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 11 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	Quality Care Products, LLC	12e1f808-9f24-4f6d-b5bc-12ce0059ab7a	2024-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	f18a4691-93a1-01e6-e053-2995a90a0069	2024-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals, LLC.	26e44aa5-cfcd-f10b-e063-6394a90a4dcf	2024-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC	Scholl's Wellness Company	8dcbce69-945b-4913-a279-ee10871f6580	2024-11-14	Warnings	Name fallback brand name: Diclofenac sodium
Salonpas	DICLOFENAC SODIUM	Hisamitsu America, Inc.	f439445d-046e-4220-a4a7-13d750ee0949	2024-11-14	Warnings	Name fallback generic name: DICLOFENAC SODIUM
MOTRIN ARTHRITIS PAIN	DICLOFENAC SODIUM	Kenvue Brands LLC	db5b4288-13ec-826b-e053-2995a90a275e	2024-11-08	Warnings	Name fallback generic name: DICLOFENAC SODIUM
diclofenac sodium	DICLOFENAC SODIUM	Bryant Ranch Prepack	bf372e32-0902-447f-9673-00a3fcf0064c	2024-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: diclofenac sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	ba4677e4-00f8-44f6-a69b-e88ca28f6b2b	2024-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
kirkland signature arthritis pain relief	DICLOFENAC SODIUM	Costco Wholesale Company	8e53e5fa-fda2-4e3a-8c5a-82435e3d51c3	2024-11-01	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Bryant Ranch Prepack	ae0add8e-3a8a-4c5d-af3b-907f64211fef	2024-10-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	70156824-e5dd-42b1-9b4f-a49acb28d316	2024-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Asclemed USA, Inc	2e3e6de9-7e07-4df3-9fea-ac50ddcde840	2024-10-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	f5b4e308-c156-4865-95ee-1a8e267535ba	2024-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
good sense arthritis pain	DICLOFENAC SODIUM	A-S Medication Solutions	5f1ca9c1-c7fe-4a91-af5e-dc22b175f083	2024-09-26	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL GEL, 1%,	A-S Medication Solutions	4500bf3c-394b-4397-8751-8dac2097fc41	2024-09-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium
Diclofenac sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	22f4b8aa-902f-a860-e063-6394a90ada26	2024-09-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
Gencare-Arthritis Pain Relief	DICLOFENAC SODIUM	Pioneer Life Sciences, LLC	4b1438bb-8591-4237-abcb-91491f34ad8f	2024-09-10	Warnings	Name fallback generic name: DICLOFENAC SODIUM
diclofenac sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals, Inc.	20ef08a3-35cf-b4d6-e063-6394a90a012e	2024-08-30	Warnings	Name fallback brand name: diclofenac sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Harris Teeter	17ed520d-bfbe-4a33-e063-6394a90aa0f6	2024-08-30	Warnings	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals, Inc.	200c2800-a703-e138-e063-6394a90acc09	2024-08-19	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.