Application 074802
- Type
- ANDA
- Sponsor
- HOSPIRA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 15MG/ML | No | Yes |
| 002 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 30MG/ML | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074802-001 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 |
| A074802-002 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A074802-001 | AP |
| A074802-002 | 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 | A074802-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A074802-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074802-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074802-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A074802-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A074802-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074802-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074802-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074802-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074802-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074802-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074802-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074802-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074802-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074802-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074802-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074802-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074802-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A074802-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A074802-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074802-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074802-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074802-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074802-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074802-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074802-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A074802-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A074802-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074802-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074802-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A074802-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A074802-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A074802-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A074802-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A074802-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A074802-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A074802-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A074802-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A074802-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A074802-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-06-05 | 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 | A074802-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A074802-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074802-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074802-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A074802-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A074802-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074802-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074802-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074802-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074802-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074802-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074802-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074802-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074802-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074802-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074802-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074802-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074802-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A074802-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A074802-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074802-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074802-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074802-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074802-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074802-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074802-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A074802-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A074802-002 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074802-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074802-002 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A074802-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A074802-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A074802-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A074802-002 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A074802-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A074802-002 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A074802-001 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A074802-002 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A074802-001 | AP | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A074802-002 | 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 | Hospira, Inc. | 8accbb78-fc64-45d5-69b0-35c23a1d2a2e | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | 074802 ANDA074802 0409-3796 0409-3795 0409-3793 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health 107, LLC | dd489c86-08c0-4457-86f3-c4f36a70276c | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | 074802 ANDA074802 55154-6960 55154-0120 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health 107, LLC | f0cd5dfa-7eba-449f-a54a-a5155024a77e | 2026-05-12 | Boxed warning, Warnings, Adverse reactions | 074802 ANDA074802 |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | HF Acquisition Co LLC, DBA HealthFirst | 3d746288-681a-5232-e063-6394a90afabd | 2025-08-28 | Boxed warning, Warnings, Adverse reactions | 074802 ANDA074802 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Asclemed USA, Inc. | 004588ba-e109-4a53-9c9d-a42dea9bb848 | 2022-10-12 | Boxed warning, Warnings, Adverse reactions | 074802 ANDA074802 76420-184 |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | HF Acquisition Co LLC, DBA HealthFirst | 76446045-3cca-0206-e053-2a91aa0a2440 | 2020-09-04 | Boxed warning, Warnings, Adverse reactions | 074802 ANDA074802 51662-1292 51662-1295 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-3793 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3793 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3793 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3793 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3793 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3793 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3793 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3793 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3793 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3793 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3793 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3795 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3795 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3795 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3795 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3795 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3795 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3795 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3795 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3795 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3795 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3795 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3796 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3796 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3796 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3796 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3796 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3796 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3796 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3796 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3796 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3796 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 0409-3796 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | ANDA | Current |
| 50090-1328 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | A-S Medication Solutions | ANDA | Current |
| 50090-1521 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | A-S Medication Solutions | ANDA | Current |
| 51662-1292 | KETOROLAC TROMETHAM | KETOROLAC TROMETHAM | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1292 | KETOROLAC TROMETHAM | KETOROLAC TROMETHAM | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1292 | KETOROLAC TROMETHAM | KETOROLAC TROMETHAM | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1292 | KETOROLAC TROMETHAM | KETOROLAC TROMETHAM | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1292 | KETOROLAC TROMETHAM | KETOROLAC TROMETHAM | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1292 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1292 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1295 | KETOROLAC TROMETHAM | KETOROLAC TROMETHAM | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1295 | KETOROLAC TROMETHAM | KETOROLAC TROMETHAM | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1295 | KETOROLAC TROMETHAM | KETOROLAC TROMETHAM | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1295 | KETOROLAC TROMETHAM | KETOROLAC TROMETHAM | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1295 | KETOROLAC TROMETHAM | KETOROLAC TROMETHAM | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1295 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1295 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 52584-795 | Ketorolac Tromethamine | Ketorolac Tromethamine | General Injectables & Vaccines, Inc | ANDA | Current |
| 53225-3655 | ReadySharp Ketorolac | KETOROLAC TROMETHAMINE | Terrain Pharmaceuticals | ANDA | Current |
| 53225-3655 | ReadySharp Ketorolac | KETOROLAC TROMETHAMINE | Terrain Pharmaceuticals | ANDA | Current |
| 55154-0120 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health | ANDA | Current |
| 55154-0120 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health | ANDA | Current |
| 55154-0120 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health | ANDA | Current |
| 55154-0120 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health | ANDA | Current |
| 55154-0120 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health | ANDA | Current |
| 55154-0149 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health | ANDA | Current |
| 55154-6960 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health | ANDA | Current |
| 55154-6960 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health | ANDA | Current |
| 55154-6960 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health | ANDA | Current |
| 55154-6960 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health | ANDA | Current |
| 55154-6960 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health | ANDA | Current |
| 68071-1785 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1787 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1787 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7439 | ReadySharp Ketorolac | KETOROLAC TROMETHAMINE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-1074 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1074 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1074 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | REMEDYREPACK INC. | ANDA | Current |
| 71872-7022 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Medical Purchasing Solutions, LLC | ANDA | Current |
| 71872-7022 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Medical Purchasing Solutions, LLC | ANDA | Current |
| 71872-7188 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Medical Purchasing Solutions, LLC | ANDA | Current |
| 76420-184 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Asclemed USA, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 18367 | SUPPL | 2015-07-23 |