Application 203410

Type: ANDA
Sponsor: MICRO LABS LTD INDIA

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
A203410-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2019-04-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203410-001	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	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203410-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-05	`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	A203410-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203410-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203410-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203410-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203410-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203410-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203410-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203410-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203410-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203410-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203410-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203410-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203410-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203410-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203410-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203410-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203410-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203410-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203410-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203410-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203410-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203410-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203410-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203410-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203410-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203410-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203410-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203410-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203410-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203410-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203410-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203410-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203410-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203410-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203410-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203410-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203410-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203410-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203410-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203410-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Preferred Pharmaceuticals Inc.	92546f61-bbd8-430a-ac92-89dfbe8e2f29	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203410 application number: ANDA203410
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Micro Labs Limited	631c2c31-cd4f-4a17-85c6-be96746a753e	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203410 application number: ANDA203410 ndc (product): 42571-137
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	Direct Rx	d9a589b4-bd32-0e45-e053-2a95a90ae67d	2025-01-21		Exact identifier application applno (ANDA): 203410 application number: ANDA203410 ndc (product): 72189-335
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Bryant Ranch Prepack	8a495869-cbf7-4164-b3b2-6d4215edae6a	2024-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203410 application number: ANDA203410

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
42571-137	Ketorolac Tromethamine	Ketorolac Tromethamine	Micro Labs Limited	ANDA	Current
42571-137	Ketorolac Tromethamine	Ketorolac Tromethamine	Micro Labs Limited	ANDA	Current
68071-2576	Ketorolac Tromethamine	Ketorolac Tromethamine	NuCare Pharmaceuticals,Inc.	ANDA	Current
72189-335	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	Direct Rx	ANDA	Current