Application 020584
- Type
- NDA
- Sponsor
- WYETH PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LODINE XL | ETODOLAC | TABLET, EXTENDED RELEASE;ORAL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 002 | LODINE XL | ETODOLAC | TABLET, EXTENDED RELEASE;ORAL | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | LODINE XL | ETODOLAC | TABLET, EXTENDED RELEASE;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020584-001 | LODINE XL | ETODOLAC | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1996-10-25 | ||
| N020584-002 | LODINE XL | ETODOLAC | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-10-25 | |
| N020584-003 | LODINE XL | ETODOLAC | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1998-01-20 |
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| 2026-08 | N020584-001 | LODINE XL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1996-10-25 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020584-002 | LODINE XL | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-10-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020584-003 | LODINE XL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1998-01-20 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020584-001 | LODINE XL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1996-10-25 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020584-002 | LODINE XL | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-10-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020584-003 | LODINE XL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1998-01-20 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020584-001 | LODINE XL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1996-10-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020584-002 | LODINE XL | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-10-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020584-003 | LODINE XL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1998-01-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020584-001 | LODINE XL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1996-10-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020584-002 | LODINE XL | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-10-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020584-003 | LODINE XL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1998-01-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020584-001 | LODINE XL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1996-10-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020584-002 | LODINE XL | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-10-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020584-003 | LODINE XL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1998-01-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020584-001 | LODINE XL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1996-10-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020584-002 | LODINE XL | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-10-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020584-003 | LODINE XL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1998-01-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020584-001 | LODINE XL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1996-10-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020584-002 | LODINE XL | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-10-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020584-003 | LODINE XL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1998-01-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020584-001 | LODINE XL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1996-10-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020584-002 | LODINE XL | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-10-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020584-003 | LODINE XL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1998-01-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020584-001 | LODINE XL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1996-10-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020584-002 | LODINE XL | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-10-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020584-003 | LODINE XL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1998-01-20 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020584-001 | LODINE XL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1996-10-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020584-002 | LODINE XL | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-10-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020584-003 | LODINE XL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1998-01-20 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020584-001 | LODINE XL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1996-10-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020584-002 | LODINE XL | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-10-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020584-003 | LODINE XL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1998-01-20 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020584-001 | LODINE XL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1996-10-25 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020584-002 | LODINE XL | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-10-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020584-003 | LODINE XL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1998-01-20 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020584-001 | LODINE XL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1996-10-25 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020584-002 | LODINE XL | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-10-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020584-003 | LODINE XL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1998-01-20 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020584-001 | LODINE XL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1996-10-25 | 301d65b070ca… |
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 |
|---|---|---|---|---|---|---|
| Etodolac | ETODOLAC | Medsource Pharmaceuticals | 12f0685b-2127-d0d6-e063-6394a90a62d1 | 2024-03-05 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | Aphena Pharma Solutions - Tennessee, LLC | 113558e6-8b45-cdbd-e063-6394a90ac036 | 2024-02-19 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | Aphena Pharma Solutions - Tennessee, LLC | 1149072a-280a-2b11-e063-6394a90ac107 | 2024-02-19 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | Aphena Pharma Solutions - Tennessee, LLC | 420b1ed5-e9f2-43dd-8d3c-ca9896221aca | 2024-01-29 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | A-S Medication Solutions | 06f602d1-6faf-41c8-bcfd-33e51f4ca636 | 2023-10-17 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | Proficient Rx LP | e2fef939-2f4a-46ae-8177-073f5e8f57f5 | 2023-08-01 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | A-S Medication Solutions | 31a55fb1-9721-4202-af7d-f06074b03102 | 2023-06-29 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | A-S Medication Solutions | 74baa6ad-b517-48e2-8cef-d77f5755b279 | 2023-02-04 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | Proficient Rx LP | 0fce1aea-5de2-4acb-8a21-2b775c4adb25 | 2023-01-01 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | Proficient Rx LP | 0c783997-6f2a-45ae-b899-c060c8be468a | 2022-11-01 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | Doc Rx | cdde46e5-1123-410f-aafc-0c6e904a5d5b | 2021-09-28 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | Proficient Rx LP | 4712e069-83b6-4052-8d95-f59ab1dba744 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | Proficient Rx LP | 449b273a-936a-4c49-b0c8-d0daa47733ae | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 34884 | SUPPL | 2006-01-20 |
| 25233 | SUPPL | 2006-01-20 |
| 34883 | SUPPL | 2005-05-26 |
| 34882 | SUPPL | 2005-05-26 |
| 25232 | SUPPL | 2005-05-26 |
| 12773 | SUPPL | 2005-05-26 |
| 2782 | SUPPL | 2005-05-26 |
| 2781 | SUPPL | 2005-05-26 |
| 41447 | SUPPL | 2003-09-11 |
| 20738 | SUPPL | 2001-11-09 |
| 20737 | SUPPL | 2001-07-18 |
| 25231 | SUPPL | 2000-08-11 |
| 12772 | SUPPL | 2000-08-11 |
| 34881 | SUPPL | 1999-05-27 |
| 25230 | SUPPL | 1999-05-27 |