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TROMETHAMINE | INJECTABLE;INJECTION | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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TROMETHAMINE | INJECTABLE;INJECTION | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TORADOL | KETOROLAC TROMETHAMINE | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | |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| TORADOL | KETOROLAC TROMETHAMINE | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 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| 2026-07 | N019698-001 | TORADOL | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | caaa826d4ba7… | |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| 2026-07 | N019698-002 | TORADOL | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | caaa826d4ba7… | |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UTC | 2026-02 | N019698-001 | TORADOL | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1989-11-30 | 011fe1cb6892… | |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… | |
| 2022-03-09 01:35 UTC | 2022-03 | 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 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | 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 | bb7c543d1eb4… |
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 | Medical Purchasing Solutions, LLC | 46434a32-b727-0c5b-e063-6394a90a0c48 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Redpharm Drug | 37453bcd-e34b-5902-e063-6294a90a0245 | 2025-12-13 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | Amici Pharma Inc. | 8b26240c-b72b-42a6-ab33-a1e38224fbe0 | 2025-12-10 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | SOLA Pharmaceuticals, LLC | 2301a6a2-b88a-4c0d-bb6c-ad4a8af7da39 | 2025-12-08 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | SOLA Pharmaceuticals, LLC | b08a46f3-36c9-405d-a963-9739a5c87f9c | 2025-12-08 | Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Chartwell RX, LLC | 3855f527-fd6c-4f24-a4b4-cd47eec1193d | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | A-S Medication Solutions | d8e928ac-c1e7-4b7a-87cd-9d11e36d53c0 | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | A-S Medication Solutions | 3321b610-1c9b-4314-adbb-a2e163234dec | 2025-11-18 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac tromethamine | KETOROLAC TROMETHAMINE | A-S Medication Solutions | 5e42914f-de71-4176-819b-9fa26a8bdce6 | 2025-11-12 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | Sandoz Inc | 79e29a86-1b44-4d95-8d84-5a2e8f23ddcf | 2025-10-27 | Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Sagent Pharmaceuticals | 62591551-a644-4b2c-a0de-982e906fabc3 | 2025-10-25 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health 107, LLC | 63b73913-246d-4e5b-bdc9-c202980d8777 | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health 107, LLC | 6758cb38-dec8-468f-94e2-613772e39b9a | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | A-S Medication Solutions | 49e04373-568d-48fa-ac1c-b7d6b493e777 | 2025-10-14 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Proficient Rx LP | 38fc11a0-50d1-4ba5-8d46-331eb74a00d6 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | REMEDYREPACK INC. | cdd4d548-33f8-42d6-8eae-e36aa577c050 | 2025-09-30 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | Onesource Specialty Pharma Limited | 4596483b-990b-eaa4-e063-6394a90ac08f | 2025-09-30 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | Onesource Specialty Pharma Limited | 45966992-5af6-bf10-e063-6294a90af25b | 2025-09-30 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Micro Labs Limited | 631c2c31-cd4f-4a17-85c6-be96746a753e | 2025-09-29 | Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Preferred Pharmaceuticals Inc. | 18b450d2-e715-4710-a1d8-22b782f87f9c | 2025-09-23 | Boxed warning, Warnings, Adverse reactions | KETOROLAC TROMETHAMINE |