Application 204216
- Type
- ANDA
- Sponsor
- GLAND PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 15MG/ML | No | No |
| 002 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 30MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204216-001 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | |
| A204216-002 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204216-001 | AP |
| A204216-002 | AP |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A204216-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204216-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204216-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204216-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204216-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204216-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204216-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204216-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204216-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204216-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204216-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204216-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204216-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204216-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204216-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204216-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204216-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204216-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A204216-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204216-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204216-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204216-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204216-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204216-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204216-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204216-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A204216-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A204216-002 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204216-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204216-002 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A204216-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A204216-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A204216-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A204216-002 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A204216-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A204216-002 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A204216-001 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A204216-002 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A204216-001 | AP | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A204216-002 | AP | 1 | 782e0a99824c… |
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 | REMEDYREPACK INC. | 26a1761b-90bf-49c6-9e6a-f293af2296ce | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Direct_rx | 22de8e1c-5e68-fd78-e063-6394a90ad40b | 2026-03-17 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | REMEDYREPACK INC. | 43d07956-90ba-4e96-b265-aec03eced19b | 2026-02-13 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | Sportpharm LLC | 2a23b0fa-803c-4abb-b588-12cfe83326a9 | 2026-02-03 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Civica, Inc. | 32198544-4a46-495c-ab65-0836dcbc2c49 | 2026-02-02 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | ProPharma Distribution | 42dfd39e-53a3-e9ee-e063-6394a90ab51e | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| Ketorolac tromethamine | KETOROLAC TROMETHAMINE | A-S Medication Solutions | 5e42914f-de71-4176-819b-9fa26a8bdce6 | 2025-11-12 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 50090-5428 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Sagent Pharmaceuticals | 62591551-a644-4b2c-a0de-982e906fabc3 | 2025-10-25 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | ProPharma Distribution | 3f2956d9-9e68-f35e-e063-6394a90a706d | 2025-09-18 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| Ketorolac tromethamine | KETOROLAC TROMETHAMINE | Henry Schein, Inc. | 99c06dde-f218-4d81-91e0-f37a748872d6 | 2025-07-14 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Henry Schein, Inc. | 1e65d11b-5aa9-4a6b-b5d6-c19828748fea | 2025-06-20 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| Ketorolac tromethamine | KETOROLAC TROMETHAMINE | Henry Schein, Inc. | 606b0f2f-de28-42a9-96f4-cacba2c7c56a | 2025-06-19 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | REMEDYREPACK INC. | 6f727e1f-2838-427b-a236-eeb0101b08f3 | 2024-12-06 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | FOSUN PHARMA USA INC | 1aae6a4d-0909-4672-aa26-e3f2d8c4d413 | 2024-09-20 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | Gland Pharma Limited | 5abd4389-4fb2-408b-a27e-cf64b6a921f1 | 2024-09-20 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 68083-133 68083-132 68083-134 |
