Application 215788

Type: ANDA
Sponsor: HAVIX

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 1.

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
A215788-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		2022-03-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A215788-001	AB

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.

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	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215788-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215788-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215788-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215788-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215788-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215788-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215788-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215788-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215788-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215788-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215788-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215788-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215788-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215788-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215788-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215788-001	AB	1	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215788-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215788-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215788-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215788-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215788-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215788-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215788-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215788-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215788-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215788-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215788-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215788-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215788-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215788-001	AB	1	`a50c72e98297…`

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 1 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Amerisyn LLC	5734e81e-2471-1314-e063-6294a90ac9fe	2026-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Major Pharmaceuticals	48245718-a2df-4938-8d06-3b8abf34181e	2026-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Northwind Health Company, LLC	08674066-7d4b-936d-e063-6394a90abbd7	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Redpharm Drug	37453bcd-e34b-5902-e063-6294a90a0245	2025-12-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788
ketorolac tromethamine	KETOROLAC TROMETHAMINE	Amici Pharma Inc.	8b26240c-b72b-42a6-ab33-a1e38224fbe0	2025-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Preferred Pharmaceuticals Inc.	18b450d2-e715-4710-a1d8-22b782f87f9c	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	0952d430-2665-4952-ba06-ab99f054f4df	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Bryant Ranch Prepack	afc691f8-517a-4d88-8322-87dafec8f064	2025-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Golden State Medical Supply, Inc.	ec6d453b-4b84-53d4-e053-2995a90a6006	2025-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788 ndc (product): 51407-677
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Ajanta Pharma USA Inc.	36713fb3-d301-432d-a95d-06e368fc8a22	2025-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Advanced Rx Pharmacy of Tennessee, LLC	f4e7f1c8-e458-0860-e053-2a95a90a1bf0	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	6fa20b41-f860-4fea-b1fb-ab6d3fa34a90	2024-11-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	DR. REDDY'S LABORATORIES, INC.	10827042-a2d4-44f9-837d-2023a3d552ff	2024-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788 ndc (product): 43598-139
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Bryant Ranch Prepack	9e5fde54-2206-4072-afb8-4d06a8d314b1	2023-11-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788 ndc (product): 71335-2136

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
43598-139	Ketorolac Tromethamine	ketorolac tromethamine	DR. REDDY'S LABORATORIES, INC.	ANDA	Current
51407-677	Ketorolac Tromethamine	ketorolac tromethamine	Golden State Medical Supply, Inc.	ANDA	Current
71335-2136	Ketorolac Tromethamine	ketorolac tromethamine	Bryant Ranch Prepack	ANDA	Current