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 | Asclemed USA, Inc. | 056bdaac-4a43-42f0-9435-f349d3ccc128 | 2025-12-27 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Aurolife Pharma, LLC | 96ad4352-fff3-46a7-85de-466cc161045e | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Redpharm Drug | 3745020d-df8c-7209-e063-6394a90aabd7 | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Redpharm Drug | 439c2de6-3ea5-e829-e063-6294a90aa77d | 2025-12-02 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | 73b063b5-24b7-40bf-bc2a-c0e1bfaf61d1 | 2025-11-28 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | American Health Packaging | aa7ac2bf-d9ed-445d-b394-4d3fe39780ca | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 08977126-9671-4d87-9724-1599ca86e181 | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | ST. MARY'S MEDICAL PARK PHARMACY | 3cd01fb7-b59c-fc5d-e063-6394a90a21d2 | 2025-08-20 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | ST. MARY'S MEDICAL PARK PHARMACY | 3ca9f0d9-a40d-4416-e063-6394a90aec8b | 2025-08-18 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | DIRECT RX | a8206207-ad09-83df-e053-2995a90a78b7 | 2025-06-05 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | RedPharm Drug, Inc. | 92614a3a-331d-16ad-e053-2a95a90a47cc | 2025-04-09 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | American Health Packaging | 0a6b0659-6816-4f44-81bd-9bac4da5380d | 2025-03-20 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | e2e52a0e-a80b-4225-b034-37a62f839d92 | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Asclemed USA, Inc. | c10cc127-8756-4ddc-9f46-1e003ef271dc | 2025-01-08 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Quality Care Products LLC | 4cadb809-157d-49cc-97b4-3276594f19d2 | 2024-12-19 | Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Precision Dose, Inc. | f849c7cc-fa85-47eb-be30-1be137913bf9 | 2024-12-17 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | d9841f2d-d182-4888-9a3c-68e1afb3e19c | 2024-11-20 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | 3eddd18b-695a-4e53-a76c-f6779515b918 | 2024-09-12 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ef58f422-682e-6896-e053-2a95a90a1f2d | 2024-09-06 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 1bcddbe1-c453-43ec-a822-9e993b885a5f | 2024-08-27 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.