Application 076109

Type: ANDA
Sponsor: APOTEX INC

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
A076109-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2009-11-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076109-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`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	A076109-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076109-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076109-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076109-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076109-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076109-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076109-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076109-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076109-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076109-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076109-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076109-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076109-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076109-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076109-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076109-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076109-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076109-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076109-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076109-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076109-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076109-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076109-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076109-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076109-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076109-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076109-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076109-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076109-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076109-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076109-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076109-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076109-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076109-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076109-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076109-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076109-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076109-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076109-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076109-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Apotex Corp.	d9a186ba-74a9-b6d4-1109-1e045ba1763e	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076109 application number: ANDA076109 ndc (product): 60505-1003
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	NuCare Pharmaceuticals, Inc.	3b3cc67c-e1ff-3a0a-e063-6394a90adb9a	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076109 application number: ANDA076109
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Proficient Rx LP	2f27e304-7a96-47b6-8ef1-8a649c25abcf	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076109 application number: ANDA076109 ndc (product): 63187-777

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45865-613	Ketorolac Tromethamine	ketorolac tromethamine	Medsource Pharmaceuticals	ANDA	Current
50090-2762	Ketorolac Tromethamine	ketorolac tromethamine	A-S Medication Solutions	ANDA	Current
50090-2762	Ketorolac Tromethamine	ketorolac tromethamine	A-S Medication Solutions	ANDA	Current
50090-2762	Ketorolac Tromethamine	ketorolac tromethamine	A-S Medication Solutions	ANDA	Current
60505-1003	Ketorolac Tromethamine	ketorolac tromethamine	Apotex Corp.	ANDA	Current
60505-1003	Ketorolac Tromethamine	ketorolac tromethamine	Apotex Corp.	ANDA	Current
60505-1003	Ketorolac Tromethamine	ketorolac tromethamine	Apotex Corp.	ANDA	Current
63187-777	Ketorolac Tromethamine	ketorolac tromethamine	Proficient Rx LP	ANDA	Current
63187-777	Ketorolac Tromethamine	ketorolac tromethamine	Proficient Rx LP	ANDA	Current
63187-777	Ketorolac Tromethamine	ketorolac tromethamine	Proficient Rx LP	ANDA	Current
68788-7384	Ketorolac Tromethamine	ketorolac tromethamine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7384	Ketorolac Tromethamine	ketorolac tromethamine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7384	Ketorolac Tromethamine	ketorolac tromethamine	Preferred Pharmaceuticals Inc.	ANDA	Current
72189-054	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	DIRECT RX	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8866	ORIG	2009-11-09