Application 022427

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACUVAIL	KETOROLAC TROMETHAMINE	SOLUTION/DROPS;OPHTHALMIC	0.45%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N022427-001	ACUVAIL	KETOROLAC TROMETHAMINE	0.45%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2009-07-22

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N022427-001	8512717	2028-03-07	Drug product	2013-09-19
N022427-001	9192571	2028-03-07	Drug product	2015-12-21
N022427-001	7842714	2029-08-15	Drug substance, Drug product	2010-11-30

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 167 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N022427-001	8512717	2028-03-07	Drug product	2013-09-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022427-001	9192571	2028-03-07	Drug product	2015-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022427-001	7842714	2029-08-15	Drug substance, Drug product	2010-11-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022427-001	8512717	2028-03-07	Drug product	2013-09-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022427-001	9192571	2028-03-07	Drug product	2015-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022427-001	7842714	2029-08-15	Drug substance, Drug product	2010-11-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022427-001	8512717	2028-03-07	Drug product	2013-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022427-001	9192571	2028-03-07	Drug product	2015-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022427-001	7842714	2029-08-15	Drug substance, Drug product	2010-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022427-001	8512717	2028-03-07	Drug product	2013-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022427-001	9192571	2028-03-07	Drug product	2015-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022427-001	7842714	2029-08-15	Drug substance, Drug product	2010-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022427-001	8512717	2028-03-07	Drug product	2013-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022427-001	9192571	2028-03-07	Drug product	2015-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022427-001	7842714	2029-08-15	Drug substance, Drug product	2010-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022427-001	8512717	2028-03-07	Drug product	2013-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022427-001	9192571	2028-03-07	Drug product	2015-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022427-001	7842714	2029-08-15	Drug substance, Drug product	2010-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022427-001	8512717	2028-03-07	Drug product	2013-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022427-001	9192571	2028-03-07	Drug product	2015-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022427-001	7842714	2029-08-15	Drug substance, Drug product	2010-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022427-001	8512717	2028-03-07	Drug product	2013-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022427-001	9192571	2028-03-07	Drug product	2015-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022427-001	7842714	2029-08-15	Drug substance, Drug product	2010-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022427-001	8992952	2024-08-05	Drug product	2015-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022427-001	8512717	2028-03-07	Drug product	2013-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022427-001	9192571	2028-03-07	Drug product	2015-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022427-001	7842714	2029-08-15	Drug substance, Drug product	2010-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022427-001	8992952	2024-08-05	Drug product	2015-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022427-001	8512717	2028-03-07	Drug product	2013-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022427-001	9192571	2028-03-07	Drug product	2015-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022427-001	7842714	2029-08-15	Drug substance, Drug product	2010-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022427-001	8992952	2024-08-05	Drug product	2015-04-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022427-001	8512717	2028-03-07	Drug product	2013-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022427-001	9192571	2028-03-07	Drug product	2015-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022427-001	7842714	2029-08-15	Drug substance, Drug product	2010-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022427-001	8992952	2024-08-05	Drug product	2015-04-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022427-001	8512717	2028-03-07	Drug product	2013-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022427-001	9192571	2028-03-07	Drug product	2015-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022427-001	7842714	2029-08-15	Drug substance, Drug product	2010-11-30	`d8e5a09893c0…`

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
ACUVAIL	KETOROLAC TROMETHAMINE	Allergan, Inc.	3cea5803-a446-4d2c-9747-f3fb034332c8	2024-05-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022427 application number: NDA022427 ndc (product): 0023-3507

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-3507	ACUVAIL	ketorolac tromethamine	Allergan, Inc.	NDA	Current
0023-3507	ACUVAIL	ketorolac tromethamine	Allergan, Inc.	NDA	Current
0023-3507	ACUVAIL	ketorolac tromethamine	Allergan, Inc.	NDA	Current
0023-3507	ACUVAIL	ketorolac tromethamine	Allergan, Inc.	NDA	Current
0023-3507	ACUVAIL	ketorolac tromethamine	Allergan, Inc.	NDA	Current
0023-3507	ACUVAIL	ketorolac tromethamine	Allergan, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78558	SUPPL	2024-08-05
78562	SUPPL	2024-05-28
17581	SUPPL	2014-12-10
7382	SUPPL	2014-12-05
38701	SUPPL	2012-11-19
7381	SUPPL	2012-11-19
29723	SUPPL	2012-11-16
17580	SUPPL	2012-11-16
29722	SUPPL	2010-07-01
24304	ORIG	2010-01-21
22019	ORIG	2010-01-21
17579	ORIG	2009-08-14
7380	ORIG	2009-07-30