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 9 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	Preferred Pharmaceuticals Inc.	6d5243ae-4a1a-4583-9337-085520e1f14a	2025-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	c933eaad-ba53-4130-90db-a66f89dfc29f	2025-03-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Oceanside Pharmaceuticals	c48113e0-9f1e-4086-b18f-3204c0d2a689	2025-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Cipla USA Inc.	daf52f5a-1bb7-4808-ab98-483ab9e8cfa0	2025-03-11	Warnings	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Alembic Pharmaceuticals Limited	048ede6a-b7cd-4100-8979-519bd44906c8	2025-03-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	31b56330-6870-48b7-a8c4-0639e0766b25	2025-03-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL	Alembic Pharmaceuticals Limited	11adfe0f-e774-4ccf-8a57-0c7d47aeb0dd	2025-03-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium
Voltaren Arthritis Pain	DICLOFENAC SODIUM	Haleon US Holdings LLC	30a94282-0892-442a-aa10-6525cbd4fe88	2025-02-11	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Bryant Ranch Prepack	af480e78-ff65-4709-af26-c430aefb77d6	2025-02-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Asclemed USA, Inc.	5508f80d-5f11-4959-8e42-9055f0169cfc	2025-02-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	0d1d19e5-4ffe-af95-e063-6394a90a7abf	2025-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	d70fcd8e-a72b-41ef-ac26-e0f2f279f062	2025-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Actavis Pharma, Inc.	74169b2d-ac56-4757-86c4-cdcfcd5f4eb5	2025-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Coupler LLC	2ce0741a-7bc7-8aec-e063-6294a90ae9ef	2025-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Bryant Ranch Prepack	49013aad-475c-4efb-84c6-15a5d4664fbf	2025-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Aspercreme Arthritis	DICLOFENAC SODIUM	Chattem, Inc.	762b7ef4-166c-43b8-9acd-2b9e7fa0bf36	2025-01-28	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Direct_Rx	f80b0b95-f4da-2d6c-e053-6294a90acf92	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Direct_Rx	0c41977f-8dad-1d26-e063-6294a90a9b22	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	DIRECT RX	a5b33bf7-8113-9c54-e053-2995a90a79d8	2025-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC SODIUM generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Alembic Pharmaceuticals Inc.	02e90e33-384f-4e29-b508-2503def22214	2025-01-17	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.