| Ketorolac tromethamine | KETOROLAC TROMETHAMINE | Medical Purchasing Solutions, LLC | ada639d4-babb-2ad0-e053-2a95a90afce7 | 2023-05-03 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| Ketorolac tromethamine | KETOROLAC TROMETHAMINE | Medical Purchasing Solutions, LLC | e17f583d-8bd4-3ed0-e053-2a95a90a9090 | 2023-04-25 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | A-S Medication Solutions | b88e562d-226b-4200-afa5-034e628c660f | 2023-02-06 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 50090-5609 |
| Ketorolac tromethamine | KETOROLAC TROMETHAMINE | Asclemed USA, Inc. | ee44c322-4b4b-4397-a1a5-e5b3c3c5a053 | 2022-09-01 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Proficient Rx LP | 014ba8d7-7ed3-4d4a-847a-22b65161117e | 2021-07-01 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0404-9883 | KETOROLAC TROMETHAMINE | ketorolac tromethamine | Henry Schein, Inc. | ANDA | Current |
| 0404-9883 | KETOROLAC TROMETHAMINE | ketorolac tromethamine | Henry Schein, Inc. | ANDA | Current |
| 0404-9883 | KETOROLAC TROMETHAMINE | ketorolac tromethamine | Henry Schein, Inc. | ANDA | Current |
| 0404-9884 | Ketorolac Tromethamine | Ketorolac Tromethamine | Henry Schein, Inc. | ANDA | Current |
| 0404-9884 | Ketorolac Tromethamine | Ketorolac Tromethamine | Henry Schein, Inc. | ANDA | Current |
| 0404-9952 | KETOROLAC TROMETHAMINE | ketorolac tromethamine | Henry Schein, Inc. | ANDA | Current |
| 0404-9952 | KETOROLAC TROMETHAMINE | ketorolac tromethamine | Henry Schein, Inc. | ANDA | Current |
| 47781-583 | Ketorolac Tromethamine | ketorolac tromethamine | Alvogen Inc. | ANDA | Current |
| 47781-583 | Ketorolac Tromethamine | ketorolac tromethamine | Alvogen Inc. | ANDA | Current |
| 47781-583 | Ketorolac Tromethamine | ketorolac tromethamine | Alvogen Inc. | ANDA | Current |
| 47781-584 | Ketorolac Tromethamine | ketorolac tromethamine | Alvogen Inc. | ANDA | Current |
| 47781-584 | Ketorolac Tromethamine | ketorolac tromethamine | Alvogen Inc. | ANDA | Current |
| 47781-584 | Ketorolac Tromethamine | ketorolac tromethamine | Alvogen Inc. | ANDA | Current |
| 47781-585 | Ketorolac Tromethamine | ketorolac tromethamine | Alvogen Inc. | ANDA | Current |
| 47781-585 | Ketorolac Tromethamine | ketorolac tromethamine | Alvogen Inc. | ANDA | Current |
| 47781-585 | Ketorolac Tromethamine | ketorolac tromethamine | Alvogen Inc. | ANDA | Current |
| 50090-3261 | Ketorolac Tromethamine | ketorolac tromethamine | A-S Medication Solutions | ANDA | Current |
| 50090-3364 | Ketorolac Tromethamine | ketorolac tromethamine | A-S Medication Solutions | ANDA | Current |
| 50090-3364 | Ketorolac Tromethamine | ketorolac tromethamine | A-S Medication Solutions | ANDA | Current |
| 50090-3397 | Ketorolac Tromethamine | ketorolac tromethamine | A-S Medication Solutions | ANDA | Current |
| 50090-4635 | Ketorolac Tromethamine | ketorolac tromethamine | A-S Medication Solutions | ANDA | Current |
| 50090-5013 | Ketorolac Tromethamine | ketorolac tromethamine | A-S Medication Solutions | ANDA | Current |
| 50090-5013 | Ketorolac Tromethamine | ketorolac tromethamine | A-S Medication Solutions | ANDA | Current |
| 50090-5013 | Ketorolac Tromethamine | ketorolac tromethamine | A-S Medication Solutions | ANDA | Current |
| 50090-5428 | Ketorolac tromethamine | Ketorolac tromethamine | A-S Medication Solutions | ANDA | Current |
| 50090-5428 | Ketorolac tromethamine | Ketorolac tromethamine | A-S Medication Solutions | ANDA | Current |
| 50090-5428 | Ketorolac tromethamine | Ketorolac tromethamine | A-S Medication Solutions | ANDA | Current |
| 50090-5609 | Ketorolac Tromethamine | ketorolac tromethamine | A-S Medication Solutions | ANDA | Current |
| 51662-1488 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1488 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 52584-584 | Ketorolac Tromethamine | Ketorolac Tromethamine | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-584 | Ketorolac Tromethamine | Ketorolac Tromethamine | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-585 | Ketorolac Tromethamine | Ketorolac Tromethamine | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-585 | Ketorolac Tromethamine | Ketorolac Tromethamine | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-585 | Ketorolac Tromethamine | Ketorolac Tromethamine | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-719 | KETOROLAC TROMETHAMINE | ketorolac tromethamine | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-719 | KETOROLAC TROMETHAMINE | ketorolac tromethamine | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-722 | KETOROLAC TROMETHAMINE | ketorolac tromethamine | General Injectables & Vaccines, Inc. | ANDA | Current |
