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 4 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	Micro Labs Limited	631c2c31-cd4f-4a17-85c6-be96746a753e	2025-09-29	Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Preferred Pharmaceuticals Inc.	18b450d2-e715-4710-a1d8-22b782f87f9c	2025-09-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	ProPharma Distribution	3f2956d9-9e68-f35e-e063-6394a90a706d	2025-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Acular	KETOROLAC TROMETHAMINE	Allergan, Inc.	c94644d3-7b64-4f3d-a0c7-12c77466a0fc	2025-09-18	Warnings, Adverse reactions	Name fallback generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	American Health Packaging	48244614-53ec-47e6-ad48-50814bdcceb7	2025-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	HF Acquisition Co LLC, DBA HealthFirst	3d746288-681a-5232-e063-6394a90afabd	2025-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: KETOROLAC TROMETHAMINE generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	0952d430-2665-4952-ba06-ab99f054f4df	2025-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	NuCare Pharmaceuticals, Inc.	3b3cc67c-e1ff-3a0a-e063-6394a90adb9a	2025-07-31	Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Redpharm Drug	3b0aaf7f-c2fe-83c6-e063-6294a90a6f27	2025-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	PD-Rx Pharmaceuticals, Inc.	862dd7b7-8ed5-42bf-870e-a45b86740226	2025-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: KETOROLAC TROMETHAMINE generic name: KETOROLAC TROMETHAMINE
Ketorolac tromethamine	KETOROLAC TROMETHAMINE	Henry Schein, Inc.	99c06dde-f218-4d81-91e0-f37a748872d6	2025-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Bryant Ranch Prepack	afc691f8-517a-4d88-8322-87dafec8f064	2025-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Henry Schein, Inc.	1e65d11b-5aa9-4a6b-b5d6-c19828748fea	2025-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac tromethamine	KETOROLAC TROMETHAMINE	Henry Schein, Inc.	606b0f2f-de28-42a9-96f4-cacba2c7c56a	2025-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Bryant Ranch Prepack	8f36fde8-bc59-4a59-8659-b173cfd15774	2025-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
ketorolac tromethamine	KETOROLAC TROMETHAMINE	NuCare Pharmaceuticals,Inc.	fe7eb195-48be-753b-e053-6294a90a8500	2025-04-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ketorolac tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	PD-Rx Pharmaceuticals, Inc.	add10ccd-c205-4512-9619-253290fa1152	2025-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Bionpharma Inc.	eda4b884-527c-42d3-971b-4d1678e5adbf	2025-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Golden State Medical Supply, Inc.	ec6d453b-4b84-53d4-e053-2995a90a6006	2025-02-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Ajanta Pharma USA Inc.	36713fb3-d301-432d-a95d-06e368fc8a22	2025-02-13	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