Application 022122

Type: NDA
Sponsor: GLAXOSMITHKLINE CONS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VOLTAREN ARTHRITIS PAIN	DICLOFENAC SODIUM	GEL;TOPICAL	1%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N022122-001	VOLTAREN ARTHRITIS PAIN	DICLOFENAC SODIUM	1%	GEL / TOPICAL		RLD, RS	2007-10-17

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022122-001	VOLTAREN	1%	GEL / TOPICAL	AB	RLD, RS	2007-10-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022122-001	VOLTAREN	1%	GEL / TOPICAL	AB	RLD, RS	2007-10-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022122-001	VOLTAREN	1%	GEL / TOPICAL	AB	RLD, RS	2007-10-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022122-001	VOLTAREN	1%	GEL / TOPICAL	AB	RLD, RS	2007-10-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022122-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022122-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022122-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022122-001	AB	1	`ea99ee380514…`

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Voltaren Arthritis Pain	DICLOFENAC SODIUM	Haleon US Holdings LLC	30a94282-0892-442a-aa10-6525cbd4fe88	2025-02-11	Warnings	Exact identifier application applno (NDA): 022122 application number: NDA022122 ndc (product): 0067-8152 ndc (product): 0067-8153
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	a7447467-79e0-436e-a273-d1ddd06169cf	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022122 application number: NDA022122 ndc (product): 63187-753

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0067-8152	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8152	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8152	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8152	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8152	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8152	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8152	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8153	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8153	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8153	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8153	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8153	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8153	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8153	Voltaren	diclofenac sodium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
21695-791	Voltaren	diclofenac sodium	Rebel Distributors Corp	NDA	Current
35356-187	Voltaren	diclofenac sodium	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
35356-187	Voltaren	diclofenac sodium	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
49884-935	Diclofenac Sodium	diclofenac sodium	Par Pharmaceutical Inc	NDA AUTHORIZED GENERIC	Current
49884-935	Diclofenac Sodium	diclofenac sodium	Par Pharmaceutical Inc	NDA AUTHORIZED GENERIC	Current
49884-935	Diclofenac Sodium	diclofenac sodium	Par Pharmaceutical Inc	NDA AUTHORIZED GENERIC	Current
50090-1099	Voltaren	diclofenac sodium	A-S Medication Solutions	NDA	Current
50090-2801	Diclofenac Sodium	diclofenac sodium	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-2801	Diclofenac Sodium	diclofenac sodium	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-4246	Diclofenac Sodium	diclofenac sodium	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50436-3621	Voltaren	diclofenac sodium	Unit Dose Services	NDA	Current
55700-528	Diclofenac Sodium	diclofenac sodium	Lake Erie Medical DBA Quality Care Products LLC	NDA AUTHORIZED GENERIC	Current
55700-528	Diclofenac Sodium	diclofenac sodium	Lake Erie Medical DBA Qua	NDA AUTHORIZED	Current
61919-592	VOLTAREN	VOLTAREN	DIRECT RX	NDA	Current
63187-582	Voltaren	diclofenac sodium	Proficient Rx LP	NDA	Current
63187-582	Voltaren	diclofenac sodium	Proficient Rx LP	NDA	Current
63187-753	Diclofenac Sodium	diclofenac sodium	Proficient Rx LP	NDA AUTHORIZED GENERIC	Current
63187-753	Diclofenac Sodium	diclofenac sodium	Proficient Rx LP	NDA AUTHORIZED GENERIC	Current
63481-684	Voltaren	diclofenac sodium	Endo Pharmaceuticals Inc.	NDA	Current
63481-684	Voltaren	diclofenac sodium	Endo Pharmaceuticals Inc.	NDA	Current
63481-684	Voltaren	diclofenac sodium	Endo Pharmaceuticals Inc.	NDA	Current
63629-4941	Voltaren	diclofenac sodium	Bryant Ranch Prepack	NDA	Current
63629-4941	Voltaren	diclofenac sodium	Bryant Ranch Prepack	NDA	Current
63629-7069	Diclofenac Sodium	diclofenac sodium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-7069	Diclofenac Sodium	diclofenac sodium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
68071-4382	Diclofenac Sodium	diclofenac sodium	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68071-4382	Diclofenac Sodium	diclofenac sodium	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68387-456	Voltaren	diclofenac sodium	Keltman Pharmaceuticals Inc.	NDA	Current
68788-9338	Voltaren	diclofenac sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
69621-814	Diclo Gel 1% with Xrylix Sheets	diclofenac sodium	Shoreline Pharmaceuticals, Inc.	NDA	Current
70518-1578	Voltaren	diclofenac sodium	REMEDYREPACK INC.	NDA	Current
70518-1578	Voltaren	diclofenac sodium	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79355	SUPPL	2024-08-09
79347	SUPPL	2024-08-09
76868	SUPPL	2023-12-15
76698	SUPPL	2023-12-15
73593	SUPPL	2023-02-22
73591	SUPPL	2023-02-22
72718	SUPPL	2022-11-27
72698	SUPPL	2022-11-25
69284	SUPPL	2021-11-09
69233	SUPPL	2021-11-05
68561	SUPPL	2021-09-08
68555	SUPPL	2021-09-08
65923	SUPPL	2021-01-19
65596	SUPPL	2020-12-15
61903	SUPPL	2020-02-14
61902	SUPPL	2020-02-14
54453	SUPPL	2018-06-05
52725	SUPPL	2018-02-26
52694	SUPPL	2018-02-23
52693	SUPPL	2018-02-23
29295	SUPPL	2016-05-11
16989	SUPPL	2016-05-11
16988	SUPPL	2015-01-05
29294	SUPPL	2014-11-28
29293	SUPPL	2009-11-10
38287	SUPPL	2009-10-01
42424	ORIG	2008-02-22
24245	ORIG	2008-02-22
29292	ORIG	2007-10-22
16987	ORIG	2007-10-22