Application 019700

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACULAR	KETOROLAC TROMETHAMINE	SOLUTION/DROPS;OPHTHALMIC	0.5%	Yes	Yes

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
N019700-001	ACULAR	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019700-001	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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019700-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019700-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019700-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019700-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019700-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019700-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019700-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019700-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019700-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019700-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019700-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019700-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019700-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019700-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019700-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019700-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019700-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019700-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019700-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019700-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019700-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019700-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019700-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019700-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019700-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019700-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019700-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019700-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019700-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019700-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019700-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019700-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019700-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019700-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019700-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019700-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019700-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019700-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019700-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019700-001	AT	1	`cb3db0bc1861…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acular	KETOROLAC TROMETHAMINE	Allergan, Inc.	c94644d3-7b64-4f3d-a0c7-12c77466a0fc	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019700 application number: NDA019700 ndc (product): 0023-2181

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-2181	Acular	Ketorolac Tromethamine	Allergan, Inc.	NDA	Current
0023-2181	Acular	Ketorolac Tromethamine	Allergan, Inc.	NDA	Current
0023-2181	Acular	Ketorolac Tromethamine	Allergan, Inc.	NDA	Current
21695-463	ACULAR	KETOROLAC TROMETHAMINE	Rebel Distributors Corp.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83402	SUPPL	2025-09-19
83389	SUPPL	2025-09-19
11641	SUPPL	2012-06-18
1517	SUPPL	2012-06-18
20299	SUPPL	2009-01-12
33877	SUPPL	2005-03-11
19108	SUPPL	2005-03-11
11640	SUPPL	2005-03-11
1516	SUPPL	2005-03-11
11639	SUPPL	2003-06-16
33876	SUPPL	2002-02-08
19107	SUPPL	2002-02-08