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 16 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 TOPICAL GEL, 1%,	Proficient Rx LP	7e98952e-9b95-4296-9c23-c0ff4b82b2b7	2021-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium
Diclofenac Sodium	DICLOFENAC SODIUM	Asclemed USA, Inc.	f3f60cd3-8f1f-4ca4-9621-805b4a6c35a8	2021-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Asclemed USA, Inc.	57d8513a-820a-46c5-b0c8-5aa1811b0e88	2020-10-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC SODIUM generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL GEL, 1%,	Asclemed USA, Inc.	988abe66-0b3b-4c13-87b4-adc913227fc5	2020-10-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	20107264-e533-4de9-9a37-59fde7981c92	2020-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Asclemed USA, Inc.	1e39f8d4-56a2-4d29-a971-495574e8d4a7	2020-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	7bc185e2-e749-4a24-8550-c2f6d39222d2	2020-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Proficient Rx LP	b0f9e649-6651-406f-a9fe-157fe04d9d27	2020-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	a7447467-79e0-436e-a273-d1ddd06169cf	2019-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	77c3cb56-c071-4d92-a0d6-022417a27de4	2019-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Aphena Pharma Solutions - Tennessee, LLC	e4af374a-1281-46af-a0a9-48820db6c947	2018-05-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Novel Laboratories, Inc.	c99f5ef6-c777-4896-a5e7-7335257439b2	2016-06-16	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