Application 202321

Type: ANDA
Sponsor: SPECGX LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A202321-001	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL			2013-04-25
A202321-002	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL			2013-04-25

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 · 84 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
2026-08-18 06:07:40	2026-07	A202321-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL		2013-04-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202321-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL		2013-04-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202321-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL		2013-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202321-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL		2013-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202321-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL		2013-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202321-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL		2013-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202321-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL		2013-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202321-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL		2013-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202321-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL		2013-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202321-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL		2013-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202321-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL		2013-04-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202321-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL		2013-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202321-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL		2013-04-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202321-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL		2013-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202321-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL		2013-04-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202321-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL		2013-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202321-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL		2013-04-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202321-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL		2013-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202321-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL		2013-04-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202321-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL		2013-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202321-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL		2013-04-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202321-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL		2013-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202321-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL		2013-04-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202321-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL		2013-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202321-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL		2013-04-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202321-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL		2013-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202321-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL		2013-04-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202321-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL		2013-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202321-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL		2013-04-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202321-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL		2013-04-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202321-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-04-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202321-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2013-04-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202321-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-04-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202321-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2013-04-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202321-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-04-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202321-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2013-04-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202321-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-04-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202321-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2013-04-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202321-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-04-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202321-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2013-04-25	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202321-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202321-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202321-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202321-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202321-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202321-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202321-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202321-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202321-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202321-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202321-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202321-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202321-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202321-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202321-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202321-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202321-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202321-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202321-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202321-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202321-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202321-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202321-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202321-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202321-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202321-002	AB	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A202321-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A202321-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202321-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202321-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202321-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202321-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202321-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202321-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202321-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202321-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202321-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A202321-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202321-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A202321-002	AB	1	`3bdfa0b2c4d7…`

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 brand name: Oxymorphone Hydrochloride 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 brand name: Oxymorphone Hydrochloride 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 brand name: Oxymorphone hydrochloride 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 brand name: Oxymorphone Hydrochloride 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 brand name: Oxymorphone Hydrochloride 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 brand name: OXYMORPHONE HYDROCHLORIDE 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 brand name: Oxymorphone hydrochloride 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 brand name: OXYMORPHONE HYDROCHLORIDE 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 brand name: OXYMORPHONE HYDROCHLORIDE generic name: OXYMORPHONE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0406-1009	OXYMORPHONE HYDROCHLORIDE	Oxymorphone Hydrochloride	SpecGx LLC	ANDA	Current
0406-1009	OXYMORPHONE HYDROCHLORIDE	Oxymorphone Hydrochloride	SpecGx LLC	ANDA	Current
0406-1009	OXYMORPHONE HYDROCHLORIDE	Oxymorphone Hydrochloride	SpecGx LLC	ANDA	Current
0406-1009	OXYMORPHONE HYDROCHLORIDE	Oxymorphone Hydrochloride	SpecGx LLC	ANDA	Current
0406-1010	OXYMORPHONE HYDROCHLORIDE	Oxymorphone Hydrochloride	SpecGx LLC	ANDA	Current
0406-1010	OXYMORPHONE HYDROCHLORIDE	Oxymorphone Hydrochloride	SpecGx LLC	ANDA	Current
0406-1010	OXYMORPHONE HYDROCHLORIDE	Oxymorphone Hydrochloride	SpecGx LLC	ANDA	Current
0406-1010	OXYMORPHONE HYDROCHLORIDE	Oxymorphone Hydrochloride	SpecGx LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76184	ORIG	2023-11-03