Application 019645
- Type
- NDA
- Sponsor
- ROCHE PALO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TORADOL | KETOROLAC TROMETHAMINE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N019645-001 | TORADOL | KETOROLAC TROMETHAMINE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019645-001 | TORADOL | 10MG | TABLET / ORAL | RLD | 1991-12-20 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019645-001 | TORADOL | 10MG | TABLET / ORAL | RLD | 1991-12-20 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1991-12-20 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1991-12-20 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1991-12-20 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1991-12-20 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1991-12-20 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1991-12-20 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1991-12-20 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1991-12-20 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1991-12-20 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | e64feba35796… |
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 |
|---|---|---|---|---|---|---|
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Sportpharm LLC | 0749f61d-12e6-4280-8f41-bd4df81e7ae6 | 2026-08-12 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | REMEDYREPACK INC. | b0aa1137-d0c3-4e4e-b1ec-5fe4b24e570a | 2026-08-06 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Amerisyn LLC | 5734e81e-2471-1314-e063-6294a90ac9fe | 2026-07-22 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | 8accbb78-fc64-45d5-69b0-35c23a1d2a2e | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Apotex Corp. | d9a186ba-74a9-b6d4-1109-1e045ba1763e | 2026-07-16 | Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | HF Acquisition Co LLC, DBA HealthFirst | e46ebc7f-584e-e2b7-e053-2995a90ad17b | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | St. Mary's Medical Park Pharmacy | 2d552135-bde5-5fe9-e063-6394a90af433 | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | REMEDYREPACK INC. | f47d4365-40a8-445b-99cd-49edad6a8ffc | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | HF Acquisition Co LLC, DBA HealthFirst | 54dec321-b4c9-f0d6-e063-6294a90ae231 | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health 107, LLC | dd489c86-08c0-4457-86f3-c4f36a70276c | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Injecta Medcial LLC | 515464a7-16c5-2811-e063-6294a90aa451 | 2026-06-18 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | Preferred Pharmaceuticals Inc. | 1e7ae5af-76b9-49a9-ba14-52b566929c22 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Redpharm Drug | 53cb9528-7640-1fd4-e063-6294a90a74ad | 2026-06-09 | Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | REMEDYREPACK INC. | 26a1761b-90bf-49c6-9e6a-f293af2296ce | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health 107, LLC | f335a030-ffa8-4f42-8166-2f06e036b40d | 2026-06-03 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Injecta Medcial LLC | 521b3d09-df08-fcae-e063-6294a90a6545 | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Preferred Pharmaceuticals Inc. | 92546f61-bbd8-430a-ac92-89dfbe8e2f29 | 2026-05-15 | Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | Redpharm Drug | 51d443f8-716d-af3a-e063-6394a90a56a3 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Preferred Pharmaceuticals Inc. | 337afb4f-789f-4cac-817a-e4286664a71e | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health 107, LLC | f0cd5dfa-7eba-449f-a54a-a5155024a77e | 2026-05-12 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |