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ETODOLAC | TABLET, EXTENDED RELEASE;ORAL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |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ETODOLAC | TABLET, EXTENDED RELEASE;ORAL | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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ETODOLAC | TABLET, EXTENDED RELEASE;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |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| N020584-001 | LODINE XL | ETODOLAC | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1996-10-25 | ||
| N020584-002 | LODINE XL | ETODOLAC | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-10-25 | |
| N020584-003 | LODINE XL | ETODOLAC | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1998-01-20 |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| 2026-08 | N020584-001 | LODINE XL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | 1996-10-25 | 84e616aacf4f… | ||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 | Ipca Laboratories Limited | f50a93ca-584a-4205-a79b-31bafdd309c2 | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| etodolac | ETODOLAC | Ipca Laboratories Limited | d583988c-3e7e-4415-b2fd-34049791cd1c | 2026-01-21 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | A-S Medication Solutions | 336d5331-4d60-42e2-8cfc-aad57c01eda0 | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | A-S Medication Solutions | 00125d63-d8d0-46c5-bdf1-80d2c85eda5a | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | A-S Medication Solutions | 4d392c1b-95c2-4925-98bf-0203c412d3da | 2026-01-05 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | Northwind Health Company, LLC | 7ec87ffd-057e-420c-b8f2-0a6eed4152be | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | Northwind Health Company, LLC | b0880f39-a6fa-23ab-e053-2995a90a7eb2 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | Northwind Health Company, LLC | da34581d-3066-711c-e053-2995a90a8e84 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | ANI Pharmaceuticals, Inc. | 420c7b62-3bea-4d6b-82e0-ab1c176c7f1e | 2025-12-22 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | Edenbridge Pharmaceuticals LLC. | bf1afcd5-e1da-4874-981f-f252cb0b32c2 | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | PD-Rx Pharmaceuticals, Inc. | 80e9d756-9278-48bb-bfdd-7d070ae0f341 | 2025-12-16 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | Chartwell RX, LLC | f86d2b22-d3f7-49cd-98f6-cdb2bd855192 | 2025-12-09 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | Unichem Pharmaceuticals (USA), Inc. | 18215cb7-c833-4a98-a61d-4bedf518a380 | 2025-12-09 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | Bryant Ranch Prepack | 479bce92-2066-46ed-b4bb-8c7a59edfffd | 2025-11-14 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | Bryant Ranch Prepack | 5e94a98f-d36e-4f28-b79c-6ad8a6793381 | 2025-10-22 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | Apotex Corp. | 4d682f98-1e8a-4c2b-6df3-169d2ed10dc1 | 2025-09-18 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | Advanced Rx of Tennessee, LLC | 3d865ff0-fc45-1e95-e063-6294a90a8e18 | 2025-08-29 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | NORTHSTAR RX LLC | 107ea9d7-80a9-41a4-b61e-168370127319 | 2025-06-24 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | Preferred Pharmaceuticals Inc. | 556a7d5f-2c3c-4efb-ac0c-fca140791602 | 2025-03-24 | Boxed warning, Warnings, Adverse reactions | ETODOLAC |
| Etodolac | ETODOLAC | A-S Medication Solutions | a7d91fcf-7928-4c9e-862b-6922d6e47c9d | 2025-02-06 | 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 |