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SODIUM	TABLET, EXTENDED RELEASE;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N020254-001	VOLTAREN-XR	DICLOFENAC SODIUM	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1996-03-08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N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`84e616aacf4f…`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N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`caaa826d4ba7…`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UTC	2026-02	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`011fe1cb6892…`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of this ZIP	2025-12	N020254-001	VOLTAREN-XR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1996-03-08	`31067a03dcf5…`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 5 of 14 · 273 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	14c1b1a1-bc06-4722-9612-e88ae52272bc	2026-01-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	1e669fc2-69bf-4439-a336-a103e5b9cafe	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	8825dc2c-3497-455f-b5e1-2aa667291957	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	PHOENIX RX LLC	47ce6fab-be1d-0076-e063-6294a90add63	2026-01-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Arthritis Pain Reliever	DICLOFENAC SODIUM	QUALITY CHOICE (Chain Drug Marketing Association)	98f94aa2-6bc2-4c07-81c8-63b2c262cf39	2026-01-06	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Northwind Health Company, LLC	c16e7e43-3869-9fef-e053-2995a90a1fdb	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Northwind Health Company, LLC	f2b7ea75-738b-54a8-e053-2995a90a00d5	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	47a7a294-55bb-8d19-e063-6394a90a5440	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	40388047-7fbe-49bf-bed8-e5087bed4e03	2025-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	4a88f136-f7c7-47d7-b85d-8a2f9f118f09	2025-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Safeway, Inc.	196d8af7-739f-4d2c-8c4e-9d33e6d722ab	2025-12-23	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Redpharm Drug	325213a3-241c-18d2-e063-6394a90a40f7	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	58063c26-86fe-4f03-97ef-51706e5f4054	2025-12-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Redpharm Drug	37362eb4-db16-f4ad-e063-6394a90a42aa	2025-12-13	Warnings	Name fallback generic name: DICLOFENAC SODIUM
UP AND UP ARTHRITIS PAIN RELIEVER	DICLOFENAC SODIUM	Target Corporation	3a9b32af-a3cd-496b-9698-0421443e0385	2025-12-08	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	4539e9e7-5d82-3b36-e063-6394a90a1396	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Aleve Arthritis Pain Gel	DICLOFENAC SODIUM	Bayer HealthCare LLC	bad675d1-1204-0136-e053-2995a90a994e	2025-12-04	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Aurobindo Pharma Limited	e5c0863a-edb7-4f46-a396-c9b2d8785cf8	2025-11-19	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	SOLA Pharmaceuticals, LLC	b8072af2-9940-4827-9fbd-de46ad8bf929	2025-11-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
ARTHRITIS PAIN RELIEVER	DICLOFENAC SODIUM	H E B	027803c5-85ae-4b86-8bd4-e61f8f34d036	2025-11-17	Warnings	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