Application 214456

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214456-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP		2022-11-02
A214456-002	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP		2022-11-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A214456-001	AP
A214456-002	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.

Product history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`a67488948f0b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214456-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214456-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214456-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214456-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214456-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214456-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214456-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214456-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214456-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214456-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214456-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214456-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214456-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214456-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214456-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214456-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214456-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214456-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214456-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214456-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214456-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214456-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214456-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214456-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214456-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214456-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214456-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214456-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214456-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214456-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214456-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214456-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214456-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214456-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214456-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214456-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214456-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214456-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214456-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214456-002	AP	1	`a67488948f0b…`

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.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Sportpharm LLC	3efb4f4e-b849-3bb5-e063-6394a90a5305	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214456 application number: ANDA214456
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	Baxter Healthcare Corporation	30a3ca20-8f98-478c-8a6b-aa617f0a17a3	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214456 application number: ANDA214456
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	3321b610-1c9b-4314-adbb-a2e163234dec	2025-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214456 application number: ANDA214456
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Medical Purchasing Solutions, LLC	2900e69d-29ec-210a-e063-6294a90a5008	2024-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214456 application number: ANDA214456
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Medical Purchasing Solutions, LLC	29003279-8f27-bcdc-e063-6394a90aa639	2024-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214456 application number: ANDA214456
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Alembic Pharmaceuticals Inc.	419cf756-3c96-4bb8-ae96-6aea5a5f3afd	2024-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214456 application number: ANDA214456 ndc (product): 62332-599 ndc (product): 62332-600 ndc (product): 62332-601
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	e0065781-ea33-4662-a8b1-c936e937ac9f	2023-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214456 application number: ANDA214456

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62332-599	Ketorolac Tromethamine	Ketorolac Tromethamine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-599	Ketorolac Tromethamine	Ketorolac Tromethamine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-600	Ketorolac Tromethamine	Ketorolac Tromethamine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-600	Ketorolac Tromethamine	Ketorolac Tromethamine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-601	Ketorolac Tromethamine	Ketorolac Tromethamine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-601	Ketorolac Tromethamine	Ketorolac Tromethamine	Alembic Pharmaceuticals Inc.	ANDA	Current