Application 019698
- Type
- NDA
- Sponsor
- ROCHE PALO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TORADOL | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | TORADOL | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N019698-001 | TORADOL | KETOROLAC TROMETHAMINE | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | |
| N019698-002 | TORADOL | KETOROLAC TROMETHAMINE | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 |
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| 2026-08 | N019698-001 | TORADOL | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019698-002 | TORADOL | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019698-001 | TORADOL | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019698-002 | TORADOL | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019698-001 | TORADOL | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019698-002 | TORADOL | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019698-001 | TORADOL | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019698-002 | TORADOL | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019698-001 | TORADOL | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019698-002 | TORADOL | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019698-001 | TORADOL | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019698-002 | TORADOL | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019698-001 | TORADOL | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019698-002 | TORADOL | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019698-001 | TORADOL | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019698-002 | TORADOL | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019698-001 | TORADOL | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019698-002 | TORADOL | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019698-001 | TORADOL | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019698-002 | TORADOL | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019698-001 | TORADOL | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019698-002 | TORADOL | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019698-001 | TORADOL | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019698-002 | TORADOL | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019698-001 | TORADOL | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019698-002 | TORADOL | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019698-001 | TORADOL | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019698-002 | TORADOL | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019698-001 | TORADOL | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019698-002 | TORADOL | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019698-001 | TORADOL | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019698-002 | TORADOL | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019698-001 | TORADOL | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019698-002 | TORADOL | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019698-001 | TORADOL | 15MG/ML | INJECTABLE / INJECTION | RLD | 1989-11-30 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019698-002 | TORADOL | 30MG/ML | INJECTABLE / INJECTION | RLD | 1989-11-30 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019698-001 | TORADOL | 15MG/ML | INJECTABLE / INJECTION | RLD | 1989-11-30 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019698-002 | TORADOL | 30MG/ML | INJECTABLE / INJECTION | RLD | 1989-11-30 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019698-001 | TORADOL | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019698-002 | TORADOL | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| Toronova II SUIK | KETOROLAC TROMETHAMINE | Asclemed USA, Inc. | b574ccc9-936c-4877-bd65-7f58f741b5e6 | 2024-03-20 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | Leading Pharma, LLC | 04df9620-6dcb-494a-83e2-6d28036be974 | 2024-02-16 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | A-S Medication Solutions | a1ebb51e-4658-4852-bf90-1983a3d44783 | 2023-12-10 | Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Bryant Ranch Prepack | f713500a-20b8-8e20-c4cc-956805170335 | 2023-11-28 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Bryant Ranch Prepack | 9e5fde54-2206-4072-afb8-4d06a8d314b1 | 2023-11-28 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | A-S Medication Solutions | e0065781-ea33-4662-a8b1-c936e937ac9f | 2023-11-13 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Asclemed USA, Inc. | 94c7c57a-fd1e-41ab-bc39-9a538f6011d1 | 2023-09-06 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Fresenius Kabi USA, LLC | 3d88cbe6-5230-47aa-80af-0c41283d1f00 | 2023-08-31 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Medical Purchasing Solutions, LLC | 9e3ddc51-b572-8fe9-e053-2995a90a2f2a | 2023-05-10 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac tromethamine | KETOROLAC TROMETHAMINE | Medical Purchasing Solutions, LLC | ada639d4-babb-2ad0-e053-2a95a90afce7 | 2023-05-03 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac tromethamine | KETOROLAC TROMETHAMINE | Medical Purchasing Solutions, LLC | e17f583d-8bd4-3ed0-e053-2a95a90a9090 | 2023-04-25 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | A-S Medication Solutions | b88e562d-226b-4200-afa5-034e628c660f | 2023-02-06 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Fresenius Kabi USA, LLC | 950b7295-3f68-4027-ac2b-2f7d0f5f8ef9 | 2022-11-18 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | ATNAHS PHARMA US LIMITED | 57ea681c-392e-4f41-a374-91ed20473161 | 2022-11-01 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Proficient Rx LP | 2f27e304-7a96-47b6-8ef1-8a649c25abcf | 2022-11-01 | Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Camber Pharmaceuticals, Inc. | e1fb8753-4695-4cb2-83d7-15d79fbaeeb2 | 2022-10-18 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Asclemed USA, Inc. | 004588ba-e109-4a53-9c9d-a42dea9bb848 | 2022-10-12 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Fresenius Kabi USA, LLC | ccf905ca-e164-4779-9485-2d139c821bad | 2022-09-15 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac tromethamine | KETOROLAC TROMETHAMINE | Asclemed USA, Inc. | ee44c322-4b4b-4397-a1a5-e5b3c3c5a053 | 2022-09-01 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | Proficient Rx LP | c4598ce4-41fb-4cc9-8102-3a66a9bfa36a | 2022-08-01 | Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.