Application 217038

Type: ANDA
Sponsor: ZYDUS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	TABLET;ORAL	10MG	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
A217038-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		2022-10-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217038-001	AB

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.

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	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`3a93d1ddd44b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217038-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217038-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217038-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217038-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217038-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217038-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217038-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217038-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217038-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217038-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217038-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217038-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217038-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217038-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217038-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217038-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217038-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217038-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217038-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217038-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A217038-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A217038-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A217038-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A217038-001	AB	1	`3a93d1ddd44b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217038-001	AB	1	`a50c72e98297…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ketorolac tromethamine	KETOROLAC TROMETHAMINE	REMEDYREPACK INC.	b0aa1137-d0c3-4e4e-b1ec-5fe4b24e570a	2026-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217038 application number: ANDA217038
ketorolac tromethamine	KETOROLAC TROMETHAMINE	Preferred Pharmaceuticals Inc.	1e7ae5af-76b9-49a9-ba14-52b566929c22	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217038 application number: ANDA217038
ketorolac tromethamine	KETOROLAC TROMETHAMINE	Redpharm Drug	51d443f8-716d-af3a-e063-6394a90a56a3	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217038 application number: ANDA217038
ketorolac tromethamine	KETOROLAC TROMETHAMINE	Bryant Ranch Prepack	23e7b5f7-ea0d-468d-9d13-a95f9bf605c6	2026-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217038 application number: ANDA217038
ketorolac tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	d8e928ac-c1e7-4b7a-87cd-9d11e36d53c0	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217038 application number: ANDA217038
ketorolac tromethamine	KETOROLAC TROMETHAMINE	NuCare Pharmaceuticals,Inc.	fe7eb195-48be-753b-e053-6294a90a8500	2025-04-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217038 application number: ANDA217038
ketorolac tromethamine	KETOROLAC TROMETHAMINE	Zydus Lifesciences Limited	5a4192e8-d9e5-4f09-99f6-da5a648b1aac	2024-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217038 application number: ANDA217038 ndc (product): 70771-1747
ketorolac tromethamine	KETOROLAC TROMETHAMINE	Zydus Pharmaceuticals (USA) Inc.	ffd84ef3-26ed-4810-952b-4f0e913c5e32	2024-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217038 application number: ANDA217038 ndc (product): 70710-1710
ketorolac tromethamine	KETOROLAC TROMETHAMINE	NuCare Pharmaceuticals,Inc.	155c9171-d394-9c28-e063-6394a90a8209	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217038 application number: ANDA217038

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70710-1710	ketorolac tromethamine	ketorolac tromethamine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1747	ketorolac tromethamine	ketorolac tromethamine	Zydus Lifesciences Limited	ANDA	Current