| 52584-722 | KETOROLAC TROMETHAMINE | ketorolac tromethamine | General Injectables & Vaccines, Inc. | ANDA | Current |
| 52584-722 | KETOROLAC TROMETHAMINE | ketorolac tromethamine | General Injectables & Vaccines, Inc. | ANDA | Current |
| 52584-722 | KETOROLAC TROMETHAMINE | ketorolac tromethamine | General Injectables & Vaccines, Inc. | ANDA | Current |
| 52584-725 | Ketorolac Tromethamine | Ketorolac Tromethamine | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-725 | Ketorolac Tromethamine | Ketorolac Tromethamine | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-725 | Ketorolac Tromethamine | Ketorolac Tromethamine | General Injectables and Vaccines, Inc. | ANDA | Current |
| 55154-1555 | Ketorolac Tromethamine | ketorolac tromethamine | Cardinal Health | ANDA | Current |
| 55154-1555 | Ketorolac Tromethamine | ketorolac tromethamine | Cardinal Health | ANDA | Current |
| 55154-1555 | Ketorolac Tromethamine | ketorolac tromethamine | Cardinal Health 107, LLC | ANDA | Current |
| 55154-1555 | Ketorolac Tromethamine | ketorolac tromethamine | Cardinal Health | ANDA | Current |
| 55154-1556 | Ketorolac Tromethamine | ketorolac tromethamine | Cardinal Health | ANDA | Current |
| 55154-1556 | Ketorolac Tromethamine | ketorolac tromethamine | Cardinal Health | ANDA | Current |
| 55154-1556 | Ketorolac Tromethamine | ketorolac tromethamine | Cardinal Health 107, LLC | ANDA | Current |
| 55154-1556 | Ketorolac Tromethamine | ketorolac tromethamine | Cardinal Health | ANDA | Current |
| 55154-1556 | Ketorolac Tromethamine | ketorolac tromethamine | Cardinal Health | ANDA | Current |
| 55154-8425 | Ketorolac Tromethamine | ketorolac tromethamine | Cardinal Health | ANDA | Current |
| 55154-8425 | Ketorolac Tromethamine | ketorolac tromethamine | Cardinal Health | ANDA | Current |
| 55154-8426 | Ketorolac Tromethamine | ketorolac tromethamine | Cardinal Health | ANDA | Current |
| 55154-8426 | Ketorolac Tromethamine | ketorolac tromethamine | Cardinal Health | ANDA | Current |
| 68071-4811 | Ketorolac Tromethamine | ketorolac tromethamine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4811 | Ketorolac Tromethamine | ketorolac tromethamine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68083-132 | ketorolac tromethamine | ketorolac tromethamine | Gland Pharma Limited | ANDA | Current |
| 68083-132 | ketorolac tromethamine | ketorolac tromethamine | Gland Pharma Limited | ANDA | Current |
| 68083-132 | ketorolac tromethamine | ketorolac tromethamine | Gland Pharma Limited | ANDA | Current |
| 68083-132 | ketorolac tromethamine | ketorolac tromethamine | Gland Pharma Limited | ANDA | Current |
| 68083-132 | ketorolac tromethamine | ketorolac tromethamine | Gland Pharma Limited | ANDA | Current |
| 68083-133 | ketorolac tromethamine | ketorolac tromethamine | Gland Pharma Limited | ANDA | Current |
| 68083-133 | ketorolac tromethamine | ketorolac tromethamine | Gland Pharma Limited | ANDA | Current |
| 68083-133 | ketorolac tromethamine | ketorolac tromethamine | Gland Pharma Limited | ANDA | Current |
| 68083-133 | ketorolac tromethamine | ketorolac tromethamine | Gland Pharma Limited | ANDA | Current |
| 68083-133 | ketorolac tromethamine | ketorolac tromethamine | Gland Pharma Limited | ANDA | Current |
| 68083-134 | ketorolac tromethamine | ketorolac tromethamine | Gland Pharma Limited | ANDA | Current |
| 68083-134 | ketorolac tromethamine | ketorolac tromethamine | Gland Pharma Limited | ANDA | Current |
| 68083-134 | ketorolac tromethamine | ketorolac tromethamine | Gland Pharma Limited | ANDA | Current |
| 68083-134 | ketorolac tromethamine | ketorolac tromethamine | Gland Pharma Limited | ANDA | Current |
| 68083-134 | ketorolac tromethamine | ketorolac tromethamine | Gland Pharma Limited | ANDA | Current |
| 70518-1159 | Ketorolac Tromethamine | ketorolac tromethamine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1669 | Ketorolac Tromethamine | ketorolac tromethamine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1889 | Ketorolac Tromethamine | ketorolac tromethamine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1889 | Ketorolac Tromethamine | ketorolac tromethamine | REMEDYREPACK INC. | ANDA | Current |
| 70518-2608 | Ketorolac Tromethamine | ketorolac tromethamine | REMEDYREPACK INC. | ANDA | Current |
| 70518-2610 | Ketorolac Tromethamine | ketorolac tromethamine | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 45796 | ORIG | 2016-11-03 |