Application 074376

Type: ANDA
Sponsor: CASI PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	TABLET, DELAYED RELEASE;ORAL	25MG	No	No
002	DICLOFENAC SODIUM	DICLOFENAC SODIUM	TABLET, DELAYED RELEASE;ORAL	50MG	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
A074376-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28
A074376-002	DICLOFENAC SODIUM	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28

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 · 86 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	A074376-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074376-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074376-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074376-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074376-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074376-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074376-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074376-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074376-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074376-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074376-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074376-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074376-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074376-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074376-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074376-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074376-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074376-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074376-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074376-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074376-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074376-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074376-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074376-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074376-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074376-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074376-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074376-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074376-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074376-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074376-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074376-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074376-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074376-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074376-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074376-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074376-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074376-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074376-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	1995-09-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074376-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	1995-09-28	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A074376-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074376-002	AB	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A074376-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074376-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074376-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074376-002	AB	1	`ea99ee380514…`

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 15 of 16 · 312 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac sodium	DICLOFENAC SODIUM	Costco Wholesale	141b6693-6d6c-45c6-9b82-ee1afcfca12a	2023-01-27	Warnings	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	Proficient Rx LP	b4694451-a13d-484e-92c4-c03a6fcbb511	2023-01-01	Warnings	Name fallback brand name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Proficient Rx LP	b98d921a-2ee7-4770-ac21-d845b2dcc11c	2023-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
Arthritis Pain Reliever	DICLOFENAC SODIUM	P & L Development, LLC	2596645a-b736-4d3c-82a0-00713f1b6fbd	2022-12-15	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac	DICLOFENAC SODIUM	Altaire Pharmaceuticals Inc.	5372866a-dab3-45c8-8c2a-755ca36c1791	2022-10-28	Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC	Asclemed USA, Inc.	9df599de-6412-a94e-e053-2995a90a1741	2022-10-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium
Diclofenac sodium	DICLOFENAC SODIUM	Asclemed USA, Inc.	d4b81a74-6926-4715-bf90-aec026cff2b4	2022-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Asclemed USA, Inc.	b162d65d-b105-4a68-90bb-316b9686267b	2022-08-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Rite Aid Corporation	1c9ea3b2-8f45-420b-87d3-dc7de0be2d5f	2022-08-23	Warnings	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
diclofenac sodium	DICLOFENAC SODIUM	Proficient Rx LP	67e384c6-8476-4aad-b967-241335538d56	2022-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: diclofenac sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Proficient Rx LP	afce2de2-0c59-4191-bf79-782ca31e427d	2022-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	3a520306-fe3e-4830-963f-04b080db3abc	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
good sense arthritis pain	DICLOFENAC SODIUM	Proficient Rx LP	67eacd91-8378-47e7-9bad-1e7b685aa9d4	2022-06-01	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	9eeb2aef-3eb1-4583-8180-d480deb3651c	2022-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	1c1ee94c-60d6-4cfc-bb66-1d4f6e630512	2022-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Proficient Rx LP	947c0c1f-3573-4f69-ab82-8b50c43e5586	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Arthritis Pain Reliever	DICLOFENAC SODIUM	CVS PHARMACY, INC	047985ea-f768-4f9a-bfe3-0acf40a4781d	2022-02-15	Warnings	Name fallback generic name: DICLOFENAC SODIUM
basic care arthritis pain	DICLOFENAC SODIUM	Amazon.com Services LLC	a8aa9016-bf2d-4727-9184-512b2570000b	2022-01-06	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Sandoz Inc	52d22a6b-3acd-4694-9df5-8cfa9cc2bb2b	2021-09-29	Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Actavis Pharma, Inc.	a57b897e-0cbe-4ac3-969f-b00357a0cfa8	2021-08-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-1785	Diclofenac Sodium	Diclofenac Sodium	Sandoz Inc	ANDA	Current
0781-1787	Diclofenac Sodium	Diclofenac Sodium	Sandoz Inc	ANDA	Current
55289-166	Diclofenac Sodium	Diclofenac Sodium	PD-Rx Pharmaceuticals, In	ANDA	Current
68001-201	Diclofenac Sodium	Diclofenac Sodium	BluePoint Laboratories	ANDA	Current
68001-202	Diclofenac Sodium	Diclofenac Sodium	BluePoint Laboratories	ANDA	Current
68151-2481	Diclofenac Sodium	Diclofenac Sodium	Carilion Materials Management	ANDA	Current