Application 216759

Type: ANDA
Sponsor: BIONPHARMA

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
A216759-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		2023-02-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216759-001	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	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`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	A216759-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216759-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216759-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216759-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216759-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216759-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216759-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216759-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216759-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216759-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216759-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216759-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216759-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216759-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216759-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216759-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216759-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216759-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216759-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216759-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216759-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216759-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216759-001	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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	St. Mary's Medical Park Pharmacy	2d552135-bde5-5fe9-e063-6394a90af433	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216759 application number: ANDA216759
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Preferred Pharmaceuticals Inc.	337afb4f-789f-4cac-817a-e4286664a71e	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216759 application number: ANDA216759
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Direct_Rx	19fffe42-a02d-26eb-e063-6294a90aea5a	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216759 application number: ANDA216759
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	REMEDYREPACK INC.	04d5114e-332b-4ed0-85df-b276c1dc296c	2025-12-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216759 application number: ANDA216759
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Proficient Rx LP	38fc11a0-50d1-4ba5-8d46-331eb74a00d6	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216759 application number: ANDA216759
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Redpharm Drug	3b0aaf7f-c2fe-83c6-e063-6294a90a6f27	2025-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216759 application number: ANDA216759
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Bryant Ranch Prepack	8f36fde8-bc59-4a59-8659-b173cfd15774	2025-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216759 application number: ANDA216759
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Bionpharma Inc.	eda4b884-527c-42d3-971b-4d1678e5adbf	2025-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216759 application number: ANDA216759
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	18981677-8049-4864-b31c-96a299e3194d	2024-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216759 application number: ANDA216759