Application 074993

Type: ANDA
Sponsor: HOSPIRA

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
A074993-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION			1999-01-27
A074993-002	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION			1999-01-27

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 · 82 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	A074993-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		1999-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074993-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION		1999-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074993-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		1999-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074993-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION		1999-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074993-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		1999-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074993-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION		1999-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074993-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		1999-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074993-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	1999-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074993-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		1999-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074993-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	1999-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074993-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		1999-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074993-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	1999-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074993-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		1999-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074993-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	1999-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074993-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		1999-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074993-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	1999-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074993-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		1999-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074993-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	1999-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074993-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		1999-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074993-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	1999-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074993-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		1999-01-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074993-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	1999-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074993-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		1999-01-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074993-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	1999-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074993-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		1999-01-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074993-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	1999-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074993-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		1999-01-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074993-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	1999-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074993-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		1999-01-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074993-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	1999-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074993-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		1999-01-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074993-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	1999-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074993-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		1999-01-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074993-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	1999-01-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074993-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	1999-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074993-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	1999-01-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074993-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		1999-01-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074993-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	1999-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074993-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		1999-01-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074993-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	1999-01-27	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074993-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074993-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074993-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074993-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074993-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074993-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074993-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074993-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074993-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074993-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074993-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074993-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074993-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074993-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074993-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074993-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074993-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074993-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074993-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074993-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A074993-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074993-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A074993-002	AP	1	`8869cabd3fbd…`
2019-12-14 00:12 UTC	2019-12	A074993-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074993-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074993-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074993-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074993-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074993-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074993-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074993-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074993-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074993-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074993-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074993-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074993-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074993-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074993-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074993-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074993-002	AP	1	`f41ea6bd6efb…`

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 8 · 145 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ketorolac tromethamine	KETOROLAC TROMETHAMINE	REMEDYREPACK INC.	b0aa1137-d0c3-4e4e-b1ec-5fe4b24e570a	2026-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ketorolac tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Amerisyn LLC	5734e81e-2471-1314-e063-6294a90ac9fe	2026-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Hospira, Inc.	8accbb78-fc64-45d5-69b0-35c23a1d2a2e	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Apotex Corp.	d9a186ba-74a9-b6d4-1109-1e045ba1763e	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	HF Acquisition Co LLC, DBA HealthFirst	e46ebc7f-584e-e2b7-e053-2995a90ad17b	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: KETOROLAC TROMETHAMINE generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	St. Mary's Medical Park Pharmacy	2d552135-bde5-5fe9-e063-6394a90af433	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	REMEDYREPACK INC.	f47d4365-40a8-445b-99cd-49edad6a8ffc	2026-06-22	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	54dec321-b4c9-f0d6-e063-6294a90ae231	2026-06-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: KETOROLAC TROMETHAMINE generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Cardinal Health 107, LLC	dd489c86-08c0-4457-86f3-c4f36a70276c	2026-06-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Injecta Medcial LLC	515464a7-16c5-2811-e063-6294a90aa451	2026-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
ketorolac tromethamine	KETOROLAC TROMETHAMINE	Preferred Pharmaceuticals Inc.	1e7ae5af-76b9-49a9-ba14-52b566929c22	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ketorolac tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Redpharm Drug	53cb9528-7640-1fd4-e063-6294a90a74ad	2026-06-09	Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
ketorolac tromethamine	KETOROLAC TROMETHAMINE	REMEDYREPACK INC.	26a1761b-90bf-49c6-9e6a-f293af2296ce	2026-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ketorolac tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Cardinal Health 107, LLC	f335a030-ffa8-4f42-8166-2f06e036b40d	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Injecta Medcial LLC	521b3d09-df08-fcae-e063-6294a90a6545	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Preferred Pharmaceuticals Inc.	92546f61-bbd8-430a-ac92-89dfbe8e2f29	2026-05-15	Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
ketorolac tromethamine	KETOROLAC TROMETHAMINE	Redpharm Drug	51d443f8-716d-af3a-e063-6394a90a56a3	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ketorolac tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Preferred Pharmaceuticals Inc.	337afb4f-789f-4cac-817a-e4286664a71e	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Cardinal Health 107, LLC	f0cd5dfa-7eba-449f-a54a-a5155024a77e	2026-05-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Sportpharm LLC	3efb4f4e-b849-3bb5-e063-6394a90a5305	2026-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-2287	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Hospira, Inc.	ANDA	Current
0409-2287	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Hospira, Inc.	ANDA	Current
0409-2287	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Hospira, Inc.	ANDA	Current
0409-2287	Ketorolac Tromethamine	Ketorolac Tromethamine	Hospira, Inc.	ANDA	Current
0409-2287	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Hospira, Inc.	ANDA	Current
0409-2287	Ketorolac Tromethamine	Ketorolac Tromethamine	Hospira, Inc.	ANDA	Current
0409-2287	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Hospira, Inc.	ANDA	Current
0409-2287	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Hospira, Inc.	ANDA	Current
0409-2287	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Hospira, Inc.	ANDA	Current
0409-2287	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Hospira, Inc.	ANDA	Current
21695-588	Ketorolac Tromethamine	Ketorolac Tromethamine	Rebel Distributors Corp	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8483	ORIG	1997-01-27