Application 074391

Type: ANDA
Sponsor: ROXANE

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
003	DICLOFENAC SODIUM	DICLOFENAC SODIUM	TABLET, DELAYED RELEASE;ORAL	75MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A074391-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29
A074391-002	DICLOFENAC SODIUM	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29
A074391-003	DICLOFENAC SODIUM	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074391-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074391-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074391-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074391-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074391-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074391-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074391-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074391-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074391-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074391-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074391-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074391-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074391-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074391-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074391-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074391-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074391-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074391-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074391-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074391-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074391-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074391-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074391-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074391-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074391-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074391-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074391-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074391-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074391-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074391-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074391-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074391-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074391-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074391-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074391-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074391-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074391-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074391-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074391-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074391-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	1995-06-29	`301d65b070ca…`

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 8 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	Sun Pharmaceutical Industries, Inc.	f9a0c654-5f77-430f-b921-295eb776cbcd	2025-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Advagen Pharma Ltd	ac2b4060-a5da-4ddf-a734-2ff58a1f98c9	2025-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Sun Pharmaceutical Industries, Inc.	aa1e1ed3-0444-4bf5-a0ee-5d21a7fca391	2025-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
Arthritis Pain Reliever	DICLOFENAC SODIUM	Chain Drug Consortium, LLC	8879a2ed-6c66-4489-8adc-9f160241cc7d	2025-06-25	Warnings	Name fallback generic name: DICLOFENAC SODIUM
kirkland signature arthritis pain relief	DICLOFENAC SODIUM	Costco Wholesale Company	c30353da-acd6-474f-8a64-abd078bf4f85	2025-06-11	Warnings	Name fallback generic name: DICLOFENAC SODIUM
members mark arthritis pain reliever	DICLOFENAC SODIUM	Sam's West Inc	44533b5b-73ce-4853-9eda-506426cb9b82	2025-06-09	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Carlsbad Technology, Inc.	363764a0-e0a8-3e3f-e063-6294a90ad672	2025-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC	Amneal Pharmaceuticals LLC	45321aec-368d-4ca4-a0c5-2ce56fae74b2	2025-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Carlsbad Technology, Inc.	40879600-ba6c-43a8-aa5d-d0d41503d593	2025-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Aurobindo Pharma Limited	3487033c-7c62-4034-8718-73a7c49b26a0	2025-05-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC SODIUM generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	PD-Rx Pharmaceuticals, Inc.	87d5a720-f154-4c4b-b2d4-0ae58455dda0	2025-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	Dr. Reddy's Laboratories Inc.	03abebd6-426a-9d05-3dff-196477389430	2025-05-05	Warnings	Name fallback brand name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	BluePoint Laboratories	896e3f7d-88e6-4563-b879-a2757d19fd62	2025-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Advagen Pharma Ltd	72419a68-4c9d-44e0-9b43-922440e2c8d7	2025-04-30	Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC SODIUM generic name: DICLOFENAC SODIUM
up and up arthritis pain reliever	DICLOFENAC SODIUM	Target Corporation	0b7ae58c-cdaf-4343-a199-7a90bf901eb5	2025-04-27	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	NorthStar Rx LLC	c7431496-c0ef-403a-9716-92d942709b3d	2025-04-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	GERI-CARE PHARMACEUTICAL CORP	fc08e58c-6323-e667-e053-6394a90ab754	2025-04-21	Warnings	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	RedPharm Drug, Inc.	4ecb7bdc-4a5e-7444-e054-00144ff88e88	2025-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Bryant Ranch Prepack	487fa223-f4d9-4ab1-a5af-fb0d93f2bd0e	2025-03-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	INNOVUS PHARMACEUTICALS, INC.	ad9d2c28-21bc-4f81-9c90-cce6a96d976a	2025-03-25	Warnings	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.