Application 019583
- Type
- NDA
- Sponsor
- SMITHKLINE BEECHAM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RELAFEN | NABUMETONE | TABLET;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | RELAFEN | NABUMETONE | TABLET;ORAL | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019583-001 | RELAFEN | NABUMETONE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | |
| N019583-002 | RELAFEN | NABUMETONE | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 |
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| 2026-08 | N019583-001 | RELAFEN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019583-002 | RELAFEN | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019583-001 | RELAFEN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019583-002 | RELAFEN | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019583-001 | RELAFEN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019583-002 | RELAFEN | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019583-001 | RELAFEN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019583-002 | RELAFEN | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019583-001 | RELAFEN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019583-002 | RELAFEN | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019583-001 | RELAFEN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019583-002 | RELAFEN | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019583-001 | RELAFEN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019583-002 | RELAFEN | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019583-001 | RELAFEN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019583-002 | RELAFEN | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019583-001 | RELAFEN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019583-002 | RELAFEN | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019583-001 | RELAFEN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019583-002 | RELAFEN | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019583-001 | RELAFEN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019583-002 | RELAFEN | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019583-001 | RELAFEN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019583-002 | RELAFEN | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019583-001 | RELAFEN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019583-002 | RELAFEN | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019583-001 | RELAFEN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019583-002 | RELAFEN | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019583-001 | RELAFEN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019583-002 | RELAFEN | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019583-001 | RELAFEN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019583-002 | RELAFEN | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019583-001 | RELAFEN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019583-002 | RELAFEN | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-24 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019583-001 | RELAFEN | 500MG | TABLET / ORAL | RLD | 1991-12-24 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019583-002 | RELAFEN | 750MG | TABLET / ORAL | RLD | 1991-12-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019583-001 | RELAFEN | 500MG | TABLET / ORAL | RLD | 1991-12-24 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019583-002 | RELAFEN | 750MG | TABLET / ORAL | RLD | 1991-12-24 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019583-001 | RELAFEN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1991-12-24 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019583-002 | RELAFEN | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1991-12-24 | 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 |
|---|---|---|---|---|---|---|
| Nabumetone | NABUMETONE | Bryant Ranch Prepack | b2a41c0b-e2ad-4e14-a2f7-2049c12c35da | 2025-03-31 | Boxed warning, Warnings, Adverse reactions | NABUMETONE |
| Nabumetone | NABUMETONE | Bryant Ranch Prepack | ad9f2a34-6244-49b7-98ee-af18cb55693c | 2025-03-31 | Boxed warning, Warnings, Adverse reactions | NABUMETONE |
| Nabumetone | NABUMETONE | Bryant Ranch Prepack | 06f73fa8-7a8f-4160-939e-a25980a11906 | 2025-03-31 | Boxed warning, Warnings, Adverse reactions | NABUMETONE |
| Nabumetone | NABUMETONE | Bryant Ranch Prepack | 5a66c21f-4f06-4fb8-98fa-e81949586afd | 2025-03-31 | Boxed warning, Warnings, Adverse reactions | NABUMETONE |
| Nabumetone | NABUMETONE | Bryant Ranch Prepack | 419c597f-6a6f-4420-b240-7dc4c223387e | 2025-03-27 | Boxed warning, Warnings, Adverse reactions | NABUMETONE |
| Nabumetone | NABUMETONE | Bryant Ranch Prepack | a4553637-498e-491a-982a-cff81b43aa6c | 2025-03-27 | Boxed warning, Warnings, Adverse reactions | NABUMETONE |
| Nabumetone | NABUMETONE | Bryant Ranch Prepack | 5ba602e9-846e-42b3-9ea6-fb461a948947 | 2025-03-26 | Boxed warning, Warnings, Adverse reactions | NABUMETONE |
| Nabumetone | NABUMETONE | Bryant Ranch Prepack | 0be7ee60-2706-43ed-98ec-b89cd4e2b57c | 2025-03-26 | Boxed warning, Warnings, Adverse reactions | NABUMETONE |
| Nabumetone | NABUMETONE | Exelan Pharmaceuticals Inc. | 16e76e29-9315-40c0-b1d6-8d91961063cf | 2025-03-19 | Boxed warning, Warnings, Adverse reactions | NABUMETONE |
| Nabumetone | NABUMETONE | Cipla USA Inc. | 85954380-a520-46d7-89ac-e4b19d6e00a1 | 2025-03-19 | Boxed warning, Warnings, Adverse reactions | NABUMETONE |
| Nabumetone | NABUMETONE | PD-Rx Pharmaceuticals, Inc. | 69620c53-b37a-45b9-b560-221bbcd98fda | 2025-02-04 | Boxed warning, Warnings, Adverse reactions | NABUMETONE |
| NABUMETONE | NABUMETONE | direct rx | a8600b12-f180-0b27-e053-2995a90acbd9 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | NABUMETONE |
| Nabumetone | NABUMETONE | ScieGen Pharmaceuticals Inc | 80c6888d-03b4-44f3-b94d-bcf5154ceae5 | 2025-01-13 | Boxed warning, Warnings, Adverse reactions | NABUMETONE |
| Nabumetone | NABUMETONE | Advanced Rx of Tennessee, LLC | af9969df-ce14-c0bc-e053-2995a90a3f59 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | NABUMETONE |
| Nabumetone | NABUMETONE | Advanced Rx of Tennessee, LLC | af9994ac-6687-2df2-e053-2995a90a959a | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | NABUMETONE |
| Nabumetone | NABUMETONE | Advanced Rx Pharmacy of Tennessee, LLC | b43db4aa-6013-3942-e053-2a95a90a5189 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | NABUMETONE |
| Nabumetone | NABUMETONE | Quality Care Products, LLC | da259c7c-6f1e-403c-b42b-596d53b61fe5 | 2024-12-18 | Boxed warning, Warnings, Adverse reactions | NABUMETONE |
| Nabumetone | NABUMETONE | Quality Care Products, LLC | 065fdacc-739e-4b46-bebc-044b5c11bbbb | 2024-12-18 | Boxed warning, Warnings, Adverse reactions | NABUMETONE |
| Nabumetone | NABUMETONE | A-S Medication Solutions | 26037234-daca-4f1a-a7a7-0871f77283f0 | 2024-11-13 | Boxed warning, Warnings, Adverse reactions | NABUMETONE |
| Nabumetone | NABUMETONE | A-S Medication Solutions | d997d125-dfc5-4cc5-b7a6-03f5a7248d14 | 2024-10-25 | Boxed warning, Warnings, Adverse reactions | NABUMETONE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.