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 5 of 16 · 312 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DICLOFENAC SODIUM TOPICAL	DICLOFENAC SODIUM	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	181e32ab-5ec0-4be4-bad0-b6bbafc08f85	2026-01-15	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Sportpharm LLC	929f71ab-f0c8-4331-800d-ed4a172e647e	2026-01-14	Warnings	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Sportpharm LLC	ac631742-119f-408a-8b36-b041bab743e2	2026-01-14	Warnings	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	AvKARE	19b4ff5c-adb7-a0d0-7ef2-4ae05047fd94	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	AvKARE	0416ce03-c345-9d9e-e063-6294a90ad940	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM 1%	Asclemed USA, Inc.	6952a221-17fd-4592-8edc-ff3699743533	2026-01-13	Warnings	Name fallback brand name: Diclofenac Sodium
Aspercreme Arthritis	DICLOFENAC SODIUM	Chattem, Inc.	81f78685-c416-48b5-8840-eef03a66bc28	2026-01-12	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	14c1b1a1-bc06-4722-9612-e88ae52272bc	2026-01-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	1e669fc2-69bf-4439-a336-a103e5b9cafe	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	8825dc2c-3497-455f-b5e1-2aa667291957	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	PHOENIX RX LLC	47ce6fab-be1d-0076-e063-6294a90add63	2026-01-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Arthritis Pain Reliever	DICLOFENAC SODIUM	QUALITY CHOICE (Chain Drug Marketing Association)	98f94aa2-6bc2-4c07-81c8-63b2c262cf39	2026-01-06	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Northwind Health Company, LLC	c16e7e43-3869-9fef-e053-2995a90a1fdb	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Northwind Health Company, LLC	f2b7ea75-738b-54a8-e053-2995a90a00d5	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	47a7a294-55bb-8d19-e063-6394a90a5440	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	40388047-7fbe-49bf-bed8-e5087bed4e03	2025-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	4a88f136-f7c7-47d7-b85d-8a2f9f118f09	2025-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Safeway, Inc.	196d8af7-739f-4d2c-8c4e-9d33e6d722ab	2025-12-23	Warnings	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Redpharm Drug	325213a3-241c-18d2-e063-6394a90a40f7	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	58063c26-86fe-4f03-97ef-51706e5f4054	2025-12-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM

Reported adverse events (FAERS/openFDA)#

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