Application 011707

Type: NDA
Sponsor: ENDO PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OPANA	OXYMORPHONE HYDROCHLORIDE	INJECTABLE;INJECTION	1.5MG/ML	No	No
002	OPANA	OXYMORPHONE HYDROCHLORIDE	INJECTABLE;INJECTION	1MG/ML	Yes	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
N011707-001	OPANA	OXYMORPHONE HYDROCHLORIDE	1.5MG/ML	INJECTABLE / INJECTION		Approved before 1982
N011707-002	OPANA	OXYMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982

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	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N011707-001	OPANA	1.5MG/ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N011707-002	OPANA	1MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N011707-001	OPANA	1.5MG/ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N011707-002	OPANA	1MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N011707-001	OPANA	1.5MG/ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N011707-002	OPANA	1MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N011707-001	OPANA	1.5MG/ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N011707-002	OPANA	1MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N011707-001	OPANA	1.5MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N011707-002	OPANA	1MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N011707-001	OPANA	1.5MG/ML	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N011707-002	OPANA	1MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N011707-001	OPANA	1.5MG/ML	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N011707-002	OPANA	1MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N011707-001	OPANA	1.5MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N011707-002	OPANA	1MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N011707-001	OPANA	1.5MG/ML	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N011707-002	OPANA	1MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N011707-001	OPANA	1.5MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N011707-002	OPANA	1MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N011707-001	OPANA	1.5MG/ML	INJECTABLE / INJECTION	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N011707-002	OPANA	1MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N011707-001	OPANA	1.5MG/ML	INJECTABLE / INJECTION	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N011707-002	OPANA	1MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N011707-001	OPANA	1.5MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N011707-002	OPANA	1MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N011707-001	OPANA	1.5MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N011707-002	OPANA	1MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N011707-001	OPANA	1.5MG/ML	INJECTABLE / INJECTION	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N011707-002	OPANA	1MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N011707-001	OPANA	1.5MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N011707-002	OPANA	1MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N011707-001	OPANA	1.5MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N011707-002	OPANA	1MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N011707-001	OPANA	1.5MG/ML	INJECTABLE / INJECTION	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N011707-002	OPANA	1MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N011707-001	OPANA	1.5MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N011707-002	OPANA	1MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N011707-001	OPANA	1.5MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N011707-002	OPANA	1MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxymorphone Hydrochloride	OXYMORPHONE HYDROCHLORIDE	Aurolife Pharma, LLC	22c7652a-aa16-4fa8-89d9-517e69059068	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYMORPHONE HYDROCHLORIDE
Oxymorphone Hydrochloride	OXYMORPHONE HYDROCHLORIDE	KVK-Tech, Inc.	dcb5b5d2-7d0a-497a-8f1e-3b96fd43320b	2026-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYMORPHONE HYDROCHLORIDE
Oxymorphone hydrochloride	OXYMORPHONE HYDROCHLORIDE	Amneal Pharmaceuticals LLC	3f4e703a-e398-42fd-8759-e398c79955f1	2026-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYMORPHONE HYDROCHLORIDE
Oxymorphone Hydrochloride	OXYMORPHONE HYDROCHLORIDE	Epic Pharma, LLC	95804e72-232d-425d-b23d-a66f43bdf0c6	2025-12-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYMORPHONE HYDROCHLORIDE
Oxymorphone Hydrochloride	OXYMORPHONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	3eb971cf-ab82-49f3-a46c-4d76a8ce599e	2025-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYMORPHONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	Camber Pharmaceuticals, Inc	06af7dff-c261-4c03-9cd9-0605c42507fa	2025-08-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYMORPHONE HYDROCHLORIDE
Oxymorphone hydrochloride	OXYMORPHONE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	557e9610-62d7-42bf-90c1-44215bd8c1f8	2024-01-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYMORPHONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	Bryant Ranch Prepack	560e9425-dfcb-4fb4-a759-b1e3f8f40fdb	2024-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYMORPHONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	XLCare Pharmaceuticals, Inc.	1a1d5061-b62a-49fa-a5b2-4970f51416ae	2020-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYMORPHONE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
60294	SUPPL	2019-10-08
60284	SUPPL	2019-10-07
46415	SUPPL	2016-12-21
46202	SUPPL	2016-12-19
11949	SUPPL	2006-10-23
10773	SUPPL	2006-10-18