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 4 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	NuCare Pharmaceuticals,Inc.	06862cf2-9537-6661-e063-6294a90a2084	2026-02-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC SODIUM generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Bryant Ranch Prepack	03c4f06f-6a49-4404-bf3b-0aafa33c81ef	2026-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Rugby Laboratories	95f3c70c-eded-4d24-b9b0-cfa0b7902d6e	2026-02-10	Warnings	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	Sportpharm LLC	a133d18e-981d-43b7-bef1-7869f7c7d9a7	2026-02-09	Warnings	Name fallback brand name: DICLOFENAC SODIUM
diclofenac sodium	DICLOFENAC SODIUM	REMEDYREPACK INC.	6aab6c1f-9b02-4101-b7c8-ab7a55704320	2026-02-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: diclofenac sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	SOLA Pharmaceuticals, LLC	11e88ced-cdcf-4101-9297-c4c3dde9d089	2026-02-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Sportpharm LLC	99f1e69e-02cf-49c2-83af-3cccbbea4215	2026-02-06	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	0cefb675-c54e-44eb-b35c-38354b77eddd	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	74011b00-7e2e-40a7-ab30-c05a20559814	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Umedica Laboratories USA Inc.	0e5c6669-390f-4c32-b9b8-13ed3c517462	2026-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Arthritis Pain Reliever	DICLOFENAC SODIUM	Family Dollar (FAMILY WELLNESS)	03ddf347-a3a3-4313-87d1-a246c1d4e0b4	2026-01-29	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Golden State Medical Supply, Inc.	468fab22-2b69-4a2c-e063-6294a90aab9a	2026-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Bausch & Lomb Incorporated	39dfffb0-612a-48f3-8db5-1a59899b91e9	2026-01-27	Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Ingenus Pharmaceuticals, LLC	1a237198-ca24-4159-b570-b5a23c8e91b0	2026-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	4ee64a93-9965-47c8-be2c-14232df44b2b	2026-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	A-S Medication Solutions	f92576d7-3ad9-43a3-8b10-3a29fbf712a4	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC SODIUM generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	A-S Medication Solutions	6c57e330-ebbe-4165-84a8-4844b2f0097e	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC SODIUM generic name: DICLOFENAC SODIUM
ARTHRITIS PAIN RELIEVER	DICLOFENAC SODIUM	Publix Super Markets Inc	bae07276-c800-468e-a201-e6268846fff3	2026-01-15	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	47793dca-5e9e-44ee-8e66-5e42e1831b1e	2026-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	b74be49d-74ff-491b-962b-0edd3a57cbc9	2026-01-15	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.