Application 075229

Type: ANDA
Sponsor: CASI PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	TABLET;ORAL	50MG	No	No
002	DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	TABLET;ORAL	25MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075229-001	DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1998-11-20
A075229-002	DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075229-001	AB
A075229-002	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.

Product history page 1 of 2 · 78 observed 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
2026-09-14 22:38:34	2026-08	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1998-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1998-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1998-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1998-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1998-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A075229-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075229-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075229-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075229-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075229-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075229-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075229-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075229-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075229-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075229-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075229-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075229-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075229-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A075229-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075229-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A075229-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075229-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075229-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075229-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075229-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075229-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075229-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075229-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075229-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075229-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A075229-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075229-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A075229-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075229-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075229-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075229-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A075229-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075229-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A075229-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075229-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075229-002	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075229-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075229-002	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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Potassium	DICLOFENAC POTASSIUM	NuCare Pharmaceuticals,Inc.	d61cbb27-737d-948c-e053-2a95a90adaca	2026-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075229 application number: ANDA075229 ndc (product): 68071-2625
Diclofenac Potassium	DICLOFENAC POTASSIUM	Bryant Ranch Prepack	86461915-9bc1-43d4-8d92-6eef3e56bd90	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075229 application number: ANDA075229 ndc (product): 71335-2052
Diclofenac Potassium	DICLOFENAC POTASSIUM	Northwind Health Company, LLC	f2b6a4dd-e4e2-4acc-e053-2995a90aebf2	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075229 application number: ANDA075229
Diclofenac Potassium	DICLOFENAC POTASSIUM	Trifluent Pharma LLC	8fdb1036-c0d8-4288-ac37-6512b05672ef	2025-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075229 application number: ANDA075229
Diclofenac Potassium	DICLOFENAC POTASSIUM	INA Pharmaceutics Inc	5ecd99fe-cb74-4a65-9636-2aefd2416ece	2025-10-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075229 application number: ANDA075229 ndc (product): 74157-007
Diclofenac Potassium	DICLOFENAC POTASSIUM	Coupler LLC	2eead069-f954-abb2-e063-6394a90a14ff	2025-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075229 application number: ANDA075229
Diclofenac Potassium	DICLOFENAC POTASSIUM	A-S Medication Solutions	112e7c94-23c8-451e-ae71-eb89a6eb2cb2	2023-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075229 application number: ANDA075229 ndc (product): 50090-5893
Diclofenac Potassium	DICLOFENAC POTASSIUM	Proficient Rx LP	94586867-c75b-4d60-be1d-03a9e4b7cd10	2023-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075229 application number: ANDA075229

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-5017	Diclofenac Potassium	Diclofenac Potassium	Sandoz Inc	ANDA	Current
12634-827	DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	APOTHECA, INC	ANDA	Current
50090-0647	Diclofenac Potassium	Diclofenac Potassium	A-S Medication Solutions	ANDA	Current
50090-5893	Diclofenac Potassium	diclofenac potassium	A-S Medication Solutions	ANDA	Current
55289-781	Diclofenac Potassium	Diclofenac Potassium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-781	Diclofenac Potassium	Diclofenac Potassium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55700-989	Diclofenac Potassium	diclofenac potassium	Quality Care Products, LLC	ANDA	Current
68071-2625	Diclofenac Potassium	diclofenac potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2625	Diclofenac Potassium	diclofenac potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
71335-2052	Diclofenac Potassium	diclofenac potassium	Bryant Ranch Prepack	ANDA	Current
71335-2052	Diclofenac Potassium	diclofenac potassium	Bryant Ranch Prepack	ANDA	Current
72888-073	Diclofenac Potassium	diclofenac potassium	Advagen Pharma Ltd	ANDA	Current
72888-073	Diclofenac Potassium	diclofenac potassium	Advagen Pharma Ltd	ANDA	Current
72888-073	Diclofenac Potassium	diclofenac potassium	Advagen Pharma Ltd	ANDA	Current
72888-073	Diclofenac Potassium	diclofenac potassium	Advagen Pharma Ltd	ANDA	Current
72888-073	Diclofenac Potassium	diclofenac potassium	Advagen Pharma Ltd	ANDA	Current
72888-086	Diclofenac Potassium	diclofenac potassium	Advagen Pharma Ltd	ANDA	Current
74157-007	Diclofenac Potassium	diclofenac potassium	INA Pharmaceutics Inc	ANDA	Current
74157-007	Diclofenac Potassium	diclofenac potassium	INA Pharmaceutics Inc	ANDA	Current
74157-007	Diclofenac Potassium	diclofenac potassium	INA Pharmaceutics Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8571	ORIG	1998-11-20