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 1.

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 · 82 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
2026-02-19 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…`
2022-03-09 01:35 UTC	2022-03	A074376-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074376-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074376-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074376-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL			1995-09-28	`782e0a99824c…`

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 1 of 16 · 313 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC SODIUM	PD-Rx Pharmaceuticals, Inc.	681b6b25-4a28-44f2-8042-d5e01a502116	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals, Inc.	57c83158-f072-6fa2-e063-6394a90aee2c	2026-07-29	Warnings	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	ddd2278b-70be-41ca-8a84-e3fe0f1a1561	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	CVS Pharmacy	591cc2ed-e667-4779-a426-8a2e6f873573	2026-07-22	Warnings	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Aurobindo Pharma Limited	d9b6f1d0-1710-46fb-8ea4-80b3ca60a575	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC SODIUM generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	HAWAII REPACK, INC	ea113a58-c7ed-4768-9777-93d9b166dfbe	2026-07-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC SODIUM generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM 1%	Sportpharm LLC	391d9d0b-74b7-4359-aea0-d3bb8c8d3cd1	2026-07-10	Warnings	Name fallback brand name: Diclofenac Sodium
Diclofenac Sodium	DICLOFENAC SODIUM	American Health Packaging	63c00b50-06d3-4659-81cf-be4516429e81	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	REMEDYREPACK INC.	6e6a6f98-5517-4f67-9a6a-71019ba2d773	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC SODIUM generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	71a823c4-9c88-474d-b525-276f9e7808aa	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	09643e65-f301-4891-96f4-d78bf3621e23	2026-07-02	Warnings	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	30c7e4fd-30af-4d28-a6ef-7386ff83cfb8	2026-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	American Health Packaging	dbb1489d-b690-4e53-905d-7fb07ad263b3	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
ARTHRITIS PAIN RELIEF	DICLOFENAC SODIUM	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	84978746-4ab5-456d-af63-5c86ab0a05f5	2026-06-29	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	10991fe6-fafd-49af-9684-83b447c19c67	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	REMEDYREPACK INC.	6980431d-4a2b-41e9-ae86-d46b4513f04b	2026-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	ASCLEMED USA INC.	53e8ad44-ff67-d3bb-e063-6394a90a524d	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL	REMEDYREPACK INC.	cc8c3125-ee43-40bb-8500-339efa901b8c	2026-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium
Diclofenac Sodium	DICLOFENAC SODIUM	St. Mary's Medical Park Pharmacy	5f4b69de-8ddd-26c5-e053-2a91aa0ab326	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Golden State Medical Supply, Inc.	c1d87003-f54b-4381-9e11-1c39ea2d9eb3	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM

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