Application 075284

Type: ANDA
Sponsor: PLIVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075284-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL			1999-06-23

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 · 43 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
2026-09-14 22:38:34	2026-08	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	1999-06-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	1999-06-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	1999-06-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	1999-06-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075284-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL		1999-06-23	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075284-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075284-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075284-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075284-001	AB	1	`ea99ee380514…`

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 2 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	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
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Direct_rx	22de8e1c-5e68-fd78-e063-6394a90ad40b	2026-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	NuCare Pharmaceuticals,Inc.	c2290fd1-2985-1275-e053-2995a90ad5fa	2026-03-13	Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Direct_Rx	19fffe42-a02d-26eb-e063-6294a90aea5a	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Aurobindo Pharma Limited	007a4da5-d794-416c-94b3-6ee9e7842c52	2026-02-26	Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Major Pharmaceuticals	48245718-a2df-4938-8d06-3b8abf34181e	2026-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
ketorolac tromethamine	KETOROLAC TROMETHAMINE	Bryant Ranch Prepack	23e7b5f7-ea0d-468d-9d13-a95f9bf605c6	2026-02-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ketorolac tromethamine generic name: KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	Baxter Healthcare Corporation	30a3ca20-8f98-478c-8a6b-aa617f0a17a3	2026-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: KETOROLAC TROMETHAMINE generic name: KETOROLAC TROMETHAMINE
ketorolac tromethamine	KETOROLAC TROMETHAMINE	REMEDYREPACK INC.	43d07956-90ba-4e96-b265-aec03eced19b	2026-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ketorolac tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Civica, Inc.	32198544-4a46-495c-ab65-0836dcbc2c49	2026-02-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Redpharm Drug	49ade79d-4d23-6611-e063-6294a90adfaa	2026-01-31	Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Toronova II SUIK	KETOROLAC TROMETHAMINE	Advanced Rx of Tennessee, LLC	49dd153c-10e8-505b-e063-6394a90a595f	2026-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	GLENMARK PHARMACEUTICALS INC., USA	ce992bee-a9f5-48bd-a00e-513f590d69f2	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: KETOROLAC TROMETHAMINE generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Nephron Pharmaceuticals Corporation	ae6c60c0-e88a-45b2-e053-2995a90ac62f	2026-01-08	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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42973	ORIG	2005-07-22
30832	ORIG	1999-06-23