Application 209900

Type: ANDA
Sponsor: BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	INJECTABLE;INJECTION	30MG/ML	No	No
002	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	INJECTABLE;INJECTION	15MG/ML	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
A209900-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP		2017-09-15
A209900-002	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP		2018-07-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209900-001	AP
A209900-002	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	A209900-001	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2017-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209900-002	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2018-07-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209900-001	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209900-002	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2018-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209900-001	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2017-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209900-002	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2018-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209900-001	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2017-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209900-002	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2018-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209900-001	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2017-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209900-002	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2018-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209900-001	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2017-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209900-002	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2018-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209900-001	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2017-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209900-002	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2018-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209900-001	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2017-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209900-002	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2018-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209900-001	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2017-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209900-002	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2018-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209900-001	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2017-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209900-002	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2018-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209900-001	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2017-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209900-002	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2018-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209900-001	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2017-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209900-002	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2018-07-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209900-001	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2017-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209900-002	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2018-07-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209900-001	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2017-09-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209900-002	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2018-07-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209900-001	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2017-09-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209900-002	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2018-07-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209900-001	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2017-09-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209900-002	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2018-07-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209900-001	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2017-09-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209900-002	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2018-07-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209900-001	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2017-09-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209900-002	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2018-07-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209900-001	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2017-09-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209900-002	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2018-07-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209900-001	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2017-09-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209900-002	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2018-07-25	`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	A209900-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209900-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209900-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209900-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209900-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209900-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209900-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209900-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209900-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209900-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209900-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209900-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209900-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209900-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209900-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209900-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209900-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209900-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209900-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209900-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209900-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209900-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209900-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209900-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209900-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209900-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209900-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209900-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209900-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209900-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209900-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209900-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209900-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209900-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209900-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209900-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209900-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209900-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209900-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209900-002	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Civica, Inc.	1e8ddf13-c513-4e16-a91a-9d55726d9071	2024-11-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209900 application number: ANDA209900
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	Baxter Healthcare Corporation	4b58836d-9d58-4539-9691-9e11c505ef2a	2024-09-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209900 application number: ANDA209900 ndc (product): 0338-0069 ndc (product): 0338-0076 ndc (product): 0338-0072

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0069	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Baxter Healthcare Corporation	ANDA	Current
0338-0069	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Baxter Healthcare Corporation	ANDA	Current
0338-0069	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Baxter Healthcare Corporation	ANDA	Current
0338-0069	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Baxter Healthcare Corporation	ANDA	Current
0338-0069	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Baxter Healthcare Corporation	ANDA	Current
0338-0069	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Baxter Healthcare Corporation	ANDA	Current
0338-0069	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Baxter Healthcare Corporation	ANDA	Current
0338-0072	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Baxter Healthcare Corporation	ANDA	Current
0338-0072	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Baxter Healthcare Corporation	ANDA	Current
0338-0072	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Baxter Healthcare Corporation	ANDA	Current
0338-0072	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Baxter Healthcare Corporation	ANDA	Current
0338-0072	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Baxter Healthcare Corporation	ANDA	Current
0338-0072	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Baxter Healthcare Corporation	ANDA	Current
0338-0072	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Baxter Healthcare Corporation	ANDA	Current
0338-0076	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Baxter Healthcare Corporation	ANDA	Current
0338-0076	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Baxter Healthcare Corporation	ANDA	Current
0338-0076	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Baxter Healthcare Corporation	ANDA	Current
0338-0076	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Baxter Healthcare Corporation	ANDA	Current
0338-0076	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Baxter Healthcare Corporation	ANDA	Current
0338-0076	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Baxter Healthcare Corporation	ANDA	Current
0338-0076	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Baxter Healthcare Corporation	ANDA	Current
69543-386	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-386	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-405	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-405	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-407	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-407	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Virtus Pharmaceuticals, LLC	ANDA	Current
70518-1165	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	REMEDYREPACK INC.	ANDA	Current
70518-2187	KETOROLAC TROMETHAMINE	ketorolac tromethamine	REMEDYREPACK INC.	ANDA	Current
71872-7118	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7118	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Medical Purchasing Solutions, LLC	ANDA	Current