Application 078145

Type: ANDA
Sponsor: LUITPOLD

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 43.

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
A078145-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION			2008-01-14
A078145-002	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION			2008-01-14

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078145-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	2008-01-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078145-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	2008-01-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078145-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	2008-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078145-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	2008-01-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078145-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	2008-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078145-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	2008-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078145-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	2008-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078145-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	2008-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078145-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	2008-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078145-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	2008-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078145-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	2008-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078145-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	2008-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078145-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	2008-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078145-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	2008-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078145-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	2008-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078145-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	2008-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078145-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	2008-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078145-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	2008-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078145-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	2008-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078145-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	2008-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078145-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	2008-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078145-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	2008-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078145-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	2008-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078145-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	2008-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078145-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	2008-01-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078145-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	2008-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078145-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	2008-01-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078145-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	2008-01-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078145-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	2008-01-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078145-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	2008-01-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078145-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	2008-01-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078145-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	2008-01-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078145-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	2008-01-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078145-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	2008-01-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078145-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	2008-01-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078145-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	2008-01-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078145-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	2008-01-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078145-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	2008-01-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078145-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	2008-01-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078145-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	2008-01-14	`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.

Matched openFDA labels page 7 of 8 · 145 matching rows.

Brand, Generic, Manufacturer table
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	Name fallback generic name: KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	Leading Pharma, LLC	04df9620-6dcb-494a-83e2-6d28036be974	2024-02-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: KETOROLAC TROMETHAMINE generic name: KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	A-S Medication Solutions	a1ebb51e-4658-4852-bf90-1983a3d44783	2023-12-10	Warnings, Adverse reactions	Name fallback brand name: KETOROLAC TROMETHAMINE generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Bryant Ranch Prepack	f713500a-20b8-8e20-c4cc-956805170335	2023-11-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Bryant Ranch Prepack	9e5fde54-2206-4072-afb8-4d06a8d314b1	2023-11-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	e0065781-ea33-4662-a8b1-c936e937ac9f	2023-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Asclemed USA, Inc.	94c7c57a-fd1e-41ab-bc39-9a538f6011d1	2023-09-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	3d88cbe6-5230-47aa-80af-0c41283d1f00	2023-08-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Medical Purchasing Solutions, LLC	9e3ddc51-b572-8fe9-e053-2995a90a2f2a	2023-05-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac tromethamine	KETOROLAC TROMETHAMINE	Medical Purchasing Solutions, LLC	ada639d4-babb-2ad0-e053-2a95a90afce7	2023-05-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac tromethamine	KETOROLAC TROMETHAMINE	Medical Purchasing Solutions, LLC	e17f583d-8bd4-3ed0-e053-2a95a90a9090	2023-04-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	b88e562d-226b-4200-afa5-034e628c660f	2023-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	950b7295-3f68-4027-ac2b-2f7d0f5f8ef9	2022-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	ATNAHS PHARMA US LIMITED	57ea681c-392e-4f41-a374-91ed20473161	2022-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: KETOROLAC TROMETHAMINE generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Proficient Rx LP	2f27e304-7a96-47b6-8ef1-8a649c25abcf	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Camber Pharmaceuticals, Inc.	e1fb8753-4695-4cb2-83d7-15d79fbaeeb2	2022-10-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Asclemed USA, Inc.	004588ba-e109-4a53-9c9d-a42dea9bb848	2022-10-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	ccf905ca-e164-4779-9485-2d139c821bad	2022-09-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac tromethamine	KETOROLAC TROMETHAMINE	Asclemed USA, Inc.	ee44c322-4b4b-4397-a1a5-e5b3c3c5a053	2022-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac tromethamine generic name: KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	Proficient Rx LP	c4598ce4-41fb-4cc9-8102-3a66a9bfa36a	2022-08-01	Warnings, Adverse reactions	Name fallback brand name: KETOROLAC TROMETHAMINE generic name: KETOROLAC TROMETHAMINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0517-0601	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	American Regent, Inc.	ANDA	Current
0517-0801	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	American Regent, Inc.	ANDA	Current
0517-0902	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	American Regent, Inc.	ANDA	Current