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DICLOFENAC SODIUM	TABLET, DELAYED RELEASE;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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DICLOFENAC SODIUM	TABLET, DELAYED RELEASE;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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DICLOFENAC SODIUM	TABLET, DELAYED RELEASE;ORAL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N019201-001	VOLTAREN	DICLOFENAC SODIUM	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28
N019201-002	VOLTAREN	DICLOFENAC SODIUM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28
N019201-003	VOLTAREN	DICLOFENAC SODIUM	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28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N019201-001	VOLTAREN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`84e616aacf4f…`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 4 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	Sportpharm LLC	99f1e69e-02cf-49c2-83af-3cccbbea4215	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	0cefb675-c54e-44eb-b35c-38354b77eddd	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	74011b00-7e2e-40a7-ab30-c05a20559814	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Umedica Laboratories USA Inc.	0e5c6669-390f-4c32-b9b8-13ed3c517462	2026-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Arthritis Pain Reliever	DICLOFENAC SODIUM	Family Dollar (FAMILY WELLNESS)	03ddf347-a3a3-4313-87d1-a246c1d4e0b4	2026-01-29	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Golden State Medical Supply, Inc.	468fab22-2b69-4a2c-e063-6294a90aab9a	2026-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Bausch & Lomb Incorporated	39dfffb0-612a-48f3-8db5-1a59899b91e9	2026-01-27	Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Ingenus Pharmaceuticals, LLC	1a237198-ca24-4159-b570-b5a23c8e91b0	2026-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	4ee64a93-9965-47c8-be2c-14232df44b2b	2026-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	A-S Medication Solutions	f92576d7-3ad9-43a3-8b10-3a29fbf712a4	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	A-S Medication Solutions	6c57e330-ebbe-4165-84a8-4844b2f0097e	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
ARTHRITIS PAIN RELIEVER	DICLOFENAC SODIUM	Publix Super Markets Inc	bae07276-c800-468e-a201-e6268846fff3	2026-01-15	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	47793dca-5e9e-44ee-8e66-5e42e1831b1e	2026-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	b74be49d-74ff-491b-962b-0edd3a57cbc9	2026-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM TOPICAL	DICLOFENAC SODIUM	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	181e32ab-5ec0-4be4-bad0-b6bbafc08f85	2026-01-15	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Sportpharm LLC	929f71ab-f0c8-4331-800d-ed4a172e647e	2026-01-14	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Sportpharm LLC	ac631742-119f-408a-8b36-b041bab743e2	2026-01-14	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	AvKARE	19b4ff5c-adb7-a0d0-7ef2-4ae05047fd94	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	AvKARE	0416ce03-c345-9d9e-e063-6294a90ad940	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Aspercreme Arthritis	DICLOFENAC SODIUM	Chattem, Inc.	81f78685-c416-48b5-8840-eef03a66bc28	2026-01-12	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