Application 201655

Type: NDA
Sponsor: ENDO PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OPANA ER	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG	Yes	No
002	OPANA ER	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	7.5MG	Yes	No
003	OPANA ER	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG	Yes	No
004	OPANA ER	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	15MG	Yes	No
005	OPANA ER	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	20MG	Yes	No
006	OPANA ER	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	30MG	Yes	No
007	OPANA ER	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	40MG	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N201655-001	OPANA ER	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09
N201655-002	OPANA ER	OXYMORPHONE HYDROCHLORIDE	7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09
N201655-003	OPANA ER	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09
N201655-004	OPANA ER	OXYMORPHONE HYDROCHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09
N201655-005	OPANA ER	OXYMORPHONE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09
N201655-006	OPANA ER	OXYMORPHONE HYDROCHLORIDE	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09
N201655-007	OPANA ER	OXYMORPHONE HYDROCHLORIDE	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09

Orange Book patents#

Current patent rows page 1 of 1 · 21 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N201655-001	8808737	2027-06-21	U-1598		2014-11-07
N201655-001	7851482	2029-07-10		Drug substance	2012-03-22
N201655-001	8871779	2029-11-22		Drug substance	2014-11-07
N201655-002	8808737	2027-06-21	U-1598		2014-11-07
N201655-002	7851482	2029-07-10		Drug substance
N201655-002	8871779	2029-11-22		Drug substance	2014-11-07
N201655-003	8808737	2027-06-21	U-1598		2014-11-07
N201655-003	7851482	2029-07-10		Drug substance
N201655-003	8871779	2029-11-22		Drug substance	2014-11-07
N201655-004	8808737	2027-06-21	U-1598		2014-11-07
N201655-004	7851482	2029-07-10		Drug substance
N201655-004	8871779	2029-11-22		Drug substance	2014-11-07
N201655-005	8808737	2027-06-21	U-1598		2014-11-07
N201655-005	7851482	2029-07-10		Drug substance
N201655-005	8871779	2029-11-22		Drug substance	2014-11-07
N201655-006	8808737	2027-06-21	U-1598		2014-11-07
N201655-006	7851482	2029-07-10		Drug substance
N201655-006	8871779	2029-11-22		Drug substance	2014-11-07
N201655-007	8808737	2027-06-21	U-1598		2014-11-07
N201655-007	7851482	2029-07-10		Drug substance
N201655-007	8871779	2029-11-22		Drug substance	2014-11-07

