Application 090986

Type: ANDA
Sponsor: WOCKHARDT USA

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 44.

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
A090986-001	OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION			2011-05-11
A090986-002	OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION			2011-05-11

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090986-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090986-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090986-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090986-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090986-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090986-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090986-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090986-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090986-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090986-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090986-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090986-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090986-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090986-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090986-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090986-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090986-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090986-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090986-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090986-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090986-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090986-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090986-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090986-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090986-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A090986-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090986-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090986-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090986-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090986-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090986-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090986-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090986-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090986-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090986-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A090986-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090986-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A090986-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090986-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090986-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	2011-05-11	`3a93d1ddd44b…`

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

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55648-632	Octreotide acetate	Octreotide acetate	Wockhardt Limited	ANDA	Current
55648-634	Octreotide acetate	Octreotide acetate	Wockhardt Limited	ANDA	Current
64679-632	Octreotide acetate	Octreotide acetate	Wockhardt USA LLC.	ANDA	Current
64679-634	Octreotide acetate	Octreotide acetate	Wockhardt USA LLC.	ANDA	Current