091041-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091041-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091041-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091041-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091041-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091041-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091041-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091041-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091041-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091041-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091041-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091041-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091041-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091041-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091041-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091041-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091041-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091041-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091041-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091041-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091041-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091041-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091041-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091041-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091041-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091041-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091041-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091041-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091041-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091041-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091041-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091041-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091041-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091041-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091041-002	AP	1	`782e0a99824c…`

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 · 15 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	Name fallback generic name: OCTREOTIDE ACETATE
Octreotide Acetate	OCTREOTIDE ACETATE	GLENMARK PHARMACEUTICALS INC., USA	387d7f8d-9762-4f6b-99e1-bdc50b8a1633	2026-01-30	Warnings, Adverse reactions	Name fallback brand name: Octreotide Acetate generic name: OCTREOTIDE ACETATE
OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	Mylan Institutional LLC	e5c21813-4714-4f23-be8b-765bd58f63b3	2026-01-21	Warnings, Adverse reactions	Name fallback brand name: OCTREOTIDE ACETATE generic name: OCTREOTIDE ACETATE
Sandostatin LAR Depot	OCTREOTIDE ACETATE	Novartis Pharmaceuticals Corporation	d0b7fe9e-7000-4b79-ba3b-291ce92c14f9	2025-12-22	Warnings, Adverse reactions	Name fallback generic name: OCTREOTIDE ACETATE
OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	Hainan Shuangcheng Pharmaceuticals Co., Ltd.	ab9b0d3d-4dab-4c5b-9c23-3a14f8fcfcde	2025-06-25	Warnings, Adverse reactions	Name fallback brand name: OCTREOTIDE ACETATE generic name: OCTREOTIDE ACETATE
BYNFEZIA Pen	OCTREOTIDE ACETATE	Sun Pharmaceutical Industries, Inc.	20ed4e79-ad4c-426f-859d-83790c00439b	2025-02-21	Warnings, Adverse reactions	Name fallback generic name: OCTREOTIDE ACETATE
Octreotide Acetate	OCTREOTIDE ACETATE	Meitheal Pharmaceuticals, Inc.	01962c67-e551-47b6-a276-e1ae1860d2a4	2025-01-16	Warnings, Adverse reactions	Name fallback brand name: Octreotide Acetate generic name: OCTREOTIDE ACETATE
OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ffaf9462-cdd8-433b-8b03-464a35577fe9	2024-12-03	Warnings, Adverse reactions	Name fallback brand name: OCTREOTIDE ACETATE generic name: OCTREOTIDE ACETATE
Octreotide Acetate	OCTREOTIDE ACETATE	Teva Pharmaceuticals, Inc.	d9739ea6-74de-4a41-a806-6e827a23cedb	2024-07-30	Warnings, Adverse reactions	Name fallback brand name: Octreotide Acetate generic name: OCTREOTIDE ACETATE
Octreotide Acetate	OCTREOTIDE ACETATE	Gland Pharma Limited	884e4287-a4d8-4a6e-8d99-dbe5e88875b9	2024-07-29	Warnings, Adverse reactions	Name fallback brand name: Octreotide Acetate generic name: OCTREOTIDE ACETATE
Octreotide Acetate	OCTREOTIDE ACETATE	Gland Pharma Limited	2344ae7a-c2f0-433b-9133-1dcb16bb18a0	2024-07-25	Warnings, Adverse reactions	Name fallback brand name: Octreotide Acetate generic name: OCTREOTIDE ACETATE
Octreotide Acetate	OCTREOTIDE ACETATE	Mylan Institutional LLC	2d78d5d1-77b2-4da1-98d4-d9c36e743ce2	2024-07-15	Warnings, Adverse reactions	Name fallback brand name: Octreotide Acetate generic name: OCTREOTIDE ACETATE
Octreotide	OCTREOTIDE ACETATE	Fresenius Kabi USA, LLC	d6a9a800-889d-417f-b533-1913197d0022	2024-05-23	Warnings, Adverse reactions	Name fallback generic name: OCTREOTIDE ACETATE
Octreotide	OCTREOTIDE ACETATE	Fresenius Kabi USA, LLC	f278f0d8-4062-420a-97c3-3a8b88253a08	2024-05-07	Warnings, Adverse reactions	Name fallback generic name: OCTREOTIDE ACETATE
Octreotide Acetate	OCTREOTIDE ACETATE	Hikma Pharmaceuticals USA Inc.	9502860d-0261-4d69-a4be-827a5376d356	2024-03-01	Warnings, Adverse reactions	Name fallback brand name: Octreotide Acetate generic name: OCTREOTIDE ACETATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25021-454	Octreotide Acetate	octreotide acetate	Sagent Pharmaceuticals	ANDA	Current
25021-454	Octreotide Acetate	octreotide acetate	Sagent Pharmaceuticals	ANDA	Current
25021-454	Octreotide Acetate	octreotide acetate	Sagent Pharmaceuticals	ANDA	Current
25021-454	Octreotide Acetate	octreotide acetate	Sagent Pharmaceuticals	ANDA	Current
25021-455	Octreotide Acetate	octreotide acetate	Sagent Pharmaceuticals	ANDA	Current
25021-455	Octreotide Acetate	octreotide acetate	Sagent Pharmaceuticals	ANDA	Current
25021-455	Octreotide Acetate	octreotide acetate	Sagent Pharmaceuticals	ANDA	Current
25021-455	Octreotide Acetate	octreotide acetate	Sagent Pharmaceuticals	ANDA	Current
25021-466	Octreotide Acetate	octreotide acetate	Sagent Pharmaceuticals	ANDA	Current
25021-467	Octreotide Acetate	octreotide acetate	Sagent Pharmaceuticals	ANDA	Current