Application 218204

Type: ANDA
Sponsor: CAPLIN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	SOLUTION/DROPS;OPHTHALMIC	0.5%	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
A218204-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2024-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218204-001	AT

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	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218204-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-03-26	`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	A218204-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218204-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218204-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218204-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218204-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218204-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218204-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218204-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218204-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218204-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218204-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218204-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218204-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A218204-001	AT	1	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218204-001	AT	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Redpharm Drug	53cb9528-7640-1fd4-e063-6294a90a74ad	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218204 application number: ANDA218204
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Redpharm Drug	49ade79d-4d23-6611-e063-6294a90adfaa	2026-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218204 application number: ANDA218204
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	SOLA Pharmaceuticals, LLC	b08a46f3-36c9-405d-a963-9739a5c87f9c	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218204 application number: ANDA218204
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Caplin Steriles Limited	4ba4a228-75d6-4a77-bf34-0381b2a89602	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218204 application number: ANDA218204
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	NuCare Pharmaceuticals, Inc.	2266e650-a0e9-027d-e063-6394a90a795d	2024-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218204 application number: ANDA218204
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Leading Pharma, LLC	c34b69c6-5cdf-41f6-8652-33bd8e9c6c70	2024-05-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218204 application number: ANDA218204