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 5 of 8 · 145 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	9fdba2e6-969f-4624-b08b-a42f99e4eff9	2025-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Advanced Rx of Tennessee, LLC	2cf7516b-ac86-ca72-e063-6394a90a4339	2025-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Caplin Steriles Limited	4ba4a228-75d6-4a77-bf34-0381b2a89602	2025-01-23	Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	Direct Rx	d9a589b4-bd32-0e45-e053-2a95a90ae67d	2025-01-21		Name fallback brand name: KETOROLAC TROMETHAMINE generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Advanced Rx Pharmacy of Tennessee, LLC	c1717245-cef3-b3d7-e053-2a95a90a1ac5	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Advanced Rx Pharmacy of Tennessee, LLC	f4e7f1c8-e458-0860-e053-2a95a90a1bf0	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Teva Pharmaceuticals USA, Inc.	688f5dec-a6db-43c6-a1f8-5df99d08d395	2024-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Medical Purchasing Solutions, LLC	2900e69d-29ec-210a-e063-6294a90a5008	2024-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Medical Purchasing Solutions, LLC	29003279-8f27-bcdc-e063-6394a90aa639	2024-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Toronova SUIK	KETOROLAC TROMETHAMINE	Advanced Rx of Tennessee, LLC	275f9131-5915-a585-e063-6294a90ab0fc	2024-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: KETOROLAC TROMETHAMINE
Sprix	KETOROLAC TROMETHAMINE	Zyla Life Sciences US LLC	97005a1c-167e-4676-bae7-e49b38c36f9e	2024-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	6fa20b41-f860-4fea-b1fb-ab6d3fa34a90	2024-11-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Civica, Inc.	1e8ddf13-c513-4e16-a91a-9d55726d9071	2024-11-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Bryant Ranch Prepack	8a495869-cbf7-4164-b3b2-6d4215edae6a	2024-11-04	Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	18981677-8049-4864-b31c-96a299e3194d	2024-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	Camber Pharmaceuticals, Inc.	478aff0b-29fd-43b2-a701-5236b8f8e3df	2024-10-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: KETOROLAC TROMETHAMINE generic name: KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	Caplin Steriles Limited	588b4804-4ac5-4b96-947e-354029ea4df9	2024-10-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: KETOROLAC TROMETHAMINE generic name: KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	Baxter Healthcare Corporation	4b58836d-9d58-4539-9691-9e11c505ef2a	2024-09-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: KETOROLAC TROMETHAMINE generic name: KETOROLAC TROMETHAMINE
ketorolac tromethamine	KETOROLAC TROMETHAMINE	FOSUN PHARMA USA INC	1aae6a4d-0909-4672-aa26-e3f2d8c4d413	2024-09-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ketorolac tromethamine generic name: KETOROLAC TROMETHAMINE
ketorolac tromethamine	KETOROLAC TROMETHAMINE	Gland Pharma Limited	5abd4389-4fb2-408b-a27e-cf64b6a921f1	2024-09-20	Boxed warning, 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