Application 018922
- Type
- NDA
- Sponsor
- WYETH PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | LODINE | ETODOLAC | CAPSULE;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | LODINE | ETODOLAC | CAPSULE;ORAL | 300MG | Yes | No |
| 004 | LODINE | ETODOLAC | TABLET;ORAL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 005 | LODINE | ETODOLAC | TABLET;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N018922-002 | LODINE | ETODOLAC | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1991-01-31 | |
| N018922-003 | LODINE | ETODOLAC | 300MG | CAPSULE / ORAL | RLD | 1991-01-31 | |
| N018922-004 | LODINE | ETODOLAC | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-07-29 | |
| N018922-005 | LODINE | ETODOLAC | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-06-28 |
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| 2026-08 | N018922-002 | LODINE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1991-01-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N018922-003 | LODINE | 300MG | CAPSULE / ORAL | RLD | 1991-01-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N018922-004 | LODINE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-07-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N018922-005 | LODINE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-06-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N018922-002 | LODINE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1991-01-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N018922-003 | LODINE | 300MG | CAPSULE / ORAL | RLD | 1991-01-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N018922-004 | LODINE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-07-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N018922-005 | LODINE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-06-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018922-002 | LODINE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1991-01-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018922-003 | LODINE | 300MG | CAPSULE / ORAL | RLD | 1991-01-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018922-004 | LODINE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-07-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018922-005 | LODINE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-06-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018922-002 | LODINE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1991-01-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018922-003 | LODINE | 300MG | CAPSULE / ORAL | RLD | 1991-01-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018922-004 | LODINE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-07-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018922-005 | LODINE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-06-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018922-002 | LODINE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1991-01-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018922-003 | LODINE | 300MG | CAPSULE / ORAL | RLD | 1991-01-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018922-004 | LODINE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-07-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018922-005 | LODINE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-06-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018922-002 | LODINE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1991-01-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018922-003 | LODINE | 300MG | CAPSULE / ORAL | RLD | 1991-01-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018922-004 | LODINE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-07-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018922-005 | LODINE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-06-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018922-002 | LODINE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1991-01-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018922-003 | LODINE | 300MG | CAPSULE / ORAL | RLD | 1991-01-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018922-004 | LODINE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-07-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018922-005 | LODINE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-06-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018922-002 | LODINE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1991-01-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018922-003 | LODINE | 300MG | CAPSULE / ORAL | RLD | 1991-01-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018922-004 | LODINE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-07-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018922-005 | LODINE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-06-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018922-002 | LODINE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1991-01-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018922-003 | LODINE | 300MG | CAPSULE / ORAL | RLD | 1991-01-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018922-004 | LODINE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-07-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018922-005 | LODINE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-06-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018922-002 | LODINE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1991-01-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018922-003 | LODINE | 300MG | CAPSULE / ORAL | RLD | 1991-01-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018922-004 | LODINE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-07-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018922-005 | LODINE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-06-28 | 5bbf6a4d5a75… |
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.