Application 020932
- Type
- NDA
- Sponsor
- ROXANE
Application Products#
| 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 |
Orange Book products#
| 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.
| 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 | N020932-001 | ROXICODONE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020932-002 | ROXICODONE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020932-001 | ROXICODONE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020932-002 | ROXICODONE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020932-001 | ROXICODONE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020932-002 | ROXICODONE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020932-001 | ROXICODONE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020932-002 | ROXICODONE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020932-001 | ROXICODONE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020932-002 | ROXICODONE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020932-001 | ROXICODONE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020932-002 | ROXICODONE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020932-001 | ROXICODONE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020932-002 | ROXICODONE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020932-001 | ROXICODONE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020932-002 | ROXICODONE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020932-001 | ROXICODONE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020932-002 | ROXICODONE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020932-001 | ROXICODONE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020932-002 | ROXICODONE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020932-001 | ROXICODONE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020932-002 | ROXICODONE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020932-001 | ROXICODONE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020932-002 | ROXICODONE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020932-001 | ROXICODONE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020932-002 | ROXICODONE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020932-001 | ROXICODONE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020932-002 | ROXICODONE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020932-001 | ROXICODONE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020932-002 | ROXICODONE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N020932-001 | ROXICODONE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N020932-002 | ROXICODONE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020932-001 | ROXICODONE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020932-002 | ROXICODONE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N020932-001 | ROXICODONE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N020932-002 | ROXICODONE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N020932-001 | ROXICODONE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N020932-002 | ROXICODONE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 1998-10-26 | 4b0b4de00fa7… | ||
| 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… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Genus Lifesciences Inc. | 6869fec9-1837-4221-afd8-5cc6fadd025d | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 6de58d48-d6fc-46b4-ab7c-9ffdede855dc | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | a1e539ba-2cb5-4815-8c58-37abfd978fa5 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 7503ef9d-0fad-421f-951a-f35ab71f71c7 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 22f9eeaa-8aad-44f6-8258-e41edb60f876 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | e0079cc8-3642-47f0-9d14-28fd8f212c21 | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 1a190488-3444-43b0-b9c8-45c1eb371aad | 2026-03-27 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 35030c55-47e6-44cb-9d96-0c3cd5d0c238 | 2026-03-24 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | bdade691-3687-3308-e053-2995a90ad6ed | 2026-02-20 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | 819ed9fc-0a21-4ed0-9080-91912c5f8ce2 | 2026-02-12 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | MAJOR PHARMACEUTICALS | e4fbf3fd-8755-4699-9a61-ba7fada0f93f | 2026-02-02 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | 5df92fed-6194-4905-9ef2-9eed0d2e8086 | 2026-01-22 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| oxycodone hydrochloride | OXYCODONE HYDROCHLORIDE | Hikma Pharmceuticals USA Inc. | d8e87c66-f872-4e1d-9ade-ef11490af63b | 2026-01-20 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Eywa Pharma Inc | 685f409f-946f-4b7e-8130-5ad7b92a5e7a | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Camber Pharmaceuticals Inc | 01db4606-d49c-4b10-a78a-1cf41880a9fb | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | MAJOR PHARMACEUTICALS | 6d249bc5-79c4-4c42-a71b-d667c75163db | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| RoxyBond | OXYCODONE HYDROCHLORIDE | Protega Pharmaceuticals Inc | 72398542-8e0a-47b2-afeb-9ca5a1f15083 | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Strides Pharma Science Limited | f3116ebf-d72c-4e98-aa50-006be4770c86 | 2026-01-09 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| OXAYDO | OXYCODONE HYDROCHLORIDE | Zyla Life Sciences US LLC | cff0c64a-63f5-4b3c-909a-cdecf6755cbe | 2026-01-04 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone hydrochloride | OXYCODONE HYDROCHLORIDE | Alvogen, Inc. | 20bb6bb4-230a-c9c2-01d8-a6e9341e96ba | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.