Application 078737

Type: ANDA
Sponsor: SUN PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	INJECTABLE;INJECTION	15MG/ML	No	No
002	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	INJECTABLE;INJECTION	30MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078737-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION			2008-10-06
A078737-002	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION			2008-10-06

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 3 · 82 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	A078737-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		2008-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078737-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION		2008-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078737-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		2008-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078737-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION		2008-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078737-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		2008-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078737-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION		2008-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078737-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2008-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078737-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2008-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078737-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2008-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078737-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2008-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078737-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2008-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078737-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2008-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078737-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2008-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078737-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2008-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078737-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2008-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078737-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2008-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078737-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2008-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078737-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2008-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078737-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2008-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078737-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2008-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078737-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2008-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078737-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2008-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078737-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2008-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078737-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2008-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078737-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2008-10-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078737-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2008-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078737-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2008-10-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078737-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2008-10-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078737-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		2008-10-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078737-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION		2008-10-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078737-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		2008-10-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078737-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION		2008-10-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078737-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		2008-10-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078737-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION		2008-10-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078737-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		2008-10-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078737-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION		2008-10-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078737-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		2008-10-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078737-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION		2008-10-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078737-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION		2008-10-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078737-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION		2008-10-06	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078737-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078737-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078737-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078737-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078737-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078737-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078737-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078737-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078737-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078737-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078737-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078737-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078737-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078737-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078737-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078737-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078737-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078737-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078737-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078737-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078737-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078737-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078737-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078737-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078737-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A078737-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078737-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A078737-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078737-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078737-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078737-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078737-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078737-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078737-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078737-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078737-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078737-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A078737-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078737-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A078737-002	AP	1	`3bdfa0b2c4d7…`

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
ketorolac tromethamine	KETOROLAC TROMETHAMINE	Sun Pharmaceutical Industries, Inc.	29a92a7c-68d1-489b-ba27-d788b3153795	2024-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078737 application number: ANDA078737 ndc (product): 47335-933 ndc (product): 47335-934 ndc (product): 47335-935

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47335-933	ketorolac tromethamine	ketorolac tromethamine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-934	ketorolac tromethamine	ketorolac tromethamine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-935	ketorolac tromethamine	ketorolac tromethamine	Sun Pharmaceutical Industries, Inc.	ANDA	Current