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 6 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	NuCare Pharmaceuticals, Inc.	2266e650-a0e9-027d-e063-6394a90a795d	2024-09-18	Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Mylan Pharmaceuticals Inc.	2837a082-3a34-6f81-5e43-45a70295686b	2024-08-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Aurobindo Pharma Limited	e93f6501-827d-474c-b660-765b7c0fb871	2024-08-26	Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	NuCare Pharmaceuticals, Inc.	415a5393-296f-30e3-e054-00144ff8d46c	2024-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	NuCare Pharmaceuticals, Inc.	46dc8f62-e754-50e3-e054-00144ff8d46c	2024-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
ketorolac tromethamine	KETOROLAC TROMETHAMINE	Zydus Lifesciences Limited	5a4192e8-d9e5-4f09-99f6-da5a648b1aac	2024-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ketorolac tromethamine generic name: KETOROLAC TROMETHAMINE
ketorolac tromethamine	KETOROLAC TROMETHAMINE	Zydus Pharmaceuticals (USA) Inc.	ffd84ef3-26ed-4810-952b-4f0e913c5e32	2024-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ketorolac tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	DR. REDDY'S LABORATORIES, INC.	10827042-a2d4-44f9-837d-2023a3d552ff	2024-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
ketorolac tromethamine	KETOROLAC TROMETHAMINE	Sun Pharmaceutical Industries, Inc.	29a92a7c-68d1-489b-ba27-d788b3153795	2024-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ketorolac tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	d1920335-8e45-4960-b6e9-e6f1f9e6820c	2024-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	Eugia US LLC	f520978f-9046-4ff8-b04d-0f615fdeae4d	2024-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: KETOROLAC TROMETHAMINE generic name: KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	NuCare Pharmaceuticals,Inc.	ae2e626c-0019-7c4e-e053-2995a90a23be	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: KETOROLAC TROMETHAMINE generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Alembic Pharmaceuticals Inc.	419cf756-3c96-4bb8-ae96-6aea5a5f3afd	2024-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
ACULAR LS	KETOROLAC TROMETHAMINE	Allergan, Inc.	4fad0873-f79c-4f07-9fac-5060be6b38fe	2024-06-21	Warnings, Adverse reactions	Name fallback generic name: KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	Pacific Pharma, Inc.	8432a1c5-15e5-4e3d-8e2d-49646e6b7eda	2024-06-21	Warnings, Adverse reactions	Name fallback brand name: KETOROLAC TROMETHAMINE generic name: KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	A-S Medication Solutions	1580b751-15ff-4193-8f22-25a9a468989a	2024-06-10	Warnings, Adverse reactions	Name fallback brand name: KETOROLAC TROMETHAMINE generic name: KETOROLAC TROMETHAMINE
ACUVAIL	KETOROLAC TROMETHAMINE	Allergan, Inc.	3cea5803-a446-4d2c-9747-f3fb034332c8	2024-05-31	Warnings, Adverse reactions	Name fallback generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Leading Pharma, LLC	c34b69c6-5cdf-41f6-8652-33bd8e9c6c70	2024-05-24	Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Hikma Pharmaceuticals USA Inc.	0c2c75c9-ed7b-46a8-9543-429bf2d8f090	2024-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketorolac Tromethamine generic name: KETOROLAC TROMETHAMINE
ketorolac tromethamine	KETOROLAC TROMETHAMINE	NuCare Pharmaceuticals,Inc.	155c9171-d394-9c28-e063-6394a90a8209	2024-04-05	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