Application 020254

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VOLTAREN-XR	DICLOFENAC SODIUM	TABLET, EXTENDED RELEASE;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020254-001	VOLTAREN-XR	DICLOFENAC SODIUM	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1996-03-08

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 2 · 43 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	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020254-001	VOLTAREN-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020254-001	VOLTAREN-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`f41ea6bd6efb…`

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 2 of 14 · 273 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC SODIUM	American Health Packaging	dbb1489d-b690-4e53-905d-7fb07ad263b3	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
ARTHRITIS PAIN RELIEF	DICLOFENAC SODIUM	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	84978746-4ab5-456d-af63-5c86ab0a05f5	2026-06-29	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	10991fe6-fafd-49af-9684-83b447c19c67	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	REMEDYREPACK INC.	6980431d-4a2b-41e9-ae86-d46b4513f04b	2026-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	ASCLEMED USA INC.	53e8ad44-ff67-d3bb-e063-6394a90a524d	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	St. Mary's Medical Park Pharmacy	5f4b69de-8ddd-26c5-e053-2a91aa0ab326	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Golden State Medical Supply, Inc.	c1d87003-f54b-4381-9e11-1c39ea2d9eb3	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	081b43f9-f594-4b1e-8564-7dbbea6fa5bd	2026-05-26	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	1eb7a7bb-c524-4168-8ade-4601dc11533b	2026-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
arthritis pain reliever	DICLOFENAC SODIUM	HyVee Inc	bc74d53d-4142-4391-935b-61b7e353bd65	2026-04-30	Warnings	Name fallback generic name: DICLOFENAC SODIUM
TOPCARE ARTHRITIS PAIN RELIEVER	DICLOFENAC SODIUM	Topco Associates LLC	1d6c4c38-3739-4d58-9811-bac09fcbfadb	2026-04-24	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	7e940ce5-0f82-4d07-b507-c644481879c1	2026-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Walgreens	33a37e3d-0463-428c-9169-240eeb77af2b	2026-04-21	Warnings	Name fallback generic name: DICLOFENAC SODIUM
EQUATE ARTHRITIS PAIN	DICLOFENAC SODIUM	WALMART INC.	d05b5f82-8772-4e01-8eb3-6fa6042f5661	2026-04-20	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Bryant Ranch Prepack	b28e4a68-f396-4c1a-ba38-6a972906b4d0	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	REMEDYREPACK INC.	96f8c42c-db34-43b0-a891-33dd8e39e74f	2026-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	e947653c-6789-4c15-82c9-4b1402f6d6ac	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	ed1b5ec7-2812-4a81-90d1-953baa0b0ec8	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Aurolife Pharma LLC	dfb7afdf-5c05-4487-9044-936e151e5ba6	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	5d0a4b41-afbf-45e7-bb1c-587d72314ee0	2026-04-02	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-1381	Diclofenac Sodium	Diclofenac Sodium	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
33358-451	Diclofenac Sodium	Diclofenac Sodium	RxChange Co.	NDA AUTHORIZED GENERIC	Current
63187-041	Diclofenac Sodium	Diclofenac Sodium	Proficient Rx LP	ANDA	Current
63629-5096	Diclofenac Sodium	Diclofenac Sodium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-5096	Diclofenac Sodium	Diclofenac Sodium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
68788-9389	Diclofenac Sodium	Diclofenac Sodium	Preferred Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68788-9389	Diclofenac Sodium	Diclofenac Sodium	Preferred Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67343	SUPPL	2021-05-03
67342	SUPPL	2021-05-03
67253	SUPPL	2021-04-29
43643	SUPPL	2016-05-18
24665	SUPPL	2016-05-12
34438	SUPPL	2016-05-11
41232	SUPPL	2015-11-05
34437	SUPPL	2011-03-04
12376	SUPPL	2011-03-04
24664	SUPPL	2011-02-28
2251	SUPPL	2011-02-28
34436	SUPPL	2009-03-17
24663	SUPPL	2009-02-27
2250	SUPPL	2006-01-30
34435	SUPPL	2006-01-25