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 8 · 287 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N201655-001	OPANA ER	5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-002	OPANA ER	7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-003	OPANA ER	10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-004	OPANA ER	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-005	OPANA ER	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-006	OPANA ER	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-007	OPANA ER	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-001	OPANA ER	5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-002	OPANA ER	7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-003	OPANA ER	10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-004	OPANA ER	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-005	OPANA ER	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-006	OPANA ER	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-007	OPANA ER	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201655-001	OPANA ER	5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201655-002	OPANA ER	7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201655-003	OPANA ER	10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201655-004	OPANA ER	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201655-005	OPANA ER	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201655-006	OPANA ER	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201655-007	OPANA ER	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201655-001	OPANA ER	5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201655-002	OPANA ER	7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201655-003	OPANA ER	10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201655-004	OPANA ER	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201655-005	OPANA ER	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201655-006	OPANA ER	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201655-007	OPANA ER	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201655-001	OPANA ER	5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201655-002	OPANA ER	7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201655-003	OPANA ER	10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201655-004	OPANA ER	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201655-005	OPANA ER	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201655-006	OPANA ER	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201655-007	OPANA ER	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201655-001	OPANA ER	5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201655-002	OPANA ER	7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201655-003	OPANA ER	10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201655-004	OPANA ER	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201655-005	OPANA ER	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 52 · 2,051 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N201655-001	8808737	2027-06-21	U-1598		2014-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-001	7851482	2029-07-10		Drug substance	2012-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-001	8871779	2029-11-22		Drug substance	2014-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-002	8808737	2027-06-21	U-1598		2014-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-002	7851482	2029-07-10		Drug substance		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-002	8871779	2029-11-22		Drug substance	2014-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-003	8808737	2027-06-21	U-1598		2014-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-003	7851482	2029-07-10		Drug substance		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-003	8871779	2029-11-22		Drug substance	2014-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-004	8808737	2027-06-21	U-1598		2014-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-004	7851482	2029-07-10		Drug substance		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-004	8871779	2029-11-22		Drug substance	2014-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-005	8808737	2027-06-21	U-1598		2014-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-005	7851482	2029-07-10		Drug substance		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-005	8871779	2029-11-22		Drug substance	2014-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-006	8808737	2027-06-21	U-1598		2014-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-006	7851482	2029-07-10		Drug substance		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-006	8871779	2029-11-22		Drug substance	2014-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-007	8808737	2027-06-21	U-1598		2014-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-007	7851482	2029-07-10		Drug substance		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-007	8871779	2029-11-22		Drug substance	2014-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-001	8192722	2025-09-15		Drug product	2012-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-001	8808737	2027-06-21	U-1598		2014-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-001	7851482	2029-07-10		Drug substance	2012-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-001	8871779	2029-11-22		Drug substance	2014-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-002	8192722	2025-09-15		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-002	8808737	2027-06-21	U-1598		2014-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-002	7851482	2029-07-10		Drug substance		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-002	8871779	2029-11-22		Drug substance	2014-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-003	8192722	2025-09-15		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-003	8808737	2027-06-21	U-1598		2014-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-003	7851482	2029-07-10		Drug substance		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-003	8871779	2029-11-22		Drug substance	2014-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-004	8192722	2025-09-15		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-004	8808737	2027-06-21	U-1598		2014-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-004	7851482	2029-07-10		Drug substance		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-004	8871779	2029-11-22		Drug substance	2014-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-005	8192722	2025-09-15		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-005	8808737	2027-06-21	U-1598		2014-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-005	7851482	2029-07-10		Drug substance		`31067a03dcf5…`

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
35356-820	Opana	oxymorphone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
35356-825	Opana	oxymorphone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
35356-848	Opana	oxymorphone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
35356-849	Opana	oxymorphone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
63481-812	Opana	oxymorphone hydrochloride	Endo Pharmaceuticals, Inc.	NDA	Current
63481-812	Opana	oxymorphone hydrochloride	Endo Pharmaceuticals Inc.	NDA	Current
63481-813	Opana	oxymorphone hydrochloride	Endo Pharmaceuticals, Inc.	NDA	Current
63481-814	Opana	oxymorphone hydrochloride	Endo Pharmaceuticals, Inc.	NDA	Current
63481-814	Opana	oxymorphone hydrochloride	Endo Pharmaceuticals Inc.	NDA	Current
63481-815	Opana	oxymorphone hydrochloride	Endo Pharmaceuticals, Inc.	NDA	Current
63481-815	Opana	oxymorphone hydrochloride	Endo Pharmaceuticals Inc.	NDA	Current
63481-816	Opana	oxymorphone hydrochloride	Endo Pharmaceuticals, Inc.	NDA	Current
63481-817	Opana	oxymorphone hydrochloride	Endo Pharmaceuticals, Inc.	NDA	Current
63481-818	Opana	oxymorphone hydrochloride	Endo Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
60452	SUPPL	2019-10-09
60403	SUPPL	2019-10-09
60402	SUPPL	2019-10-07
55716	SUPPL	2018-10-01
55715	SUPPL	2018-10-01
55578	SUPPL	2018-09-24
55577	SUPPL	2018-09-24
48584	SUPPL	2017-05-31
46424	SUPPL	2016-12-21
46307	SUPPL	2016-12-20
45455	SUPPL	2016-10-03
32129	SUPPL	2016-04-22
32128	SUPPL	2015-07-07
40080	SUPPL	2015-01-30
9919	SUPPL	2015-01-29
9918	SUPPL	2014-08-20
9917	SUPPL	2014-04-17
40079	SUPPL	2014-04-16
9916	SUPPL	2013-04-18
32127	SUPPL	2013-01-16
19028	SUPPL	2013-01-14
24398	ORIG	2012-08-27
22854	ORIG	2012-08-27
40078	SUPPL	2012-07-12
9915	SUPPL	2012-07-11
44574	ORIG	2012-01-05
40077	ORIG	2011-12-09
32126	ORIG	2011-12-09