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 | Bryant Ranch Prepack | 261132f9-ab96-4901-a660-a80c3e0f9d86 | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone hydrochloride | OXYCODONE HYDROCHLORIDE | Asclemed USA, Inc. | 1bb147d4-1ab6-dd70-e063-6394a90a67a8 | 2024-06-25 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 17f7946d-e889-b736-e063-6394a90a42e0 | 2024-05-08 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Lupin Pharmaceuticals,Inc. | 801cb437-c189-44f5-83eb-a51c365d8a6b | 2024-01-30 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Novel Laboratories, Inc. | 69410bf3-0d3a-41f9-b10a-c4ee3770f728 | 2023-12-09 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | QUAGEN PHARMACEUTICALS LLC | 391701e5-2035-43fa-91ce-d27a1af19492 | 2023-02-02 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Epic Pharma, LLC | cff1eee3-7c02-4f6c-acc5-1f6dcbab92c0 | 2022-12-29 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | XLCare Pharmaceuticals, Inc | e5c8e72d-4ac5-4ca3-9557-6a659d4d8338 | 2021-05-28 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Ascent Pharmaceuticals Inc | de96e2be-66d9-4bcb-a133-221ad32e09f1 | 2017-07-10 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.