Application 074754

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	TABLET;ORAL	10MG	No	Yes

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
A074754-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074754-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A074754-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	REMEDYREPACK INC.	f47d4365-40a8-445b-99cd-49edad6a8ffc	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754 ndc (product): 70518-0048
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Sportpharm LLC	0749f61d-12e6-4280-8f41-bd4df81e7ae6	2026-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Northwind Health Company, LLC	d17ed469-677b-4a2e-96a9-5cfd0f50ecd9	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754 ndc (product): 51655-170
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	American Health Packaging	48244614-53ec-47e6-ad48-50814bdcceb7	2025-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754 ndc (product): 60687-104
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	PD-Rx Pharmaceuticals, Inc.	add10ccd-c205-4512-9619-253290fa1152	2025-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754 ndc (product): 43063-904
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	9fdba2e6-969f-4624-b08b-a42f99e4eff9	2025-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754 ndc (product): 50090-0601
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Advanced Rx Pharmacy of Tennessee, LLC	c1717245-cef3-b3d7-e053-2a95a90a1ac5	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Teva Pharmaceuticals USA, Inc.	688f5dec-a6db-43c6-a1f8-5df99d08d395	2024-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754 ndc (product): 0093-0314
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	NuCare Pharmaceuticals, Inc.	415a5393-296f-30e3-e054-00144ff8d46c	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754 ndc (product): 66267-418
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	NuCare Pharmaceuticals, Inc.	46dc8f62-e754-50e3-e054-00144ff8d46c	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754 ndc (product): 66267-832
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Bryant Ranch Prepack	f713500a-20b8-8e20-c4cc-956805170335	2023-11-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754 ndc (product): 63629-2974
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Asclemed USA, Inc.	94c7c57a-fd1e-41ab-bc39-9a538f6011d1	2023-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Proficient Rx LP	f5170993-81a9-4eb7-95ac-60697a5ee1d7	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754 ndc (product): 63187-128

