Application 075772

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

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
003	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	INJECTABLE; INJECTION	60MG/2ML	No	No

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

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
A075772-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP		2004-07-21
A075772-002	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP		2004-07-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075772-001	AP
A075772-002	AP

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 · 84 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
2026-08-18 06:07:40	2026-07	A075772-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075772-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075772-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075772-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075772-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075772-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075772-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075772-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075772-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075772-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075772-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075772-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075772-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075772-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075772-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075772-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075772-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075772-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075772-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075772-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075772-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075772-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075772-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075772-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075772-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075772-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075772-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075772-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075772-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075772-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075772-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075772-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075772-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075772-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075772-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075772-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075772-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075772-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075772-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075772-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2004-07-21	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075772-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075772-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075772-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075772-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075772-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075772-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075772-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075772-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075772-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075772-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075772-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075772-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075772-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075772-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075772-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075772-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075772-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075772-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075772-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075772-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075772-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075772-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075772-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075772-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075772-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075772-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075772-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075772-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075772-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075772-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075772-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075772-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075772-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075772-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075772-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075772-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075772-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075772-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075772-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075772-002	AP	1	`bb7c543d1eb4…`

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	Hikma Pharmaceuticals USA Inc.	0c2c75c9-ed7b-46a8-9543-429bf2d8f090	2024-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075772 application number: ANDA075772 ndc (product): 0641-6041 ndc (product): 0641-6043 ndc (product): 0641-6042

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0641-6041	Ketorolac Tromethamine	Ketorolac Tromethamine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6041	Ketorolac Tromethamine	Ketorolac Tromethamine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6041	Ketorolac Tromethamine	Ketorolac Tromethamine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6041	Ketorolac Tromethamine	Ketorolac Tromethamine	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6042	Ketorolac Tromethamine	Ketorolac Tromethamine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6042	Ketorolac Tromethamine	Ketorolac Tromethamine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6042	Ketorolac Tromethamine	Ketorolac Tromethamine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6042	Ketorolac Tromethamine	Ketorolac Tromethamine	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6043	Ketorolac Tromethamine	Ketorolac Tromethamine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6043	Ketorolac Tromethamine	Ketorolac Tromethamine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6043	Ketorolac Tromethamine	Ketorolac Tromethamine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6043	Ketorolac Tromethamine	Ketorolac Tromethamine	West-Ward Pharmaceuticals Corp.	ANDA	Current
50090-4583	Ketorolac Tromethamine	Ketorolac Tromethamine	A-S Medication Solutions	ANDA	Current
50090-4583	Ketorolac Tromethamine	Ketorolac Tromethamine	A-S Medication Solutions	ANDA	Current
52584-084	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	General Injectables and Vaccines, Inc.	ANDA	Current
70518-1239	Ketorolac Tromethamine	Ketorolac Tromethamine	REMEDYREPACK INC.	ANDA	Current
70518-1239	Ketorolac Tromethamine	Ketorolac Tromethamine	REMEDYREPACK INC.	ANDA	Current