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| KETOROLAC TROMETHAMINE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TORADOL | KETOROLAC TROMETHAMINE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | 84e616aacf4f… | |
| 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| 2026-07 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | caaa826d4ba7… | |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UTC | 2026-02 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | 011fe1cb6892… | |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this ZIP | 2025-12 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | 31067a03dcf5… | |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UTC | 2025-08 | N019645-001 | TORADOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1991-12-20 | 6a471c1ec25d… | |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… |
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 | 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 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Sportpharm LLC | 3efb4f4e-b849-3bb5-e063-6394a90a5305 | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Direct_rx | 22de8e1c-5e68-fd78-e063-6394a90ad40b | 2026-03-17 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | NuCare Pharmaceuticals,Inc. | c2290fd1-2985-1275-e053-2995a90ad5fa | 2026-03-13 | Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Direct_Rx | 19fffe42-a02d-26eb-e063-6294a90aea5a | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Aurobindo Pharma Limited | 007a4da5-d794-416c-94b3-6ee9e7842c52 | 2026-02-26 | Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Major Pharmaceuticals | 48245718-a2df-4938-8d06-3b8abf34181e | 2026-02-19 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | Bryant Ranch Prepack | 23e7b5f7-ea0d-468d-9d13-a95f9bf605c6 | 2026-02-16 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | Baxter Healthcare Corporation | 30a3ca20-8f98-478c-8a6b-aa617f0a17a3 | 2026-02-13 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | REMEDYREPACK INC. | 43d07956-90ba-4e96-b265-aec03eced19b | 2026-02-13 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Civica, Inc. | 32198544-4a46-495c-ab65-0836dcbc2c49 | 2026-02-02 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Redpharm Drug | 49ade79d-4d23-6611-e063-6294a90adfaa | 2026-01-31 | Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Toronova II SUIK | KETOROLAC TROMETHAMINE | Advanced Rx of Tennessee, LLC | 49dd153c-10e8-505b-e063-6394a90a595f | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | GLENMARK PHARMACEUTICALS INC., USA | ce992bee-a9f5-48bd-a00e-513f590d69f2 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Nephron Pharmaceuticals Corporation | ae6c60c0-e88a-45b2-e053-2995a90ac62f | 2026-01-08 | Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.