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 86 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-0314	Ketorolac Tromethamine	Ketorolac Tromethamine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0314	Ketorolac Tromethamine	Ketorolac Tromethamine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0314	Ketorolac Tromethamine	Ketorolac Tromethamine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0314	Ketorolac Tromethamine	Ketorolac Tromethamine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0314	Ketorolac Tromethamine	Ketorolac Tromethamine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0314	Ketorolac Tromethamine	Ketorolac Tromethamine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0314	Ketorolac Tromethamine	Ketorolac Tromethamine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
10544-222	Ketorolac Tromethamine	Ketorolac Tromethamine	Blenheim Pharmacal, Inc.	ANDA	Current
12634-809	Ketorolac Tromethamine	Ketorolac Tromethamine	Apotheca, Inc	ANDA	Current
21695-432	Ketorolac Tromethamine	Ketorolac Tromethamine	Rebel Distributors Corp	ANDA	Current
33261-065	Ketorolac Tromethamine	Ketorolac Tromethamine	Aidarex Pharmaceuticals LLC	ANDA	Current
35356-696	Ketorolac Tromethamine	Ketorolac Tromethamine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-696	Ketorolac Tromethamine	Ketorolac Tromethamine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-696	Ketorolac Tromethamine	Ketorolac Tromethamine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-696	Ketorolac Tromethamine	Ketorolac Tromethamine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-696	Ketorolac Tromethamine	Ketorolac Tromethamine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-696	Ketorolac Tromethamine	Ketorolac Tromethamine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-696	Ketorolac Tromethamine	Ketorolac Tromethamine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
42291-358	Ketorolac Tromethamine	Ketorolac Tromethamine	AvKARE, Inc.	ANDA	Current
42291-358	Ketorolac Tromethamine	Ketorolac Tromethamine	AvKARE, Inc.	ANDA	Current
42291-358	Ketorolac Tromethamine	Ketorolac Tromethamine	AvKARE	ANDA	Current
43063-904	Ketorolac Tromethamine	Ketorolac Tromethamine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-904	Ketorolac Tromethamine	Ketorolac Tromethamine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-904	Ketorolac Tromethamine	Ketorolac Tromethamine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-904	Ketorolac Tromethamine	Ketorolac Tromethamine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-904	Ketorolac Tromethamine	Ketorolac Tromethamine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-904	Ketorolac Tromethamine	Ketorolac Tromethamine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
45865-657	Ketorolac Tromethamine	Ketorolac Tromethamine	Medsource Pharmaceuticals	ANDA	Current
50090-0601	Ketorolac Tromethamine	Ketorolac Tromethamine	A-S Medication Solutions	ANDA	Current
50090-0601	Ketorolac Tromethamine	Ketorolac Tromethamine	A-S Medication Solutions	ANDA	Current
50436-7382	Ketorolac Tromethamine	Ketorolac Tromethamine	Unit Dose Services	ANDA	Current
51655-170	Ketorolac Tromethamine	Ketorolac Tromethamine	Northwind Pharmaceuticals, LLC	ANDA	Current
51655-170	Ketorolac Tromethamine	Ketorolac Tromethamine	Northwind Pharmaceuticals	ANDA	Current
52959-512	Ketorolac Tromethamine	Ketorolac Tromethamine	H.J. Harkins Company, Inc.	ANDA	Current
53002-6990	Ketorolac Tromethamine	Ketorolac Tromethamine	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-6990	Ketorolac Tromethamine	Ketorolac Tromethamine	RPK Pharmaceuticals, Inc.	ANDA	Current
60687-104	Ketorolac Tromethamine	Ketorolac Tromethamine	American Health Packaging	ANDA	Current
60687-104	Ketorolac Tromethamine	Ketorolac Tromethamine	American Health Packaging	ANDA	Current
60760-314	Ketorolac Tromethamine	Ketorolac Tromethamine	St. Mary	ANDA	Current
61919-138	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	DIRECT RX	ANDA	Current
61919-138	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	DIRECT RX	ANDA	Current
61919-138	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	DIRECT RX	ANDA	Current
63187-128	Ketorolac Tromethamine	Ketorolac Tromethamine	Proficient Rx LP	ANDA	Current
63187-128	Ketorolac Tromethamine	Ketorolac Tromethamine	Proficient Rx LP	ANDA	Current
63187-128	Ketorolac Tromethamine	Ketorolac Tromethamine	Proficient Rx LP	ANDA	Current
63187-128	Ketorolac Tromethamine	Ketorolac Tromethamine	Proficient Rx LP	ANDA	Current
63187-128	Ketorolac Tromethamine	Ketorolac Tromethamine	Proficient Rx LP	ANDA	Current
63187-128	Ketorolac Tromethamine	Ketorolac Tromethamine	Proficient Rx LP	ANDA	Current
63629-2974	Ketorolac Tromethamine	Ketorolac Tromethamine	Bryant Ranch Prepack	ANDA	Current
63629-2974	Ketorolac Tromethamine	Ketorolac Tromethamine	Bryant Ranch Prepack	ANDA	Current
63629-2974	Ketorolac Tromethamine	Ketorolac Tromethamine	Bryant Ranch Prepack	ANDA	Current
66267-418	Ketorolac Tromethamine	Ketorolac Tromethamine	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-418	Ketorolac Tromethamine	Ketorolac Tromethamine	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-418	Ketorolac Tromethamine	Ketorolac Tromethamine	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-418	Ketorolac Tromethamine	Ketorolac Tromethamine	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-418	Ketorolac Tromethamine	Ketorolac Tromethamine	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-418	Ketorolac Tromethamine	Ketorolac Tromethamine	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-418	Ketorolac Tromethamine	Ketorolac Tromethamine	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-418	Ketorolac Tromethamine	Ketorolac Tromethamine	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-832	Ketorolac Tromethamine	Ketorolac Tromethamine	NuCare Pharmaceuticals, I	ANDA	Current
66267-832	Ketorolac Tromethamine	Ketorolac Tromethamine	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-832	Ketorolac Tromethamine	Ketorolac Tromethamine	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-832	Ketorolac Tromethamine	Ketorolac Tromethamine	NuCare Pharmaceuticals, Inc.	ANDA	Current
67296-0511	Ketorolac Tromethamine	Ketorolac Tromethamine	RedPharm Drug, Inc.	ANDA	Current
68071-2737	Ketorolac Tromethamine	Ketorolac Tromethamine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68151-0098	Ketorolac Tromethamine	Ketorolac Tromethamine	Carilion Materials Management	ANDA	Current
68387-440	Ketorolac Tromethamine	Ketorolac Tromethamine	Keltman Pharmaceuticals Inc.	ANDA	Current
68788-8149	Ketorolac Tromethamine	Ketorolac Tromethamine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9205	Ketorolac Tromethamine	Ketorolac Tromethamine	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0048	Ketorolac Tromethamine	Ketorolac Tromethamine	REMEDYREPACK INC.	ANDA	Current
70518-0048	Ketorolac Tromethamine	Ketorolac Tromethamine	REMEDYREPACK INC.	ANDA	Current
70518-0048	Ketorolac Tromethamine	Ketorolac Tromethamine	REMEDYREPACK INC.	ANDA	Current
70518-0048	Ketorolac Tromethamine	Ketorolac Tromethamine	REMEDYREPACK INC.	ANDA	Current
70518-0048	Ketorolac Tromethamine	Ketorolac Tromethamine	REMEDYREPACK INC.	ANDA	Current
70518-0048	Ketorolac Tromethamine	Ketorolac Tromethamine	REMEDYREPACK INC.	ANDA	Current
70518-0048	Ketorolac Tromethamine	Ketorolac Tromethamine	REMEDYREPACK INC.	ANDA	Current
70518-0048	Ketorolac Tromethamine	Ketorolac Tromethamine	REMEDYREPACK INC.	ANDA	Current
70934-029	Ketorolac Tromethamine	Ketorolac Tromethamine	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-029	Ketorolac Tromethamine	Ketorolac Tromethamine	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-029	Ketorolac Tromethamine	Ketorolac Tromethamine	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42876	ORIG	1997-05-16