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 3 of 8 · 145 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Toronova SUIK	KETOROLAC TROMETHAMINE	Asclemed USA, Inc.	e0ed6947-5520-403b-bc0e-1caa95ab3302	2026-01-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Northwind Health Company, LLC	08674066-7d4b-936d-e063-6394a90abbd7	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Northwind Health Company, LLC	d17ed469-677b-4a2e-96a9-5cfd0f50ecd9	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
ketorolac tromethamine	KETOROLAC TROMETHAMINE	ProPharma Distribution	42dfd39e-53a3-e9ee-e063-6394a90ab51e	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ketorolac tromethamine generic name: KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	Medical Purchasing Solutions, LLC	46434a32-b727-0c5b-e063-6394a90a0c48	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: KETOROLAC TROMETHAMINE generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Redpharm Drug	37453bcd-e34b-5902-e063-6294a90a0245	2025-12-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
ketorolac tromethamine	KETOROLAC TROMETHAMINE	Amici Pharma Inc.	8b26240c-b72b-42a6-ab33-a1e38224fbe0	2025-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ketorolac tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	SOLA Pharmaceuticals, LLC	2301a6a2-b88a-4c0d-bb6c-ad4a8af7da39	2025-12-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	SOLA Pharmaceuticals, LLC	b08a46f3-36c9-405d-a963-9739a5c87f9c	2025-12-08	Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Chartwell RX, LLC	3855f527-fd6c-4f24-a4b4-cd47eec1193d	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
ketorolac tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	d8e928ac-c1e7-4b7a-87cd-9d11e36d53c0	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ketorolac tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	3321b610-1c9b-4314-adbb-a2e163234dec	2025-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	5e42914f-de71-4176-819b-9fa26a8bdce6	2025-11-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac tromethamine generic name: KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	Sandoz Inc	79e29a86-1b44-4d95-8d84-5a2e8f23ddcf	2025-10-27	Warnings, Adverse reactions	Name fallback brand name: KETOROLAC TROMETHAMINE generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Sagent Pharmaceuticals	62591551-a644-4b2c-a0de-982e906fabc3	2025-10-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Cardinal Health 107, LLC	63b73913-246d-4e5b-bdc9-c202980d8777	2025-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	49e04373-568d-48fa-ac1c-b7d6b493e777	2025-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Proficient Rx LP	38fc11a0-50d1-4ba5-8d46-331eb74a00d6	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	Onesource Specialty Pharma Limited	4596483b-990b-eaa4-e063-6394a90ac08f	2025-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: KETOROLAC TROMETHAMINE generic name: KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	Onesource Specialty Pharma Limited	45966992-5af6-bf10-e063-6294a90af25b	2025-09-30	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.

Documents#

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