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DICLOFENAC SODIUM	TABLET, DELAYED RELEASE;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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DICLOFENAC SODIUM	TABLET, DELAYED RELEASE;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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DICLOFENAC SODIUM	TABLET, DELAYED RELEASE;ORAL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N019201-001	VOLTAREN	DICLOFENAC SODIUM	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28
N019201-002	VOLTAREN	DICLOFENAC SODIUM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28
N019201-003	VOLTAREN	DICLOFENAC SODIUM	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28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 2 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
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019201-002	VOLTAREN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	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	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	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	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	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	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	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	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	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	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	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	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	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	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	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	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	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	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	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	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019201-001	VOLTAREN	25MG	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019201-002	VOLTAREN	50MG	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019201-003	VOLTAREN	75MG	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019201-001	VOLTAREN	25MG	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019201-002	VOLTAREN	50MG	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019201-003	VOLTAREN	75MG	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019201-001	VOLTAREN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019201-002	VOLTAREN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019201-003	VOLTAREN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	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	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	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	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	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	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019201-001	VOLTAREN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019201-002	VOLTAREN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019201-003	VOLTAREN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019201-001	VOLTAREN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019201-002	VOLTAREN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019201-003	VOLTAREN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019201-001	VOLTAREN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019201-002	VOLTAREN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019201-003	VOLTAREN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019201-001	VOLTAREN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019201-002	VOLTAREN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019201-003	VOLTAREN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019201-001	VOLTAREN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019201-002	VOLTAREN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019201-003	VOLTAREN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019201-001	VOLTAREN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019201-002	VOLTAREN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, DELAYED RELEASE / ORAL	RLD	1988-07-28	`3f01610625f2…`

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 1 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	A-S Medication Solutions	d9698809-4887-4514-aa28-0066355ef908	2026-09-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	NuCare Pharmaceuticals, Inc.	5a852412-69af-6502-e063-6294a90a0748	2026-09-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac	DICLOFENAC SODIUM	YYBA CORP	533653e8-93d5-9080-e063-6394a90a165b	2026-09-01	Warnings	Name fallback generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Northwind Health Company, LLC	5990259d-2f90-20d3-e063-6394a90a3d23	2026-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
AMAZON BASIC CARE ARTHRITIS PAIN	DICLOFENAC SODIUM	Amazon.com Services LLC	113e2f87-c408-3e44-e063-6394a90a0a7f	2026-08-20	Warnings	Name fallback generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Northwind Health Company, LLC	4dde6e36-7540-1cc3-e063-6294a90a3941	2026-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Sportpharm LLC	e9ec5462-939a-4022-8946-5d81869a6277	2026-08-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	2a7019e9-e20f-4897-9b8e-942a7f2b34f6	2026-08-12	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	226da8a2-807d-4784-8d33-b434f3951a52	2026-08-12	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	PD-Rx Pharmaceuticals, Inc.	681b6b25-4a28-44f2-8042-d5e01a502116	2026-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals, Inc.	57c83158-f072-6fa2-e063-6394a90aee2c	2026-07-29	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	ddd2278b-70be-41ca-8a84-e3fe0f1a1561	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	CVS Pharmacy	591cc2ed-e667-4779-a426-8a2e6f873573	2026-07-22	Warnings	Name fallback generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Aurobindo Pharma Limited	d9b6f1d0-1710-46fb-8ea4-80b3ca60a575	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	HAWAII REPACK, INC	ea113a58-c7ed-4768-9777-93d9b166dfbe	2026-07-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	American Health Packaging	63c00b50-06d3-4659-81cf-be4516429e81	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	REMEDYREPACK INC.	6e6a6f98-5517-4f67-9a6a-71019ba2d773	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	71a823c4-9c88-474d-b525-276f9e7808aa	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	09643e65-f301-4891-96f4-d78bf3621e23	2026-07-02	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	30c7e4fd-30af-4d28-a6ef-7386ff83cfb8	2026-07-02	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.

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