Application 200534

Type: NDA
Sponsor: GENUS LIFESCIENCES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	CAPSULE;ORAL	5MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N200534-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N200534-001	AB

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N200534-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N200534-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N200534-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200534-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200534-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200534-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200534-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200534-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200534-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200534-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200534-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200534-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200534-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200534-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200534-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N200534-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200534-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N200534-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N200534-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N200534-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N200534-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N200534-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200534-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N200534-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N200534-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N200534-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N200534-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N200534-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N200534-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N200534-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N200534-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N200534-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N200534-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N200534-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N200534-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N200534-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N200534-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N200534-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N200534-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N200534-001	AB	1	`f41ea6bd6efb…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200534-001	M-14	2024-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200534-001	M-14	2024-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200534-001	M-14	2024-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200534-001	M-14	2024-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200534-001	M-14	2024-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200534-001	M-14	2024-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200534-001	M-14	2024-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200534-001	M-14	2024-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N200534-001	M-14	2024-07-21	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N200534-001	M-14	2024-07-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N200534-001	M-14	2024-07-21	`1c564ffb4f44…`

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 4 of 4 · 78 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	3eddd18b-695a-4e53-a76c-f6779515b918	2024-09-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ef58f422-682e-6896-e053-2a95a90a1f2d	2024-09-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	1bcddbe1-c453-43ec-a822-9e993b885a5f	2024-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	261132f9-ab96-4901-a660-a80c3e0f9d86	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone hydrochloride	OXYCODONE HYDROCHLORIDE	Asclemed USA, Inc.	1bb147d4-1ab6-dd70-e063-6394a90a67a8	2024-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	b2510d72-bf63-4c9d-ac5e-7bacd993fa10	2024-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	232d44d2-3924-4d35-873c-d2aef75e9a41	2024-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	d248ceba-9492-4348-aa07-31c9c73a3620	2024-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	bc7fdf7e-ad4e-4a04-b35c-2233cc7e5f15	2024-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	4e9e945d-5ffc-48de-99fa-3fb36c5bc2b9	2024-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	9da42120-0214-45cb-bb98-9a7739e72d43	2024-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	17f7946d-e889-b736-e063-6394a90a42e0	2024-05-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OXYCODONE HYDROCHLORIDE generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Lupin Pharmaceuticals,Inc.	801cb437-c189-44f5-83eb-a51c365d8a6b	2024-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Novel Laboratories, Inc.	69410bf3-0d3a-41f9-b10a-c4ee3770f728	2023-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	QUAGEN PHARMACEUTICALS LLC	391701e5-2035-43fa-91ce-d27a1af19492	2023-02-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OXYCODONE HYDROCHLORIDE generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Epic Pharma, LLC	cff1eee3-7c02-4f6c-acc5-1f6dcbab92c0	2022-12-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	XLCare Pharmaceuticals, Inc	e5c8e72d-4ac5-4ca3-9557-6a659d4d8338	2021-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Ascent Pharmaceuticals Inc	de96e2be-66d9-4bcb-a133-221ad32e09f1	2017-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OXYCODONE HYDROCHLORIDE generic name: OXYCODONE HYDROCHLORIDE

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63629-3803	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
64950-901	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Genus Lifesciences Inc.	NDA	Current
64950-901	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Genus Lifesciences Inc.	NDA	Current
64950-901	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Genus Lifesciences Inc.	NDA	Current
64950-901	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Genus Lifesciences Inc.	NDA	Current
68462-204	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Glenmark Pharmaceuticals, Inc	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84638	SUPPL	2026-01-05
84568	SUPPL	2025-12-29
80080	SUPPL	2024-11-04
78217	SUPPL	2024-04-23
78216	SUPPL	2024-04-23
78187	SUPPL	2024-04-22
77052	SUPPL	2023-12-19
76944	SUPPL	2023-12-18
76240	ORIG	2023-11-03
68171	SUPPL	2021-07-23
68170	SUPPL	2021-07-23
68159	SUPPL	2021-07-22
66629	SUPPL	2021-03-08
66628	SUPPL	2021-03-08
66571	SUPPL	2021-03-08
60449	SUPPL	2019-10-09
60395	SUPPL	2019-10-08
60394	SUPPL	2019-10-08
55999	SUPPL	2018-10-17
55998	SUPPL	2018-10-17
55728	SUPPL	2018-10-01
55727	SUPPL	2018-10-01
46412	SUPPL	2016-12-21
46327	SUPPL	2016-12-20
44822	ORIG	2011-02-24
22832	ORIG	2011-02-24
32031	ORIG	2010-10-26
18963	ORIG	2010-10-21