Application 021528

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACULAR LS	KETOROLAC TROMETHAMINE	SOLUTION/DROPS;OPHTHALMIC	0.4%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021528-001	ACULAR LS	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-05-30

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021528-001	8008338	2027-05-24	U-1181	Drug substance, Drug product	2011-09-23
N021528-001	8008338*PED	2027-11-24		Pediatric extension

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 · 42 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
2026-08-18 06:07:40	2026-07	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-05-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`e64feba35796…`

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	N021528-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021528-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021528-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021528-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021528-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021528-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021528-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021528-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021528-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021528-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021528-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021528-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021528-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021528-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021528-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021528-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021528-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021528-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021528-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021528-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021528-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021528-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021528-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021528-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021528-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021528-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021528-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021528-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021528-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021528-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021528-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021528-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021528-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021528-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021528-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021528-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021528-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021528-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021528-001	AT	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 434 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021528-001	8008338	2027-05-24	U-1181	Drug substance, Drug product	2011-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021528-001	8008338*PED	2027-11-24		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021528-001	8008338	2027-05-24	U-1181	Drug substance, Drug product	2011-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021528-001	8008338*PED	2027-11-24		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021528-001	8008338	2027-05-24	U-1181	Drug substance, Drug product	2011-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021528-001	8008338*PED	2027-11-24		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021528-001	8008338	2027-05-24	U-1181	Drug substance, Drug product	2011-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021528-001	8008338*PED	2027-11-24		Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021528-001	8008338	2027-05-24	U-1181	Drug substance, Drug product	2011-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021528-001	8008338*PED	2027-11-24		Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021528-001	8008338	2027-05-24	U-1181	Drug substance, Drug product	2011-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021528-001	8008338*PED	2027-11-24		Pediatric extension		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	8207215	2024-05-28	U-1251		2012-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	8377982	2024-05-28	U-1363		2013-03-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	8541463	2024-05-28	U-1441		2013-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	8648107	2024-05-28		Drug product	2014-03-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	8906950	2024-05-28	U-1626		2015-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	8946281	2024-05-28	U-1662		2015-03-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	9216167	2024-05-28	U-1800		2016-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	8207215*PED	2024-11-28		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	8377982*PED	2024-11-28		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	8541463*PED	2024-11-28		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	8008338	2027-05-24	U-1181	Drug substance, Drug product	2011-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	8008338*PED	2027-11-24		Pediatric extension		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021528-001	8207215	2024-05-28	U-1251		2012-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021528-001	8377982	2024-05-28	U-1363		2013-03-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021528-001	8541463	2024-05-28	U-1441		2013-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021528-001	8648107	2024-05-28		Drug product	2014-03-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021528-001	8906950	2024-05-28	U-1626		2015-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021528-001	8946281	2024-05-28	U-1662		2015-03-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021528-001	9216167	2024-05-28	U-1800		2016-01-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021528-001	8207215*PED	2024-11-28		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021528-001	8377982*PED	2024-11-28		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021528-001	8541463*PED	2024-11-28		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021528-001	8008338	2027-05-24	U-1181	Drug substance, Drug product	2011-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021528-001	8008338*PED	2027-11-24		Pediatric extension		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021528-001	8207215	2024-05-28	U-1251		2012-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021528-001	8377982	2024-05-28	U-1363		2013-03-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021528-001	8541463	2024-05-28	U-1441		2013-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021528-001	8648107	2024-05-28		Drug product	2014-03-04	`5bbf6a4d5a75…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACULAR LS	KETOROLAC TROMETHAMINE	Allergan, Inc.	4fad0873-f79c-4f07-9fac-5060be6b38fe	2024-06-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021528 application number: NDA021528 ndc (product): 0023-9277
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	Pacific Pharma, Inc.	8432a1c5-15e5-4e3d-8e2d-49646e6b7eda	2024-06-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021528 application number: NDA021528 ndc (product): 60758-773
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	A-S Medication Solutions	1580b751-15ff-4193-8f22-25a9a468989a	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021528 application number: NDA021528 ndc (product): 50090-3550

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-9277	ACULAR LS	Ketorolac Tromethamine	Allergan, Inc.	NDA	Current
0023-9277	ACULAR LS	Ketorolac Tromethamine	Allergan, Inc.	NDA	Current
0023-9277	ACULAR LS	Ketorolac Tromethamine	Allergan, Inc.	NDA	Current
0023-9277	ACULAR LS	Ketorolac Tromethamine	Allergan, Inc.	NDA	Current
0023-9277	ACULAR LS	Ketorolac Tromethamine	Allergan, Inc.	NDA	Current
50090-3550	KETOROLAC TROMETHAMINE	Ketorolac Tromethamine	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-3550	KETOROLAC TROMETHAMINE	Ketorolac Tromethamine	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-3550	KETOROLAC TROMETHAMINE	Ketorolac Tromethamine	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-3550	KETOROLAC TROMETHAMINE	Ketorolac Tromethamine	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
60758-773	KETOROLAC TROMETHAMINE	Ketorolac Tromethamine	Pacific Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
60758-773	KETOROLAC TROMETHAMINE	Ketorolac Tromethamine	Pacific Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
60758-773	KETOROLAC TROMETHAMINE	Ketorolac Tromethamine	Pacific Pharma, Inc.	NDA AUTHORIZED	Current
60758-773	KETOROLAC TROMETHAMINE	Ketorolac Tromethamine	Pacific Pharma, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66701	SUPPL	2021-03-09
66664	SUPPL	2021-03-09
15695	SUPPL	2016-06-01
5649	SUPPL	2008-12-04
42201	ORIG	2003-11-06
15694	ORIG	2003-06-08
5648	ORIG	2003-06-08