Application 019201

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VOLTAREN	DICLOFENAC SODIUM	TABLET, DELAYED RELEASE;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	VOLTAREN	DICLOFENAC SODIUM	TABLET, DELAYED RELEASE;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	VOLTAREN	DICLOFENAC SODIUM	TABLET, DELAYED RELEASE;ORAL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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	RLD / RS	Approval date
N019201-001	VOLTAREN	DICLOFENAC SODIUM	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28
N019201-002	VOLTAREN	DICLOFENAC SODIUM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28
N019201-003	VOLTAREN	DICLOFENAC SODIUM	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019201-001	VOLTAREN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019201-002	VOLTAREN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019201-003	VOLTAREN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019201-001	VOLTAREN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019201-002	VOLTAREN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019201-003	VOLTAREN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019201-001	VOLTAREN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019201-002	VOLTAREN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019201-003	VOLTAREN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019201-001	VOLTAREN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019201-002	VOLTAREN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019201-003	VOLTAREN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019201-001	VOLTAREN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019201-002	VOLTAREN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019201-003	VOLTAREN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019201-001	VOLTAREN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019201-002	VOLTAREN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019201-003	VOLTAREN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019201-001	VOLTAREN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019201-002	VOLTAREN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019201-003	VOLTAREN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019201-001	VOLTAREN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019201-002	VOLTAREN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019201-003	VOLTAREN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019201-001	VOLTAREN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019201-002	VOLTAREN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019201-003	VOLTAREN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019201-001	VOLTAREN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019201-002	VOLTAREN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019201-003	VOLTAREN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019201-001	VOLTAREN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019201-002	VOLTAREN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019201-003	VOLTAREN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019201-001	VOLTAREN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019201-002	VOLTAREN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019201-003	VOLTAREN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019201-001	VOLTAREN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019201-002	VOLTAREN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019201-003	VOLTAREN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019201-001	VOLTAREN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`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 13 of 14 · 273 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good sense arthritis pain	DICLOFENAC SODIUM	L. Perrigo Company	7b32b9e4-6502-4fa3-808f-3bef9525b6a1	2023-05-10	Warnings	Name fallback generic name: DICLOFENAC SODIUM
arthritis pain reliever	DICLOFENAC SODIUM	H E B	e8fe4a89-586d-461c-b242-b68e38a508b4	2023-03-09	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Quality Care Products LLC	94422b85-28ed-477f-853a-71d1d6cf17d5	2023-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Proficient Rx LP	73a46413-ecbc-4453-814d-bec955b375d2	2023-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	b41335b6-859f-4568-84d2-0d0408415a4e	2023-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Costco Wholesale	141b6693-6d6c-45c6-9b82-ee1afcfca12a	2023-01-27	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Proficient Rx LP	b98d921a-2ee7-4770-ac21-d845b2dcc11c	2023-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Arthritis Pain Reliever	DICLOFENAC SODIUM	P & L Development, LLC	2596645a-b736-4d3c-82a0-00713f1b6fbd	2022-12-15	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac	DICLOFENAC SODIUM	Altaire Pharmaceuticals Inc.	5372866a-dab3-45c8-8c2a-755ca36c1791	2022-10-28	Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Asclemed USA, Inc.	d4b81a74-6926-4715-bf90-aec026cff2b4	2022-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Asclemed USA, Inc.	b162d65d-b105-4a68-90bb-316b9686267b	2022-08-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Rite Aid Corporation	1c9ea3b2-8f45-420b-87d3-dc7de0be2d5f	2022-08-23	Warnings	Name fallback generic name: DICLOFENAC SODIUM
diclofenac sodium	DICLOFENAC SODIUM	Proficient Rx LP	67e384c6-8476-4aad-b967-241335538d56	2022-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Proficient Rx LP	afce2de2-0c59-4191-bf79-782ca31e427d	2022-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	3a520306-fe3e-4830-963f-04b080db3abc	2022-06-01	Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
good sense arthritis pain	DICLOFENAC SODIUM	Proficient Rx LP	67eacd91-8378-47e7-9bad-1e7b685aa9d4	2022-06-01	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	9eeb2aef-3eb1-4583-8180-d480deb3651c	2022-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	1c1ee94c-60d6-4cfc-bb66-1d4f6e630512	2022-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Proficient Rx LP	947c0c1f-3573-4f69-ab82-8b50c43e5586	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Arthritis Pain Reliever	DICLOFENAC SODIUM	CVS PHARMACY, INC	047985ea-f768-4f9a-bfe3-0acf40a4781d	2022-02-15	Warnings	Name fallback generic name: DICLOFENAC SODIUM

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67339	SUPPL	2021-05-03
67338	SUPPL	2021-05-03
67249	SUPPL	2021-04-29
1251	SUPPL	2016-05-12
33706	SUPPL	2016-05-11
33705	SUPPL	2011-03-04
11450	SUPPL	2011-03-04
16213	SUPPL	2011-02-28
1250	SUPPL	2011-02-28
23132	ORIG	2009-12-04
33704	SUPPL	2009-03-17
16212	SUPPL	2009-02-27
1249	SUPPL	2007-07-16
11449	SUPPL	2007-07-10
16211	SUPPL	2006-01-30
33703	SUPPL	2006-01-25
20213	SUPPL	2005-02-08
1248	SUPPL	2002-11-26