Application 020932

Type: NDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROXICODONE	OXYCODONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG	No	No
002	ROXICODONE	OXYCODONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	30MG	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
N020932-001	ROXICODONE	OXYCODONE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL			1998-10-26
N020932-002	ROXICODONE	OXYCODONE HYDROCHLORIDE	30MG	TABLET, EXTENDED RELEASE / ORAL			1998-10-26

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	N020932-001	ROXICODONE	10MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020932-002	ROXICODONE	30MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020932-001	ROXICODONE	10MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020932-002	ROXICODONE	30MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020932-001	ROXICODONE	10MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020932-002	ROXICODONE	30MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020932-001	ROXICODONE	10MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020932-002	ROXICODONE	30MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020932-001	ROXICODONE	10MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020932-002	ROXICODONE	30MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020932-001	ROXICODONE	10MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020932-002	ROXICODONE	30MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020932-001	ROXICODONE	10MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020932-002	ROXICODONE	30MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020932-001	ROXICODONE	10MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020932-002	ROXICODONE	30MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020932-001	ROXICODONE	10MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020932-002	ROXICODONE	30MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020932-001	ROXICODONE	10MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020932-002	ROXICODONE	30MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020932-001	ROXICODONE	10MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020932-002	ROXICODONE	30MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020932-001	ROXICODONE	10MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020932-002	ROXICODONE	30MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020932-001	ROXICODONE	10MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020932-002	ROXICODONE	30MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020932-001	ROXICODONE	10MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020932-002	ROXICODONE	30MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020932-001	ROXICODONE	10MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020932-002	ROXICODONE	30MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020932-001	ROXICODONE	10MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020932-002	ROXICODONE	30MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020932-001	ROXICODONE	10MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020932-002	ROXICODONE	30MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020932-001	ROXICODONE	10MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020932-002	ROXICODONE	30MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020932-001	ROXICODONE	10MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020932-002	ROXICODONE	30MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020932-001	ROXICODONE	10MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020932-002	ROXICODONE	30MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-26	`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 4 · 69 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	KVK-TECH, INC.	338b5391-e5f7-40a2-8b15-57f47cbc4813	2026-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	SpecGx LLC	928227bf-89c5-4c64-9823-0e84cc669388	2026-08-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	585405bc-8b85-286f-e063-6394a90aa5cd	2026-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	KVK-Tech, Inc.	744f5d1c-7427-492c-8994-c8e817793e53	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	57afed61-79db-ca43-e063-6394a90a68eb	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	3ccf459a-fb11-e137-e063-6394a90a5a80	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	685d9709-028e-4422-bf0c-fde577b718a2	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Eywa Pharma Inc	c801963d-f54d-4ed5-82c4-8b278528d3dc	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	bb33bf7f-aa70-4e8a-91b2-4e0400dc328e	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYCODONE HYDROCHLORIDE
OxyContin	OXYCODONE HYDROCHLORIDE	Knoa Pharma LLC	bfdfe235-d717-4855-a3c8-a13d26dadede	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	0e4dd113-87ab-4a5d-846a-446db3cfd469	2026-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	e84ea009-3cab-4721-bd21-1123eccce515	2026-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	KVK-TECH,INC	e73897d6-b920-4300-a564-5dbc9c8e9fe9	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Redpharm Drug	5301d432-7fca-2d72-e063-6394a90a18a4	2026-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	27124cdf-a3e8-474c-9c1e-6fa48f6ddc05	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	424fdfc7-1c92-2e62-e063-6394a90a136b	2026-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	c2c57ae7-86b9-47bb-a31b-ed1c4327ce7f	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Rhodes Pharmaceuticals LLC	a5162476-1217-41c0-bc7e-0a0f123f069f	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYCODONE HYDROCHLORIDE
Roxicodone	OXYCODONE HYDROCHLORIDE	SpecGx LLC	5a8157d3-ba20-4abf-b0d4-6ad141b31d63	2026-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Roxicodone generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	ff7f1268-ddb7-4742-beee-8b12966fe8f9	2026-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYCODONE 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
21281	ORIG	1998-10-26
3773	ORIG	1998-10-26